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Fludarabine (Fludara®) Plus Alemtuzumab (CAMPATH®, MabCampath®) vs Fludarabine Alone in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients

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ClinicalTrials.gov Identifier: NCT00086580
Recruitment Status : Completed
First Posted : July 8, 2004
Results First Posted : August 11, 2011
Last Update Posted : March 13, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition B-Cell Chronic Lymphocytic Leukemia
Interventions Biological: FluCAM [Fludara + Campath]
Biological: fludarabine phosphate
Enrollment 335
Recruitment Details  
Pre-assignment Details Treatment was from initiation of study drug(s) to 4 weeks after last administration of study drug. Follow-up was for those without disease progression and ended upon disease progression or primary endpoint analysis whichever came first. Observation included those with disease progression who were observed for alternative rx and overall survival.
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle. Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Period Title: Treatment Period
Started 168 167
Safety Population 164 [1] 165 [2]
Completed 103 [3] 107 [4]
Not Completed 65 60
Reason Not Completed
Disease progression             9             8
Unable to comply with protocol             3             1
Withdrawal by Subject             7             8
Physician Decision             13             7
AE - not treatment related             7             7
Toxicity - treatment related             15             15
Anemia or thrombocytopenia             1             4
Death             5             7
Not specified             5             3
[1]
Four participants did not receive treatment
[2]
Two participants did not receive treatment
[3]
Finished 6 cycles of study drugs
[4]
Finished 6 cycles of study drug
Period Title: Follow-up Period
Started 141 137
Completed 37 18
Not Completed 104 119
Reason Not Completed
Disease progression             72             99
Unable to comply with protocol             5             0
Withdrawal by Subject             6             6
Physician Decision             0             1
AE - not related             1             0
Death             13             7
Not specified             7             6
Period Title: Observation Period
Started 95 121
Completed 49 56
Not Completed 46 65
Reason Not Completed
Unable to comply with protocol             1             1
Withdrawal by Subject             4             2
Death             33             55
Not specified             8             7
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone Total
Hide Arm/Group Description Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle. Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles. Total of all reporting groups
Overall Number of Baseline Participants 168 167 335
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 168 participants 167 participants 335 participants
60.0  (9.25) 60.8  (9.34) 60.4  (9.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 168 participants 167 participants 335 participants
Female
59
  35.1%
59
  35.3%
118
  35.2%
Male
109
  64.9%
108
  64.7%
217
  64.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 168 participants 167 participants 335 participants
White 167 167 334
Other 1 0 1
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 168 participants 167 participants 335 participants
169.0  (8.88) 169.4  (9.30) 169.2  (9.08)
Body Surface Area (BSA)  
Mean (Standard Deviation)
Unit of measure:  Meters^2
Number Analyzed 168 participants 167 participants 335 participants
1.87  (0.213) 1.90  (0.218) 1.88  (0.216)
Maximum Lymph Node Size   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 168 participants 167 participants 335 participants
<5 centimeters 134 136 270
>= 5 centimeters 34 31 65
[1]
Measure Description: The number of participants whose largest lymph node by physical exam assessment during a baseline visit fell within two categories: <5 cm and >=5 cm. If there is no enlarged lymph node, then size is classified as <5 cm.
World Health Organization (WHO) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 168 participants 167 participants 335 participants
WHO Performance Status = 0 81 72 153
WHO Performance Status = 1 87 95 182
[1]
Measure Description: Per protocol, all participants had a WHO performance status of 0 or 1. A WHO performance status of 0 is defined as "patient is able to carry out all normal activity without restriction," and status of 1 is "patient is ambulatory and capable of all self-care but unable to carry out any work; up and about more than 50% of waking hours."
Rai Stage Group   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 168 participants 167 participants 335 participants
Rai Stage 0 2 2 4
Rai Stage I - II 104 102 206
Rai Stage III - IV 62 63 125
[1]
Measure Description:

Rai staging is a way to categorize the disease progression of chronic lymphocytic leukemia (CLL); higher stages reflect increasing severity.

Rai Stage 0: Lymphocytosis only, Rai Stage I: Lymphocytosis with lymphadenopathy, Rai Stage II: Lymphocytosis with hepatomegaly or splenomegaly, Rai Stage III: Lymphocytosis with anemia, Rai Stage IV: Lymphocytosis with thrombocytopenia.

Per protocol, the 4 participants with Rai Stage 0 were eligible for the study because they had Binet Stage A.

Binet Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 168 participants 167 participants 335 participants
Binet Stage A 27 25 52
Binet Stage B 89 89 178
Binet Stage C 52 53 105
[1]
Measure Description:

Binet staging classifies CLL according to the number of lymphoid tissues involved, as well as the presence of low red blood cell count (anemia) or low number of blood platelets (thrombocytopenia).

Binet Stage A: fewer than three areas of enlarged lymphoid tissue. Enlarged lymph nodes of the neck, underarms, and groin, as well as the spleen, are each considered "one group," whether unilateral (one-sided) or bilateral (on both sides).

Binet Stage B: more than three areas of enlarged lymphoid tissue.

Binet Stage C: anemia plus thrombocytopenia (platelets <100 x 10^3/dL).

Disease Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 168 participants 167 participants 335 participants
Relapsed 101 101 202
Refractory 67 66 133
[1]
Measure Description: Count of participants with refractory or relapsed disease at baseline (as reported by the investigator).
Summary of Prior Therapy by Type of Therapy   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 168 participants 167 participants 335 participants
Fludarabine-containing therapy 25 26 51
Non-fludarabine-containing therapy 143 141 284
[1]
Measure Description: Count of participants who had prior therapy categorized by type of therapy: fludarabine-containing therapy or non-fludarabine-containing therapy.
1.Primary Outcome
Title Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) Assessment
Hide Description Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 168 167
Median (95% Confidence Interval)
Unit of Measure: months
23.65
(19.180 to 28.360)
16.48
(12.500 to 21.220)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combination Arm (FluCAM), Fludarabine Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments Cox proportional hazards model was stratified by Rai Stage Group
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.610
Confidence Interval (2-Sided) 95%
0.467 to 0.795
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP)
Hide Description Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology.
Time Frame Up to 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 168 167
Measure Type: Number
Unit of Measure: participants
Overall Response (CR+PR) 137 126
Complete Response (CR) 21 7
Partial Response (PR) 116 119
Progressive Disease (PD) 6 9
Stable Disease (SD) 12 21
Not Evaluable (NE) 13 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combination Arm (FluCAM), Fludarabine Alone
Comments Comparison of Overall Response.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.178
Comments P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.
Method Cochran-Mantel-Haenszel
Comments CMH chi-square test for a difference in overall response rates between treatments stratified by Rai Stage Group.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.03 to 0.15
Estimation Comments Difference and confidence interval (CI) calculated using the recommended method by Altman et al.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Combination Arm (FluCAM), Fludarabine Alone
Comments Comparison of complete response (CR).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.
Method Cochran-Mantel-Haenszel
Comments CMH chi-square test for a difference in complete response rates between treatments stratified by Rai Stage Group.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
0.02 to 0.15
Estimation Comments Difference and confidence interval (CI) calculated using the recommended method by Altman et al.
3.Secondary Outcome
Title Kaplan-Meier Estimates of Overall Survival Time
Hide Description Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 168 167
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
52.93 [1] 
(40.890 to NA)
[1]
NA = values were not calculable since there were not enough events for the statistical estimation, ie, few participants died
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combination Arm (FluCAM), Fludarabine Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.
Method Regression, Cox
Comments Cox proportional hazards model stratified by Rai Stage Group
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.648
Confidence Interval (2-Sided) 95%
0.449 to 0.937
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Kaplan Meier Estimates for Time to Disease Progression Assessed by the Independent Response Review Panel (IRRP)
Hide Description Time to disease progression was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease as determined by IRRP. Results are stated in months.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 168 167
Median (95% Confidence Interval)
Unit of Measure: months
27.96
(22.340 to 31.910)
18.68
(14.510 to 23.220)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combination Arm (FluCAM), Fludarabine Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments Cox regression model stratified by Rai Stage Group.
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.562
Confidence Interval (2-Sided) 95%
0.420 to 0.752
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Kaplan-Meier Estimates for Duration of Response Assessed by the Independent Response Review Panel (IRRP)
Hide Description Duration of response was analyzed for participants who achieved a complete response (CR) or partial response (PR) and was defined as the number of days from the first date of documented response to the date of progressive disease as determined by IRRP or death due to any cause. Results are stated in months.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants who achieved a complete response or a partial response as determined by the IRRP.
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 135 124
Median (95% Confidence Interval)
Unit of Measure: months
25.10
(20.200 to 29.280)
19.14
(14.140 to 21.910)
6.Secondary Outcome
Title Kaplan-Meier Estimates for Time to Alternative Therapy
Hide Description Time to alternative therapy was defined as the number of days from the date of randomization to the date of first alternative therapy for chronic lymphocytic leukemia (CLL) or death resulting from any cause. Participants who had not received alternative therapy as of the data cutoff date were censored at the last follow-up visit assessment date plus 1 day. Results are stated in months.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 168 167
Median (95% Confidence Interval)
Unit of Measure: months
25.43
(20.130 to 41.810)
22.01
(20.130 to 27.830)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combination Arm (FluCAM), Fludarabine Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Regression, Cox
Comments Cox proportional hazards model stratified by Rai Stage Group.
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.718
Confidence Interval (2-Sided) 95%
0.543 to 0.951
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Mean EQ-5D™ Index Scores to Measure Quality of Life at Baseline
Hide Description EQ-5D™ is a trademark of the EuroQol Group. EQ-5D™ is a standardized instrument for use as a measure of health outcome. The questionnaire asks about health status along 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression, which are rated at three possible levels (no problems, some problems, extreme problems). The score ranges from best (+1) to worst (-0.59).
Time Frame Day 0 (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis dataset. Participants who provided valid answers on questionnaires are included.
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 168 164
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.7959  (0.1868) 0.7822  (0.2023)
8.Secondary Outcome
Title Mean EQ-5D™ Index Scores to Measure Quality of Life at End of Treatment
Hide Description EQ-5D™ is a trademark of the EuroQol Group. EQ-5D™ is a standardized instrument for use as a measure of health outcome. The questionnaire asks about health status along 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression, which are rated at three possible levels (no problems, some problems, extreme problems). The score ranges from best (+1) to worst (-0.59).
Time Frame up to month 6 (end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis dataset. Participants who provided valid answers on questionnaires are included.
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 152 147
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.8049  (0.2752) 0.7749  (0.2569)
9.Secondary Outcome
Title Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at Baseline
Hide Description The EuroQol Visual Analogue Scale (EQ-VAS) was also used to capture the self-rating of current health status using a visual "thermometer" with the end points of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom.
Time Frame Day 0 (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Participants who provided valid answers on questionnaires are included.
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 167 161
Mean (Standard Deviation)
Unit of Measure: units on a scale
70.9  (18.01) 70.2  (17.24)
10.Secondary Outcome
Title Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at End of Treatment
Hide Description The EuroQol Visual Analogue Scale (EQ-VAS) was also used to capture the self-rating of current health status using a visual "thermometer" with the end points of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom.
Time Frame up to month 6 (end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Participants who provided valid answers on questionnaires are included.
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 152 146
Mean (Standard Deviation)
Unit of Measure: units on a scale
77.1  (19.41) 75.7  (17.98)
11.Secondary Outcome
Title Summary of Participants With Adverse Experiences (AEs)
Hide Description Number of participants with adverse events (AEs). AEs were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were assessed for relatedness to study treatment (4 point scale from 'not related' to 'definitely related'). Categories reported include participant counts for treatment-emergent AEs, AEs for infections, serious AEs, AEs causing discontinuation of study drug(s), and deaths. Related AEs for the combination arm can be related to either fludarabine or alemtuzumab.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 164 165
Measure Type: Number
Unit of Measure: participants
At least 1 treatment emergent AE 161 149
At least 1 related treatment emergent AE 159 125
At least 1 treatment-emergent infection 67 58
At least 1 drug-related infection 44 30
At least 1 serious AE 54 41
At least 1 related serious AE 47 28
Discontinuation of study drug due to AE 37 32
Discontinuation of study drug due to related AE 32 24
Deaths 10 12
Patients who died due to a related AE 7 6
Patients who died within 30 days of the last dose 4 7
12.Secondary Outcome
Title Mean Systemic Clearance (CL) of Fludarabine
Hide Description Clearance of drug from plasma is affected by the absorption, distribution, metabolism and elimination of the drug. Mean systemic clearance of fludarabine is derived from plasma concentration versus time data.
Time Frame month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: liters/hour
9.46  (4.31) 9.54  (3.10)
13.Secondary Outcome
Title Total Volume of Distribution (Vss) of Fludarabine
Hide Description The total volume of distribution (Vss) is the apparent volume in which fludarabine is distributed immediately after it has been injected intravenously and equilibrated between plasma and the surrounding tissues. Total volume of distribution (Vss) of fludarabine is derived from plasma concentration versus time data.
Time Frame month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: liters
117  (64.3) 172  (91.3)
14.Secondary Outcome
Title Area Under the Curve (AUC) of Fludarabine From (AUC 0-tau)
Hide Description AUC (0-tau) is the area under the plasma concentration curve for fludarabine over the dosage interval (tau).
Time Frame month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)
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Pharmacokinetic population
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
8203  (6531) 5669  (3888)
15.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Fludarabine
Hide Description Cmax is the maximum plasma concentration of fludarabine observed.
Time Frame month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
4084  (6089) 1847  (1637)
16.Secondary Outcome
Title Participants With Minimal Residual Disease (MRD)
Hide Description MRD negativity in this report was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. MRD was assessed in participants with a clinical complete response (CR) or partial response (PR) without recovery of blood counts. MRD represents a very positive outcome.
Time Frame up to 9 months
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Full analysis set
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 168 167
Measure Type: Number
Unit of Measure: participants
6 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combination Arm (FluCAM), Fludarabine Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH chi-square test for a difference in response rates between treatments stratified by Rai Stage Group.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
0.01 to 0.08
Estimation Comments [Not Specified]
17.Other Pre-specified Outcome
Title Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage I-II
Hide Description Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months and include participants with Rai stage I or II.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants with Rai stage I or II
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 104 102
Median (95% Confidence Interval)
Unit of Measure: months
23.75
(19.970 to 29.700)
20.76
(14.700 to 24.340)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combination Arm (FluCAM), Fludarabine Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.102
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.750
Confidence Interval (2-Sided) 95%
0.531 to 1.059
Estimation Comments [Not Specified]
18.Other Pre-specified Outcome
Title Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage III-IV
Hide Description Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months and include participants with Rai stage III or IV.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants with Rai stage III or IV
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 62 63
Median (95% Confidence Interval)
Unit of Measure: months
20.53
(14.310 to 31.910)
11.51
(8.980 to 14.670)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combination Arm (FluCAM), Fludarabine Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.443
Confidence Interval (2-Sided) 95%
0.292 to 0.671
Estimation Comments [Not Specified]
19.Other Pre-specified Outcome
Title Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage I-II
Hide Description Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months and include participants with Rai Stage I or II.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants with Rai Stage I or II
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 104 102
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(58.420 to NA)
NA [1] 
(57.430 to NA)
[1]
NA=values were not calculable since there were not enough events for the statistical estimation, ie, few participants died
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combination Arm (FluCAM), Fludarabine Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.819
Comments [Not Specified]
Method Regression, Cox
Comments Cox proportional hazards model
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.066
Confidence Interval (2-Sided) 95%
0.619 to 1.836
Estimation Comments [Not Specified]
20.Other Pre-specified Outcome
Title Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage III-IV
Hide Description Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months and include participants with Rai Stage III or IV.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants with Rai Stage III or IV
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description:
Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
Overall Number of Participants Analyzed 62 63
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(32.140 to NA)
23.52
(17.760 to 40.300)
[1]
NA=values were not calculable since there were not enough events for the statistical estimation, ie, few participants died
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combination Arm (FluCAM), Fludarabine Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments Cox proportional hazards model
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.416
Confidence Interval (2-Sided) 95%
0.250 to 0.690
Estimation Comments [Not Specified]
Time Frame Up to 6 years
Adverse Event Reporting Description In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
 
Arm/Group Title Combination Arm (FluCAM) Fludarabine Alone
Hide Arm/Group Description Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle. Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
All-Cause Mortality
Combination Arm (FluCAM) Fludarabine Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Combination Arm (FluCAM) Fludarabine Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   54/164 (32.93%)   41/165 (24.85%) 
Blood and lymphatic system disorders     
Anaemia  1  1/164 (0.61%)  6/165 (3.64%) 
Anaemia haemolytic autoimmune  1  2/164 (1.22%)  2/165 (1.21%) 
Autoimmune neutropenia  1  1/164 (0.61%)  0/165 (0.00%) 
Autoimmune thrombocytopenia  1  0/164 (0.00%)  1/165 (0.61%) 
Disseminated intravascular coagulation  1  0/164 (0.00%)  1/165 (0.61%) 
Febrile neutropenia  1  5/164 (3.05%)  7/165 (4.24%) 
Haemolytic anaemia  1  0/164 (0.00%)  2/165 (1.21%) 
Haemolytic uraemic syndrome  1  0/164 (0.00%)  1/165 (0.61%) 
Leukopenia  1  4/164 (2.44%)  1/165 (0.61%) 
Neutropenia  1  8/164 (4.88%)  2/165 (1.21%) 
Pancytopenia  1  2/164 (1.22%)  1/165 (0.61%) 
Thrombocytopenia  1  5/164 (3.05%)  1/165 (0.61%) 
Cardiac disorders     
Acute myocardial infarction  1  0/164 (0.00%)  1/165 (0.61%) 
Angina pectoris  1  1/164 (0.61%)  0/165 (0.00%) 
Cardiac arrest  1  1/164 (0.61%)  0/165 (0.00%) 
Cardiac failure  1  0/164 (0.00%)  2/165 (1.21%) 
Cardiogenic shock  1  0/164 (0.00%)  1/165 (0.61%) 
Cardiopulmonary failure  1  1/164 (0.61%)  0/165 (0.00%) 
Cardiovascular insufficiency  1  1/164 (0.61%)  2/165 (1.21%) 
Left ventricular dysfunction  1  1/164 (0.61%)  0/165 (0.00%) 
Pericardial effusion  1  1/164 (0.61%)  0/165 (0.00%) 
Supraventricular tachycardia  1  1/164 (0.61%)  1/165 (0.61%) 
Eye disorders     
Retinopathy  1  0/164 (0.00%)  1/165 (0.61%) 
Gastrointestinal disorders     
Anal fistula  1  0/164 (0.00%)  1/165 (0.61%) 
Colitis  1  1/164 (0.61%)  0/165 (0.00%) 
Diarrhoea  1  4/164 (2.44%)  0/165 (0.00%) 
Enterocolitis  1  1/164 (0.61%)  0/165 (0.00%) 
Femoral hernia, obstructive  1  1/164 (0.61%)  0/165 (0.00%) 
Gastritis  1  1/164 (0.61%)  0/165 (0.00%) 
Gastrointestinal hypermotility  1  1/164 (0.61%)  0/165 (0.00%) 
Lower gastrointestinal haemorrhage  1  0/164 (0.00%)  1/165 (0.61%) 
Nausea  1  1/164 (0.61%)  0/165 (0.00%) 
Pancreatitis acute  1  1/164 (0.61%)  0/165 (0.00%) 
Umbilical hernia  1  0/164 (0.00%)  1/165 (0.61%) 
Vomiting  1  2/164 (1.22%)  0/165 (0.00%) 
General disorders     
Fatigue  1  1/164 (0.61%)  0/165 (0.00%) 
Infusion related reaction  1  3/164 (1.83%)  0/165 (0.00%) 
Mucosal inflammation  1  1/164 (0.61%)  0/165 (0.00%) 
Multi-organ failure  1  0/164 (0.00%)  1/165 (0.61%) 
Pyrexia  1  5/164 (3.05%)  1/165 (0.61%) 
Sudden cardiac death  1  0/164 (0.00%)  1/165 (0.61%) 
Hepatobiliary disorders     
Hepatic failure  1  0/164 (0.00%)  1/165 (0.61%) 
Hepatitis  1  1/164 (0.61%)  0/165 (0.00%) 
Hepatitis cholestatic  1  1/164 (0.61%)  0/165 (0.00%) 
Hepatitis toxic  1  1/164 (0.61%)  0/165 (0.00%) 
Hepatotoxicity  1  1/164 (0.61%)  0/165 (0.00%) 
Immune system disorders     
Hypogammaglobulinaemia  1  1/164 (0.61%)  0/165 (0.00%) 
Infections and infestations     
Bronchitis  1  3/164 (1.83%)  0/165 (0.00%) 
Cellulitis  1  0/164 (0.00%)  1/165 (0.61%) 
Cytomegalovirus infection  1  2/164 (1.22%)  0/165 (0.00%) 
Erysipelas  1  0/164 (0.00%)  1/165 (0.61%) 
Eye infection toxoplasmal  1  1/164 (0.61%)  0/165 (0.00%) 
Fungaemia  1  0/164 (0.00%)  1/165 (0.61%) 
Gastroenteritis escherichia coli  1  0/164 (0.00%)  1/165 (0.61%) 
Hepatitis c  1  1/164 (0.61%)  0/165 (0.00%) 
Herpes simplex  1  0/164 (0.00%)  1/165 (0.61%) 
Herpes zoster  1  1/164 (0.61%)  0/165 (0.00%) 
Infection  1  0/164 (0.00%)  1/165 (0.61%) 
Oral fungal infection  1  0/164 (0.00%)  1/165 (0.61%) 
Orchitis  1  0/164 (0.00%)  1/165 (0.61%) 
Oropharyngeal candidiasis  1  1/164 (0.61%)  0/165 (0.00%) 
Peritonsillar abscess  1  1/164 (0.61%)  0/165 (0.00%) 
Pharyngitis  1  2/164 (1.22%)  0/165 (0.00%) 
Pharyngitis bacterial  1  0/164 (0.00%)  1/165 (0.61%) 
Pneumococcal sepsis  1  0/164 (0.00%)  1/165 (0.61%) 
Pneumocystis jiroveci infection  1  1/164 (0.61%)  0/165 (0.00%) 
Pneumocystis jiroveci pneumonia  1  1/164 (0.61%)  0/165 (0.00%) 
Pneumonia  1  5/164 (3.05%)  1/165 (0.61%) 
Pneumonia bacterial  1  0/164 (0.00%)  1/165 (0.61%) 
Pneumonia fungal  1  1/164 (0.61%)  2/165 (1.21%) 
Pneumonia streptococcal  1  0/164 (0.00%)  1/165 (0.61%) 
Pyelonephritis acute  1  1/164 (0.61%)  1/165 (0.61%) 
Respiratory tract infection  1  0/164 (0.00%)  1/165 (0.61%) 
Salmonella sepsis  1  1/164 (0.61%)  0/165 (0.00%) 
Sepsis  1  0/164 (0.00%)  2/165 (1.21%) 
Septic shock  1  0/164 (0.00%)  1/165 (0.61%) 
Sinusitis  1  1/164 (0.61%)  1/165 (0.61%) 
Tonsillitis  1  1/164 (0.61%)  0/165 (0.00%) 
Tuberculosis  1  1/164 (0.61%)  0/165 (0.00%) 
Investigations     
Cd4 lymphocytes decreased  1  1/164 (0.61%)  0/165 (0.00%) 
Cytomegalovirus test positive  1  3/164 (1.83%)  0/165 (0.00%) 
Pneumocystis test positive  1  1/164 (0.61%)  0/165 (0.00%) 
Transaminases increased  1  1/164 (0.61%)  0/165 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/164 (0.61%)  0/165 (0.00%) 
Hypokalaemia  1  1/164 (0.61%)  0/165 (0.00%) 
Tumour lysis syndrome  1  1/164 (0.61%)  0/165 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteochondrosis  1  0/164 (0.00%)  1/165 (0.61%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma  1  0/164 (0.00%)  1/165 (0.61%) 
Chronic lymphocytic leukaemia transformation  1  2/164 (1.22%)  0/165 (0.00%) 
Gastric cancer  1  1/164 (0.61%)  0/165 (0.00%) 
Hodgkin's disease  1  1/164 (0.61%)  0/165 (0.00%) 
Malignant melanoma  1  0/164 (0.00%)  1/165 (0.61%) 
Malignant peritoneal neoplasm  1  0/164 (0.00%)  1/165 (0.61%) 
Malignant pleural effusion  1  1/164 (0.61%)  1/165 (0.61%) 
Neuroendocrine carcinoma of the skin  1  0/164 (0.00%)  1/165 (0.61%) 
Rectosigmoid cancer  1  0/164 (0.00%)  1/165 (0.61%) 
Nervous system disorders     
Brain oedema  1  0/164 (0.00%)  1/165 (0.61%) 
Cerebrovascular accident  1  0/164 (0.00%)  1/165 (0.61%) 
Coma hepatic  1  1/164 (0.61%)  0/165 (0.00%) 
Ischaemic cerebral infarction  1  0/164 (0.00%)  1/165 (0.61%) 
Neuropathy peripheral  1  1/164 (0.61%)  0/165 (0.00%) 
Peripheral sensory neuropathy  1  0/164 (0.00%)  1/165 (0.61%) 
Radicular pain  1  1/164 (0.61%)  0/165 (0.00%) 
Renal and urinary disorders     
Calculus urinary  1  1/164 (0.61%)  0/165 (0.00%) 
Cystitis haemorrhagic  1  0/164 (0.00%)  1/165 (0.61%) 
Nephrolithiasis  1  1/164 (0.61%)  0/165 (0.00%) 
Renal failure  1  1/164 (0.61%)  0/165 (0.00%) 
Renal failure acute  1  0/164 (0.00%)  1/165 (0.61%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  1/164 (0.61%)  0/165 (0.00%) 
Acute respiratory failure  1  0/164 (0.00%)  1/165 (0.61%) 
Bronchospasm  1  1/164 (0.61%)  0/165 (0.00%) 
Chronic obstructive pulmonary disease  1  0/164 (0.00%)  1/165 (0.61%) 
Pulmonary oedema  1  0/164 (0.00%)  1/165 (0.61%) 
Skin and subcutaneous tissue disorders     
Dermatitis allergic  1  1/164 (0.61%)  0/165 (0.00%) 
Dermatitis exfoliative  1  1/164 (0.61%)  0/165 (0.00%) 
Pruritus  1  1/164 (0.61%)  0/165 (0.00%) 
Urticaria  1  2/164 (1.22%)  0/165 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  1/164 (0.61%)  0/165 (0.00%) 
Hypertension  1  1/164 (0.61%)  0/165 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Combination Arm (FluCAM) Fludarabine Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   160/164 (97.56%)   147/165 (89.09%) 
Blood and lymphatic system disorders     
Anaemia  1  36/164 (21.95%)  39/165 (23.64%) 
Autoimmune thrombocytopenia  1  0/164 (0.00%)  1/165 (0.61%) 
Eosinophilia  1  1/164 (0.61%)  3/165 (1.82%) 
Febrile neutropenia  1  1/164 (0.61%)  4/165 (2.42%) 
Granulocytopenia  1  3/164 (1.83%)  1/165 (0.61%) 
Haematotoxicity  1  0/164 (0.00%)  1/165 (0.61%) 
Idiopathic thrombocytopenic purpura  1  1/164 (0.61%)  0/165 (0.00%) 
Leukopenia  1  73/164 (44.51%)  25/165 (15.15%) 
Lymphopenia  1  35/164 (21.34%)  7/165 (4.24%) 
Neutropenia  1  82/164 (50.00%)  84/165 (50.91%) 
Pancytopenia  1  0/164 (0.00%)  1/165 (0.61%) 
Thrombocytopenia  1  44/164 (26.83%)  44/165 (26.67%) 
Cardiac disorders     
Angina pectoris  1  0/164 (0.00%)  2/165 (1.21%) 
Aortic valve calcification  1  1/164 (0.61%)  0/165 (0.00%) 
Aortic valve incompetence  1  1/164 (0.61%)  0/165 (0.00%) 
Arrhythmia  1  1/164 (0.61%)  0/165 (0.00%) 
Arteriosclerosis coronary artery  1  0/164 (0.00%)  1/165 (0.61%) 
Atrial fibrillation  1  1/164 (0.61%)  1/165 (0.61%) 
Cardiac failure  1  1/164 (0.61%)  0/165 (0.00%) 
Cardiomyopathy  1  0/164 (0.00%)  1/165 (0.61%) 
Diastolic dysfunction  1  1/164 (0.61%)  0/165 (0.00%) 
Hypertensive cardiomyopathy  1  1/164 (0.61%)  0/165 (0.00%) 
Hypertensive heart disease  1  1/164 (0.61%)  0/165 (0.00%) 
Left ventricular dysfunction  1  1/164 (0.61%)  0/165 (0.00%) 
Mitral valve incompetence  1  1/164 (0.61%)  0/165 (0.00%) 
Myocardial ischaemia  1  0/164 (0.00%)  1/165 (0.61%) 
Palpitations  1  1/164 (0.61%)  3/165 (1.82%) 
Pericardial effusion  1  2/164 (1.22%)  0/165 (0.00%) 
Sinus tachycardia  1  2/164 (1.22%)  0/165 (0.00%) 
Tachycardia  1  3/164 (1.83%)  0/165 (0.00%) 
Ventricular arrhythmia  1  1/164 (0.61%)  0/165 (0.00%) 
Ventricular extrasystoles  1  1/164 (0.61%)  0/165 (0.00%) 
Congenital, familial and genetic disorders     
Accessory spleen  1  1/164 (0.61%)  0/165 (0.00%) 
Kidney malformation  1  1/164 (0.61%)  0/165 (0.00%) 
Ear and labyrinth disorders     
Deafness neurosensory  1  1/164 (0.61%)  1/165 (0.61%) 
Hearing impaired  1  0/164 (0.00%)  1/165 (0.61%) 
Tinnitus  1  0/164 (0.00%)  2/165 (1.21%) 
Vertigo  1  2/164 (1.22%)  1/165 (0.61%) 
Endocrine disorders     
Goitre  1  2/164 (1.22%)  1/165 (0.61%) 
Hypothyroidism  1  1/164 (0.61%)  1/165 (0.61%) 
Eye disorders     
Cataract  1  0/164 (0.00%)  1/165 (0.61%) 
Conjunctival haemorrhage  1  0/164 (0.00%)  1/165 (0.61%) 
Conjunctivitis  1  1/164 (0.61%)  0/165 (0.00%) 
Conjunctivitis allergic  1  1/164 (0.61%)  0/165 (0.00%) 
Erythema of eyelid  1  0/164 (0.00%)  1/165 (0.61%) 
Lacrimation increased  1  1/164 (0.61%)  0/165 (0.00%) 
Retinopathy  1  0/164 (0.00%)  1/165 (0.61%) 
Retinopathy hypertensive  1  0/164 (0.00%)  1/165 (0.61%) 
Visual impairment  1  0/164 (0.00%)  1/165 (0.61%) 
Gastrointestinal disorders     
Abdominal discomfort  1  1/164 (0.61%)  1/165 (0.61%) 
Abdominal distension  1  0/164 (0.00%)  1/165 (0.61%) 
Abdominal pain  1  4/164 (2.44%)  3/165 (1.82%) 
Abdominal pain upper  1  0/164 (0.00%)  3/165 (1.82%) 
Aphthous stomatitis  1  1/164 (0.61%)  0/165 (0.00%) 
Ascites  1  1/164 (0.61%)  0/165 (0.00%) 
Cheilitis  1  1/164 (0.61%)  0/165 (0.00%) 
Colitis  1  1/164 (0.61%)  0/165 (0.00%) 
Constipation  1  6/164 (3.66%)  4/165 (2.42%) 
Diarrhoea  1  15/164 (9.15%)  11/165 (6.67%) 
Diverticulum intestinal  1  0/164 (0.00%)  1/165 (0.61%) 
Dry mouth  1  1/164 (0.61%)  1/165 (0.61%) 
Duodenal ulcer  1  0/164 (0.00%)  1/165 (0.61%) 
Duodenitis  1  0/164 (0.00%)  1/165 (0.61%) 
Dyspepsia  1  3/164 (1.83%)  3/165 (1.82%) 
Enterocolitis  1  1/164 (0.61%)  0/165 (0.00%) 
Erosive duodenitis  1  1/164 (0.61%)  0/165 (0.00%) 
Flatulence  1  2/164 (1.22%)  3/165 (1.82%) 
Gastric ulcer  1  1/164 (0.61%)  0/165 (0.00%) 
Gastritis  1  1/164 (0.61%)  0/165 (0.00%) 
Gastrooesophageal reflux disease  1  0/164 (0.00%)  1/165 (0.61%) 
Gingival bleeding  1  0/164 (0.00%)  1/165 (0.61%) 
Gingival pain  1  0/164 (0.00%)  1/165 (0.61%) 
Gingivitis ulcerative  1  0/164 (0.00%)  1/165 (0.61%) 
Haemorrhoids  1  3/164 (1.83%)  0/165 (0.00%) 
Lower gastrointestinal haemorrhage  1  0/164 (0.00%)  1/165 (0.61%) 
Nausea  1  20/164 (12.20%)  13/165 (7.88%) 
Pancreatic disorder  1  0/164 (0.00%)  1/165 (0.61%) 
Pancreatitis  1  3/164 (1.83%)  3/165 (1.82%) 
Pancreatitis acute  1  1/164 (0.61%)  0/165 (0.00%) 
Periodontitis  1  1/164 (0.61%)  0/165 (0.00%) 
Stomatitis  1  4/164 (2.44%)  0/165 (0.00%) 
Toothache  1  1/164 (0.61%)  1/165 (0.61%) 
Vomiting  1  15/164 (9.15%)  3/165 (1.82%) 
General disorders     
Asthenia  1  4/164 (2.44%)  6/165 (3.64%) 
Catheter site inflammation  1  1/164 (0.61%)  0/165 (0.00%) 
Chest discomfort  1  1/164 (0.61%)  0/165 (0.00%) 
Chills  1  49/164 (29.88%)  2/165 (1.21%) 
Face oedema  1  0/164 (0.00%)  1/165 (0.61%) 
Fatigue  1  10/164 (6.10%)  9/165 (5.45%) 
Generalised oedema  1  1/164 (0.61%)  0/165 (0.00%) 
Hyperpyrexia  1  2/164 (1.22%)  0/165 (0.00%) 
Hyperthermia  1  6/164 (3.66%)  0/165 (0.00%) 
Impaired healing  1  0/164 (0.00%)  1/165 (0.61%) 
Influenza like illness  1  2/164 (1.22%)  0/165 (0.00%) 
Infusion related reaction  1  20/164 (12.20%)  0/165 (0.00%) 
Injection site extravasation  1  1/164 (0.61%)  0/165 (0.00%) 
Injection site reaction  1  1/164 (0.61%)  0/165 (0.00%) 
Localised oedema  1  0/164 (0.00%)  3/165 (1.82%) 
Malaise  1  1/164 (0.61%)  1/165 (0.61%) 
Mucosal inflammation  1  1/164 (0.61%)  1/165 (0.61%) 
Non-cardiac chest pain  1  2/164 (1.22%)  0/165 (0.00%) 
Oedema  1  0/164 (0.00%)  1/165 (0.61%) 
Oedema peripheral  1  6/164 (3.66%)  4/165 (2.42%) 
Pyrexia  1  96/164 (58.54%)  14/165 (8.48%) 
Soft tissue inflammation  1  1/164 (0.61%)  0/165 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/164 (0.61%)  0/165 (0.00%) 
Cholecystitis chronic  1  5/164 (3.05%)  2/165 (1.21%) 
Cholelithiasis  1  0/164 (0.00%)  1/165 (0.61%) 
Hepatic cyst  1  1/164 (0.61%)  0/165 (0.00%) 
Hepatic steatosis  1  0/164 (0.00%)  1/165 (0.61%) 
Hepatitis chronic active  1  0/164 (0.00%)  1/165 (0.61%) 
Hepatitis toxic  1  1/164 (0.61%)  1/165 (0.61%) 
Hepatomegaly  1  1/164 (0.61%)  0/165 (0.00%) 
Hyperbilirubinaemia  1  4/164 (2.44%)  0/165 (0.00%) 
Liver disorder  1  0/164 (0.00%)  1/165 (0.61%) 
Immune system disorders     
Allergy to arthropod bite  1  1/164 (0.61%)  0/165 (0.00%) 
Cytokine release syndrome  1  7/164 (4.27%)  0/165 (0.00%) 
Drug hypersensitivity  1  1/164 (0.61%)  0/165 (0.00%) 
Hypersensitivity  1  5/164 (3.05%)  1/165 (0.61%) 
Mycotic allergy  1  1/164 (0.61%)  0/165 (0.00%) 
Seasonal allergy  1  2/164 (1.22%)  0/165 (0.00%) 
Infections and infestations     
Acute sinusitis  1  0/164 (0.00%)  1/165 (0.61%) 
Ascariasis  1  1/164 (0.61%)  0/165 (0.00%) 
Bronchitis  1  15/164 (9.15%)  5/165 (3.03%) 
Bronchopneumonia  1  2/164 (1.22%)  0/165 (0.00%) 
Bullous impetigo  1  0/164 (0.00%)  1/165 (0.61%) 
Candidiasis  1  1/164 (0.61%)  0/165 (0.00%) 
Conjunctivitis infective  1  0/164 (0.00%)  1/165 (0.61%) 
Cystitis  1  1/164 (0.61%)  1/165 (0.61%) 
Cytomegalovirus infection  1  2/164 (1.22%)  0/165 (0.00%) 
Folliculitis  1  1/164 (0.61%)  0/165 (0.00%) 
Herpes simplex  1  2/164 (1.22%)  1/165 (0.61%) 
Herpes zoster  1  4/164 (2.44%)  3/165 (1.82%) 
Infection  1  2/164 (1.22%)  0/165 (0.00%) 
Influenza  1  2/164 (1.22%)  1/165 (0.61%) 
Klebsiella bacteraemia  1  0/164 (0.00%)  1/165 (0.61%) 
Laryngitis  1  1/164 (0.61%)  0/165 (0.00%) 
Nasopharyngitis  1  7/164 (4.27%)  8/165 (4.85%) 
Neutropenic infection  1  2/164 (1.22%)  1/165 (0.61%) 
Oral fungal infection  1  1/164 (0.61%)  2/165 (1.21%) 
Oral herpes  1  3/164 (1.83%)  3/165 (1.82%) 
Otitis media  1  1/164 (0.61%)  0/165 (0.00%) 
Perirectal abscess  1  0/164 (0.00%)  1/165 (0.61%) 
Pharyngitis  1  6/164 (3.66%)  5/165 (3.03%) 
Pneumonia  1  6/164 (3.66%)  3/165 (1.82%) 
Pulpitis dental  1  0/164 (0.00%)  1/165 (0.61%) 
Respiratory tract infection  1  4/164 (2.44%)  5/165 (3.03%) 
Respiratory tract infection viral  1  4/164 (2.44%)  2/165 (1.21%) 
Rhinitis  1  3/164 (1.83%)  3/165 (1.82%) 
Sinusitis  1  1/164 (0.61%)  3/165 (1.82%) 
Skin candida  1  0/164 (0.00%)  1/165 (0.61%) 
Staphylococcal infection  1  0/164 (0.00%)  1/165 (0.61%) 
Tinea versicolour  1  1/164 (0.61%)  0/165 (0.00%) 
Tonsillitis  1  1/164 (0.61%)  3/165 (1.82%) 
Tooth infection  1  0/164 (0.00%)  1/165 (0.61%) 
Tracheitis  1  2/164 (1.22%)  1/165 (0.61%) 
Upper respiratory tract infection  1  3/164 (1.83%)  3/165 (1.82%) 
Urinary tract infection  1  3/164 (1.83%)  1/165 (0.61%) 
Urinary tract infection pseudomonal  1  0/164 (0.00%)  1/165 (0.61%) 
Viral infection  1  0/164 (0.00%)  1/165 (0.61%) 
Viral upper respiratory tract infection  1  3/164 (1.83%)  1/165 (0.61%) 
Injury, poisoning and procedural complications     
Arthropod bite  1  0/164 (0.00%)  1/165 (0.61%) 
Injury  1  0/164 (0.00%)  1/165 (0.61%) 
Joint sprain  1  1/164 (0.61%)  0/165 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  6/164 (3.66%)  5/165 (3.03%) 
Aspartate aminotransferase increased  1  2/164 (1.22%)  2/165 (1.21%) 
Beta 2 microglobulin decreased  1  1/164 (0.61%)  0/165 (0.00%) 
Blood albumin decreased  1  0/164 (0.00%)  1/165 (0.61%) 
Blood alkaline phosphatase increased  1  0/164 (0.00%)  1/165 (0.61%) 
Blood bilirubin increased  1  2/164 (1.22%)  1/165 (0.61%) 
Blood creatinine increased  1  4/164 (2.44%)  3/165 (1.82%) 
Blood lactate dehydrogenase increased  1  3/164 (1.83%)  0/165 (0.00%) 
Body temperature increased  1  2/164 (1.22%)  1/165 (0.61%) 
Breath sounds abnormal  1  0/164 (0.00%)  1/165 (0.61%) 
Cd4 lymphocytes decreased  1  4/164 (2.44%)  2/165 (1.21%) 
Creatinine renal clearance decreased  1  5/164 (3.05%)  5/165 (3.03%) 
Cytomegalovirus test positive  1  19/164 (11.59%)  1/165 (0.61%) 
Gamma-glutamyltransferase increased  1  1/164 (0.61%)  2/165 (1.21%) 
Haemoglobin decreased  1  4/164 (2.44%)  5/165 (3.03%) 
Hepatic enzyme increased  1  0/164 (0.00%)  1/165 (0.61%) 
Lymphocyte count decreased  1  2/164 (1.22%)  1/165 (0.61%) 
Neutrophil count decreased  1  6/164 (3.66%)  7/165 (4.24%) 
Neutrophil pelger-huet anomaly present  1  1/164 (0.61%)  0/165 (0.00%) 
Platelet count decreased  1  6/164 (3.66%)  10/165 (6.06%) 
Urine uric acid increased  1  1/164 (0.61%)  0/165 (0.00%) 
Weight decreased  1  2/164 (1.22%)  2/165 (1.21%) 
Weight increased  1  1/164 (0.61%)  2/165 (1.21%) 
White blood cell count decreased  1  7/164 (4.27%)  3/165 (1.82%) 
Metabolism and nutrition disorders     
Decreased appetite  1  2/164 (1.22%)  1/165 (0.61%) 
Dehydration  1  1/164 (0.61%)  0/165 (0.00%) 
Diabetes mellitus  1  2/164 (1.22%)  0/165 (0.00%) 
Fluid retention  1  2/164 (1.22%)  0/165 (0.00%) 
Gout  1  1/164 (0.61%)  0/165 (0.00%) 
Hyperglycaemia  1  3/164 (1.83%)  2/165 (1.21%) 
Hyperkalaemia  1  0/164 (0.00%)  1/165 (0.61%) 
Hypernatraemia  1  0/164 (0.00%)  1/165 (0.61%) 
Hyperphosphataemia  1  0/164 (0.00%)  1/165 (0.61%) 
Hyperproteinaemia  1  1/164 (0.61%)  0/165 (0.00%) 
Hyperuricaemia  1  1/164 (0.61%)  4/165 (2.42%) 
Hypoalbuminaemia  1  4/164 (2.44%)  1/165 (0.61%) 
Hypokalaemia  1  4/164 (2.44%)  0/165 (0.00%) 
Hypophosphataemia  1  1/164 (0.61%)  1/165 (0.61%) 
Hypoproteinaemia  1  1/164 (0.61%)  1/165 (0.61%) 
Tumour lysis syndrome  1  0/164 (0.00%)  2/165 (1.21%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/164 (1.83%)  2/165 (1.21%) 
Arthritis  1  0/164 (0.00%)  1/165 (0.61%) 
Arthritis reactive  1  0/164 (0.00%)  1/165 (0.61%) 
Back pain  1  4/164 (2.44%)  3/165 (1.82%) 
Bone pain  1  9/164 (5.49%)  0/165 (0.00%) 
Gouty arthritis  1  0/164 (0.00%)  1/165 (0.61%) 
Groin pain  1  0/164 (0.00%)  1/165 (0.61%) 
Mastication disorder  1  1/164 (0.61%)  0/165 (0.00%) 
Musculoskeletal pain  1  1/164 (0.61%)  2/165 (1.21%) 
Myalgia  1  2/164 (1.22%)  1/165 (0.61%) 
Myositis  1  1/164 (0.61%)  0/165 (0.00%) 
Osteoarthritis  1  0/164 (0.00%)  1/165 (0.61%) 
Osteochondrosis  1  3/164 (1.83%)  2/165 (1.21%) 
Osteonecrosis of jaw  1  1/164 (0.61%)  0/165 (0.00%) 
Pain in extremity  1  2/164 (1.22%)  2/165 (1.21%) 
Rheumatoid arthritis  1  1/164 (0.61%)  0/165 (0.00%) 
Rotator cuff syndrome  1  0/164 (0.00%)  1/165 (0.61%) 
Scoliosis  1  0/164 (0.00%)  1/165 (0.61%) 
Spinal deformity  1  1/164 (0.61%)  0/165 (0.00%) 
Spinal osteoarthritis  1  1/164 (0.61%)  0/165 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma  1  0/164 (0.00%)  1/165 (0.61%) 
Benign lung neoplasm  1  1/164 (0.61%)  0/165 (0.00%) 
Gastrointestinal carcinoma  1  0/164 (0.00%)  1/165 (0.61%) 
Lipoma  1  1/164 (0.61%)  1/165 (0.61%) 
Malignant pleural effusion  1  1/164 (0.61%)  1/165 (0.61%) 
Metastases to liver  1  1/164 (0.61%)  0/165 (0.00%) 
Paraneoplastic pemphigus  1  0/164 (0.00%)  1/165 (0.61%) 
Paraproteinaemia  1  1/164 (0.61%)  0/165 (0.00%) 
Seborrhoeic keratosis  1  1/164 (0.61%)  1/165 (0.61%) 
Skin papilloma  1  1/164 (0.61%)  0/165 (0.00%) 
Nervous system disorders     
Cognitive disorder  1  1/164 (0.61%)  0/165 (0.00%) 
Dizziness  1  4/164 (2.44%)  5/165 (3.03%) 
Dysaesthesia  1  0/164 (0.00%)  1/165 (0.61%) 
Dysgeusia  1  1/164 (0.61%)  1/165 (0.61%) 
Facial neuralgia  1  1/164 (0.61%)  0/165 (0.00%) 
Headache  1  14/164 (8.54%)  4/165 (2.42%) 
Hypoaesthesia  1  0/164 (0.00%)  2/165 (1.21%) 
Memory impairment  1  1/164 (0.61%)  0/165 (0.00%) 
Neuralgia  1  0/164 (0.00%)  1/165 (0.61%) 
Neuropathy peripheral  1  0/164 (0.00%)  2/165 (1.21%) 
Paraesthesia  1  0/164 (0.00%)  2/165 (1.21%) 
Peripheral sensory neuropathy  1  1/164 (0.61%)  3/165 (1.82%) 
Post herpetic neuralgia  1  1/164 (0.61%)  0/165 (0.00%) 
Radicular pain  1  1/164 (0.61%)  0/165 (0.00%) 
Sciatica  1  0/164 (0.00%)  1/165 (0.61%) 
Somnolence  1  0/164 (0.00%)  1/165 (0.61%) 
Sphenopalatine neuralgia  1  1/164 (0.61%)  0/165 (0.00%) 
Syncope  1  1/164 (0.61%)  0/165 (0.00%) 
Toxic encephalopathy  1  0/164 (0.00%)  2/165 (1.21%) 
Tremor  1  1/164 (0.61%)  0/165 (0.00%) 
Psychiatric disorders     
Agitation  1  1/164 (0.61%)  1/165 (0.61%) 
Anxiety  1  1/164 (0.61%)  0/165 (0.00%) 
Confusional state  1  1/164 (0.61%)  0/165 (0.00%) 
Depression  1  2/164 (1.22%)  1/165 (0.61%) 
Disorientation  1  0/164 (0.00%)  1/165 (0.61%) 
Hallucination  1  1/164 (0.61%)  0/165 (0.00%) 
Insomnia  1  5/164 (3.05%)  2/165 (1.21%) 
Sleep disorder  1  0/164 (0.00%)  1/165 (0.61%) 
Renal and urinary disorders     
Calculus urinary  1  1/164 (0.61%)  0/165 (0.00%) 
Chromaturia  1  1/164 (0.61%)  0/165 (0.00%) 
Crystalluria  1  1/164 (0.61%)  0/165 (0.00%) 
Cystitis haemorrhagic  1  1/164 (0.61%)  0/165 (0.00%) 
Dysuria  1  0/164 (0.00%)  1/165 (0.61%) 
Leukocyturia  1  1/164 (0.61%)  0/165 (0.00%) 
Nephrolithiasis  1  0/164 (0.00%)  1/165 (0.61%) 
Nephroptosis  1  2/164 (1.22%)  0/165 (0.00%) 
Pollakiuria  1  5/164 (3.05%)  3/165 (1.82%) 
Renal failure  1  1/164 (0.61%)  0/165 (0.00%) 
Renal failure acute  1  0/164 (0.00%)  1/165 (0.61%) 
Renal impairment  1  2/164 (1.22%)  0/165 (0.00%) 
Urinary retention  1  1/164 (0.61%)  0/165 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/164 (0.61%)  2/165 (1.21%) 
Calculus prostatic  1  0/164 (0.00%)  1/165 (0.61%) 
Metrorrhagia  1  1/164 (0.61%)  0/165 (0.00%) 
Vaginal haemorrhage  1  0/164 (0.00%)  1/165 (0.61%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/164 (0.00%)  1/165 (0.61%) 
Bronchitis chronic  1  1/164 (0.61%)  0/165 (0.00%) 
Bronchospasm  1  8/164 (4.88%)  0/165 (0.00%) 
Cough  1  13/164 (7.93%)  8/165 (4.85%) 
Dysphonia  1  1/164 (0.61%)  0/165 (0.00%) 
Dyspnoea  1  5/164 (3.05%)  1/165 (0.61%) 
Epistaxis  1  1/164 (0.61%)  2/165 (1.21%) 
Haemoptysis  1  1/164 (0.61%)  0/165 (0.00%) 
Hiccups  1  3/164 (1.83%)  0/165 (0.00%) 
Laryngeal polyp  1  1/164 (0.61%)  0/165 (0.00%) 
Lung infiltration  1  1/164 (0.61%)  0/165 (0.00%) 
Nasal dryness  1  1/164 (0.61%)  0/165 (0.00%) 
Obstructive airways disorder  1  0/164 (0.00%)  1/165 (0.61%) 
Oropharyngeal pain  1  0/164 (0.00%)  2/165 (1.21%) 
Pleural effusion  1  3/164 (1.83%)  0/165 (0.00%) 
Pleurisy  1  1/164 (0.61%)  0/165 (0.00%) 
Pneumonitis  1  1/164 (0.61%)  0/165 (0.00%) 
Pulmonary congestion  1  1/164 (0.61%)  0/165 (0.00%) 
Respiratory alkalosis  1  0/164 (0.00%)  1/165 (0.61%) 
Respiratory disorder  1  1/164 (0.61%)  1/165 (0.61%) 
Respiratory failure  1  0/164 (0.00%)  1/165 (0.61%) 
Sinus congestion  1  1/164 (0.61%)  0/165 (0.00%) 
Throat irritation  1  1/164 (0.61%)  0/165 (0.00%) 
Wheezing  1  0/164 (0.00%)  1/165 (0.61%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  1/164 (0.61%)  0/165 (0.00%) 
Angioedema  1  0/164 (0.00%)  1/165 (0.61%) 
Dermatitis  1  1/164 (0.61%)  0/165 (0.00%) 
Dermatitis allergic  1  13/164 (7.93%)  4/165 (2.42%) 
Drug eruption  1  6/164 (3.66%)  0/165 (0.00%) 
Dry skin  1  1/164 (0.61%)  0/165 (0.00%) 
Eczema  1  1/164 (0.61%)  1/165 (0.61%) 
Erythema  1  1/164 (0.61%)  3/165 (1.82%) 
Exfoliative rash  1  1/164 (0.61%)  0/165 (0.00%) 
Hyperhidrosis  1  3/164 (1.83%)  3/165 (1.82%) 
Hyperkeratosis  1  1/164 (0.61%)  0/165 (0.00%) 
Night sweats  1  2/164 (1.22%)  0/165 (0.00%) 
Petechiae  1  0/164 (0.00%)  1/165 (0.61%) 
Pruritus  1  13/164 (7.93%)  4/165 (2.42%) 
Pruritus allergic  1  3/164 (1.83%)  1/165 (0.61%) 
Pruritus generalised  1  1/164 (0.61%)  0/165 (0.00%) 
Rash  1  25/164 (15.24%)  5/165 (3.03%) 
Rash erythematous  1  1/164 (0.61%)  0/165 (0.00%) 
Rash generalised  1  0/164 (0.00%)  1/165 (0.61%) 
Rash macular  1  1/164 (0.61%)  0/165 (0.00%) 
Rash maculo-papular  1  1/164 (0.61%)  0/165 (0.00%) 
Rash papular  1  1/164 (0.61%)  0/165 (0.00%) 
Seborrhoeic dermatitis  1  1/164 (0.61%)  0/165 (0.00%) 
Skin exfoliation  1  0/164 (0.00%)  2/165 (1.21%) 
Skin hyperpigmentation  1  0/164 (0.00%)  2/165 (1.21%) 
Skin lesion  1  0/164 (0.00%)  1/165 (0.61%) 
Skin swelling  1  0/164 (0.00%)  1/165 (0.61%) 
Skin ulcer  1  0/164 (0.00%)  1/165 (0.61%) 
Swelling face  1  0/164 (0.00%)  1/165 (0.61%) 
Urticaria  1  22/164 (13.41%)  4/165 (2.42%) 
Urticaria vesiculosa  1  1/164 (0.61%)  0/165 (0.00%) 
Vascular disorders     
Arteriosclerosis obliterans  1  1/164 (0.61%)  0/165 (0.00%) 
Deep vein thrombosis  1  2/164 (1.22%)  0/165 (0.00%) 
Flushing  1  1/164 (0.61%)  0/165 (0.00%) 
Hot flush  1  1/164 (0.61%)  0/165 (0.00%) 
Hypertension  1  11/164 (6.71%)  6/165 (3.64%) 
Hypertensive crisis  1  1/164 (0.61%)  0/165 (0.00%) 
Hypotension  1  3/164 (1.83%)  2/165 (1.21%) 
Phlebitis  1  2/164 (1.22%)  0/165 (0.00%) 
Systolic hypertension  1  1/164 (0.61%)  1/165 (0.61%) 
Temporal arteritis  1  1/164 (0.61%)  0/165 (0.00%) 
Varicose vein  1  1/164 (0.61%)  0/165 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In multi-site studies, PI can publish after an independent multi-investigator publication (in which the PI can participate) or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.
Results Point of Contact
Name/Title: Genzyme Medical Information
Organization: Genzyme Corporation
Phone: 800-745-4447
Publications of Results:
Engert A, et al. Overall Survival Advantage and Acceptable Safety Profile with Fludarabine in Combination with Alemtuzumab (FluCam) in Previously Treated Patients with Advanced Stage Chronic Lymphocytic Leukemia. Poster Presentation at American Society of Hematology 10 December 2010; Blood (ASH Annual Meeting Abstracts), Nov 2010;116:919. http://ash.confex.com/ash/2010/webprogram/Paper31687.html
Engert A, et al. Improved Progression-free Survival (PFS) of Alemtuzumab (Campath®, MabCampath®) plus Fludarabine (Fludara®) versus Fludarabine Alone as Second-line Treatment of Patients with B-Cell Chronic Lymphocytic Leukemia: Preliminary Results from a Phase III Randomized Trial. 51st ASH Annual Meeting. Blood 2009;114. Abstract 537. http://ash.confex.com/ash/2009/webprogram/Paper21929.html
Engert A, et al. Fludarabine (FLU) plus Alemtuzumab (FluCAM) Improves Progression Free Survival versus Fludarabine in Previously Treated Chronic Lymphocytic Leukemia and Demonstrates Activity in High Risk Patients. Poster Presentation at European Hematology Association 12 June 2010. Abstract 0768. http://www.eventure-online.com/eventure/publicAbstractView.do?id=136964&congressId=3446
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00086580     History of Changes
Other Study ID Numbers: CAM314
2004-000149-39 ( EudraCT Number )
First Submitted: July 6, 2004
First Posted: July 8, 2004
Results First Submitted: June 13, 2011
Results First Posted: August 11, 2011
Last Update Posted: March 13, 2014