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Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma) (AUGMENT)

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ClinicalTrials.gov Identifier: NCT01938001
Recruitment Status : Active, not recruiting
First Posted : September 10, 2013
Results First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lymphoma, Non-Hodgkin
Interventions Drug: Rituximab
Drug: Lenalidomide
Drug: Placebo
Enrollment 358
Recruitment Details 358 participants were randomized into the study from sites located in Belgium, Brazil, China, Czech Republic, France, Germany, Israel, Italy, Japan, Poland, Portugal, Russia, Spain, Turkey and the United States.
Pre-assignment Details

Participants were stratified by the following:

  • previous rituximab treatment (yes, no)
  • time since last anti-lymphoma therapy (≤ 2, > 2 years)
  • disease histology (follicular or marginal zone lymphoma)
Arm/Group Title Rituximab Plus Lenalidomide (R^2) Rituximab Plus Placebo
Hide Arm/Group Description Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days. Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Period Title: Overall Study
Started 178 180
Participants Received Treatment 176 180
Completed Treatment [1] 124 110
Completed [2] 135 133
Not Completed 43 47
Reason Not Completed
Withdrawal by Subject             25             17
Non-compliant             1             0
Participant Moved             0             1
Lost to Follow-up             1             3
Death             16             26
[1]
Completed = participants who fully completed 12 cycles of treatment
[2]
Participants ongoing at data cut-off date
Arm/Group Title Rituximab Plus Lenalidomide (R^2) Rituximab Plus Placebo Total
Hide Arm/Group Description Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days. Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles. Total of all reporting groups
Overall Number of Baseline Participants 178 180 358
Hide Baseline Analysis Population Description
The intent to treat (ITT) population was defined as all participants who were randomized into the trial, regardless of whether they received investigational product (IP) or not.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 178 participants 180 participants 358 participants
62.30  (11.227) 61.48  (11.160) 61.89  (11.186)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants 180 participants 358 participants
Female
103
  57.9%
83
  46.1%
186
  52.0%
Male
75
  42.1%
97
  53.9%
172
  48.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants 180 participants 358 participants
White
118
  66.3%
115
  63.9%
233
  65.1%
Other Races
54
  30.3%
64
  35.6%
118
  33.0%
Not Collected or Reported
6
   3.4%
1
   0.6%
7
   2.0%
Ann Arbor Stage at Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants 180 participants 358 participants
Stage I
15
   8.4%
18
  10.0%
33
   9.2%
Stage II
26
  14.6%
38
  21.1%
64
  17.9%
Stage III
73
  41.0%
65
  36.1%
138
  38.5%
Stage IV
64
  36.0%
59
  32.8%
123
  34.4%
[1]
Measure Description:

Ann Arbor staging is the staging system for lymphomas. The stage depends on both the place where the malignant tissue is located and on systemic symptoms ("B symptoms": night sweats, weight loss of >10% or fevers). The Stages include:

I: Involvement of a single lymph node (LN) region II: Involvement of 2 or more LN on the same side of the diaphragm III: Involvement of LN regions on both sides of the diaphragm IV: Multifocal involvement of ≥ 1 extralymphatic sites with or without associated LN involvement or isolated extralymphatic organ involvement with distant (non regional) nodal involvement

Follicular Lymphoma International Prognostic Index (FLIPI) category   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants 180 participants 358 participants
Low (0,1)
52
  29.2%
67
  37.2%
119
  33.2%
Intermediate (2)
55
  30.9%
58
  32.2%
113
  31.6%
High (≥3)
69
  38.8%
54
  30.0%
123
  34.4%
Missing
2
   1.1%
1
   0.6%
3
   0.8%
[1]
Measure Description: A FLIPI score of 0 to 1 is considered “low risk” with a 10 year overall survival of 70%. A score of 2 is considered “intermediate risk” with a 10 year overall survival of 50%. Finally, a score of ≥ 3 is considered “high risk” with a 10 year overall survival of 35%.
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants 180 participants 358 participants
0 (Fully Active)
116
  65.2%
128
  71.1%
244
  68.2%
1 (Restrictive but ambulatory)
60
  33.7%
50
  27.8%
110
  30.7%
2 (Ambulatory but unable to work)
2
   1.1%
2
   1.1%
4
   1.1%
3 (Limited self-care)
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: ECOG Performance Status is used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living activities of the patient and determine appropriate treatment and prognosis.
Histology   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants 180 participants 358 participants
Follicular Lymphoma (FL)
147
  82.6%
148
  82.2%
295
  82.4%
Marginal Zone Lymphoma (MZL)
31
  17.4%
32
  17.8%
63
  17.6%
[1]
Measure Description: Histology refers to the study of the anatomy of cells and tissues at the microscopic level.
Histology By Central Pathology Review   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants 180 participants 358 participants
Follicular Lymphoma
129
  72.5%
137
  76.1%
266
  74.3%
Marginal Zone Lymphoma
26
  14.6%
27
  15.0%
53
  14.8%
Unclear/ Other Histology
5
   2.8%
3
   1.7%
8
   2.2%
Inadequate Sample
13
   7.3%
11
   6.1%
24
   6.7%
No Central Pathology Review
5
   2.8%
2
   1.1%
7
   2.0%
[1]
Measure Description: Histology refers to the study of the anatomy of cells and tissues at the microscopic level.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants 180 participants 358 participants
United States
23
  12.9%
17
   9.4%
40
  11.2%
Europe
81
  45.5%
84
  46.7%
165
  46.1%
Asia Pacific and Brazil
74
  41.6%
79
  43.9%
153
  42.7%
1.Primary Outcome
Title Kaplan Meier Estimate of Progression Free Survival Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC)
Hide Description Progression-free survival (PFS) was defined as the time from date of randomization into the study to the first observation of documented disease progression or death due to any cause, whichever occurred first. PFS was based on the data from the IRC review using the modified 2007 International Working Group Response Criteria (IWGRC) using FDA censoring rules.
Time Frame From randomization of study drug up to disease progression or death, which occurred first; up to the data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.
Arm/Group Title Rituximab Plus Lenalidomide (R^2) Rituximab Plus Placebo
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed 178 180
Median (95% Confidence Interval)
Unit of Measure: months
39.4 [1] 
(22.9 to NA)
14.1
(11.4 to 16.7)
[1]
NA =Not enough events had occurred at the time of the data cut-off date
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Log Rank
Comments Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
0.34 to 0.62
Estimation Comments Hazard ratio and its confidence interval (CI) were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.
2.Secondary Outcome
Title Durable Complete Response Rate (DCCR) as Assessed by the IRC According to the 2007 IWGRC
Hide Description DCCR was defined as the percentage of participants with a best response of complete response (CR) that lasted no less than one year (≥ 48 weeks) during the study prior to administration of new anti-lymphoma therapy. A CR is defined as a complete disappearance of any disease-related symptoms and normalization of biochemical abnormalities.
Time Frame From first dose of investigational product (IP) to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomiade arm and 11.04 months in the rituximab/placebo arm
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.
Arm/Group Title Rituximab Plus Lenalidomide (R^2) Rituximab Plus Placebo
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed 178 180
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
25.3
(19.1 to 32.3)
11.1
(6.9 to 16.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).
3.Secondary Outcome
Title Kaplan-Meier Estimate of Overall Survival (OS)
Hide Description Overall survival was defined as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Time Frame From the date of randomization to the cut-off date of 22 June 2018; The overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population is defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.
Arm/Group Title Rituximab Plus Lenalidomide (R^2) Rituximab Plus Placebo
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed 178 180
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA = not estimable because the median for OS had not been reached at the date of the data cut-off.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
Comments Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
0.33 to 1.13
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With an Objective Response as Assessed by the IRC According to the 2007 IWGRC
Hide Description Percentage of participants with an objective response is defined as having a response of at least a PR during the study without administration of new anti-lymphoma therapy. A complete response = a complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities; a partial response (PR) = 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD.
Time Frame From date of first dose to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.
Arm/Group Title Rituximab Plus Lenalidomide (R^2) Rituximab Plus Placebo
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed 178 180
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
77.5
(70.7 to 83.4)
53.3
(45.8 to 60.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).
5.Secondary Outcome
Title Percentage of Participants With a Best Response of Complete Response as Assessed by the IRC According to the 2007 IWGRC
Hide Description Percentage of participants with a best response of at CR during the study without administration of new anti-lymphoma therapy. A CR = Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.
Time Frame From date of first dose up to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.
Arm/Group Title Rituximab Plus Lenalidomide (R^2) Rituximab Plus Placebo
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed 178 180
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
33.7
(26.8 to 41.2)
18.3
(13.0 to 24.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0010
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).
6.Secondary Outcome
Title Kaplan-Meier Estimate of Duration of Objective Response as Assessed by the IRC According to the 2007 IWGRC
Hide Description Duration of response (DOR) was defined as the time from initial response (at least PR) until documented progressive disease (PD) or death. Participants who had not progressed at the time of analysis were censored at the last assessment date that the participant was known to be progression free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participants was known to be progression free.
Time Frame From randomization up to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved an objective response in the ITT population.
Arm/Group Title Rituximab Plus Lenalidomide (R^2) Rituximab Plus Placebo
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed 138 96
Median (95% Confidence Interval)
Unit of Measure: months
36.6 [1] 
(22.9 to NA)
21.7
(12.8 to 27.6)
[1]
Not estimable as not enough events had occurred at the time of the data cut-off date
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0015
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.36 to 0.79
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Kaplan-Meier Estimate of Duration of Complete Response (DOCR) as Assessed by the IRC According to the 2007 IWGRC
Hide Description DOCR was defined as the time from initial CR until documented PD or death. Participants who had not progressed at the time of analysis were censored at the last assessment date that the participant was known to be progression free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participants was known to be progression free.
Time Frame From randomization up to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a complete response in the ITT population.
Arm/Group Title Rituximab Plus Lenalidomide (R^2) Rituximab Plus Placebo
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed 60 33
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(25.3 to NA)
NA [1] 
(13.8 to NA)
[1]
Not enough events had occurred at the time of the data cut-off date
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2993
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.32 to 1.43
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Kaplan Meier Estimate of Event Free Survival as Assessed by the IRC According to the 2007 IWGRC
Hide Description Event-free survival (EFS) was defined as the time from date of randomization to date of first documented progression, relapse, institution of new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy) or death from any cause. Responding participants and those who were lost to follow up were censored at their last tumor assessment date.
Time Frame From date of randomization to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.
Arm/Group Title Rituximab Plus Lenalidomide (R^2) Rituximab Plus Placebo
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed 178 180
Median (95% Confidence Interval)
Unit of Measure: months
27.6 [1] 
(22.1 to NA)
13.9
(11.4 to 16.7)
[1]
Not enough events had occurred at the time of the data cut-off date
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Stratified Log-Rank Test
Comments Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.51
Confidence Interval (2-Sided) 95%
0.38 to 0.67
Estimation Comments Hazard ratio and its CI were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.
9.Secondary Outcome
Title Kaplan Meier Estimate of Time to Next Anti-Lymphoma Treatment (TTNLT)
Hide Description Time to next anti-lymphoma treatment (TTNLT) was defined as the time from date of randomization to date of first documented administration of a new anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy or immunotherapy). The time to the next anti-lymphoma treatment was of special interest to the study.
Time Frame From randomization to data cut off of 22 Jun 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.
Arm/Group Title Rituximab Plus Lenalidomide (R^2) Rituximab Plus Placebo
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed 178 180
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
32.2 [2] 
(23.2 to NA)
[1]
Not estmable due to the low number of events at the time of the data cut-off date.
[2]
The upper limit was not estmable due to the low number of events at the time of the data cut-off date.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Stratified Log Rank Test
Comments Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
0.38 to 0.78
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Hide Description

TEAEs include AEs that started or worsened between the date of the first dose and 28 days after the date of the last dose. A serious adverse event (SAE) is any:

  • Death;
  • Life-threatening event;
  • Any inpatient hospitalization or prolongation of existing hospitalization;
  • Persistent or significant disability or incapacity;
  • Congenital anomaly or birth defect;
  • Any other important medical event The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.03) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death
Time Frame From the first dose of study drug up to 28 days after the last dose of IP and those SAEs made known at any time; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication.
Arm/Group Title Rituximab Plus Lenalidomide (R^2) Rituximab Plus Placebo
Hide Arm/Group Description:
Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed 176 180
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
174
  98.9%
173
  96.1%
Any TEAE Related To Lenalidomide/Placebo (LEN/PBO)
159
  90.3%
118
  65.6%
Any TEAE Related To Rituximab (RIT)
132
  75.0%
105
  58.3%
Any SAE
45
  25.6%
25
  13.9%
Any SAE Related to LEN/PBO
23
  13.1%
8
   4.4%
Any SAE Related to RIT
13
   7.4%
3
   1.7%
Any CTCAE Grade (GR) 3/4 TEAE
121
  68.8%
58
  32.2%
Any CTCAE GR 3/4 TEAE Related to LEN/PBO
101
  57.4%
38
  21.1%
Any CTCAE GR 3/4 TEAE Related to RIT
57
  32.4%
19
  10.6%
Any GR 5 TEAE
2
   1.1%
2
   1.1%
Any TEAE Leading To Dose Reduction LEN/PBO
46
  26.1%
6
   3.3%
Any TEAE Leading To Dose Interruption LEN/PBO
112
  63.6%
47
  26.1%
Any TEAE Leading To Dose Interruption RIT
60
  34.1%
37
  20.6%
Any TEAE Leading To Discontinuation of LEN/PBO
15
   8.5%
9
   5.0%
Any TEAE Leading To Discontinuation of RIT
6
   3.4%
2
   1.1%
Time Frame From the date of the first dose of study drug up to 28 days after the last dose of IP and those SAEs made known to the investigator at any time thereafter that are suspected of being related to IP. AEs collected and monitored up to the data cut off date of 22 June 2018.
Adverse Event Reporting Description The median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm
 
Arm/Group Title Rituximab and Lenalidomide Rituximab and Placebo
Hide Arm/Group Description Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days. Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
All-Cause Mortality
Rituximab and Lenalidomide Rituximab and Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   16/176 (9.09%)   26/180 (14.44%) 
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab and Lenalidomide Rituximab and Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   45/176 (25.57%)   25/180 (13.89%) 
Blood and lymphatic system disorders     
Anaemia  1  2/176 (1.14%)  0/180 (0.00%) 
Febrile neutropenia  1  5/176 (2.84%)  0/180 (0.00%) 
Leukopenia  1  1/176 (0.57%)  0/180 (0.00%) 
Neutropenia  1  3/176 (1.70%)  0/180 (0.00%) 
Pancytopenia  1  1/176 (0.57%)  0/180 (0.00%) 
Cardiac disorders     
Angina pectoris  1  1/176 (0.57%)  0/180 (0.00%) 
Arrhythmia  1  1/176 (0.57%)  0/180 (0.00%) 
Atrial fibrillation  1  1/176 (0.57%)  2/180 (1.11%) 
Atrial flutter  1  0/176 (0.00%)  1/180 (0.56%) 
Cardiopulmonary failure  1  1/176 (0.57%)  0/180 (0.00%) 
Myocardial infarction  1  0/176 (0.00%)  1/180 (0.56%) 
Supraventricular tachycardia  1  2/176 (1.14%)  0/180 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/176 (0.57%)  0/180 (0.00%) 
Eye disorders     
Retinal detachment  1  0/176 (0.00%)  1/180 (0.56%) 
Gastrointestinal disorders     
Diarrhoea  1  1/176 (0.57%)  0/180 (0.00%) 
Faecaloma  1  1/176 (0.57%)  0/180 (0.00%) 
Haemorrhagic erosive gastritis  1  0/176 (0.00%)  1/180 (0.56%) 
Haemorrhoids  1  0/176 (0.00%)  1/180 (0.56%) 
Volvulus  1  1/176 (0.57%)  0/180 (0.00%) 
General disorders     
Asthenia  1  0/176 (0.00%)  1/180 (0.56%) 
Fatigue  1  0/176 (0.00%)  1/180 (0.56%) 
General physical health deterioration  1  2/176 (1.14%)  1/180 (0.56%) 
Localised oedema  1  0/176 (0.00%)  1/180 (0.56%) 
Oedema peripheral  1  1/176 (0.57%)  1/180 (0.56%) 
Pyrexia  1  3/176 (1.70%)  0/180 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/176 (0.57%)  0/180 (0.00%) 
Cholelithiasis  1  0/176 (0.00%)  1/180 (0.56%) 
Immune system disorders     
Anaphylactic shock  1  1/176 (0.57%)  0/180 (0.00%) 
Infections and infestations     
Appendicitis  1  1/176 (0.57%)  1/180 (0.56%) 
Cellulitis  1  1/176 (0.57%)  0/180 (0.00%) 
Diverticulitis  1  1/176 (0.57%)  0/180 (0.00%) 
Gastroenteritis  1  1/176 (0.57%)  0/180 (0.00%) 
Herpes zoster  1  0/176 (0.00%)  1/180 (0.56%) 
Lung infection  1  1/176 (0.57%)  1/180 (0.56%) 
Neurosyphilis  1  1/176 (0.57%)  0/180 (0.00%) 
Pneumonia  1  5/176 (2.84%)  5/180 (2.78%) 
Pneumonia influenzal  1  1/176 (0.57%)  0/180 (0.00%) 
Pyelonephritis  1  1/176 (0.57%)  0/180 (0.00%) 
Pyelonephritis acute  1  1/176 (0.57%)  0/180 (0.00%) 
Respiratory tract infection  1  1/176 (0.57%)  0/180 (0.00%) 
Sepsis  1  3/176 (1.70%)  2/180 (1.11%) 
Septic shock  1  0/176 (0.00%)  1/180 (0.56%) 
Sialoadenitis  1  1/176 (0.57%)  0/180 (0.00%) 
Upper respiratory tract infection  1  0/176 (0.00%)  2/180 (1.11%) 
Urinary tract infection  1  1/176 (0.57%)  1/180 (0.56%) 
Injury, poisoning and procedural complications     
Fall  1  1/176 (0.57%)  0/180 (0.00%) 
Femur fracture  1  1/176 (0.57%)  0/180 (0.00%) 
Infusion related reaction  1  2/176 (1.14%)  0/180 (0.00%) 
Lower limb fracture  1  1/176 (0.57%)  0/180 (0.00%) 
Rib fracture  1  1/176 (0.57%)  0/180 (0.00%) 
Spinal compression fracture  1  1/176 (0.57%)  0/180 (0.00%) 
Traumatic fracture  1  0/176 (0.00%)  1/180 (0.56%) 
Metabolism and nutrition disorders     
Dehydration  1  0/176 (0.00%)  1/180 (0.56%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  1/176 (0.57%)  0/180 (0.00%) 
Seronegative arthritis  1  1/176 (0.57%)  0/180 (0.00%) 
Spinal pain  1  1/176 (0.57%)  0/180 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  0/176 (0.00%)  1/180 (0.56%) 
Invasive ductal breast carcinoma  1  0/176 (0.00%)  1/180 (0.56%) 
Malignant melanoma  1  0/176 (0.00%)  1/180 (0.56%) 
Squamous cell carcinoma of skin  1  2/176 (1.14%)  0/180 (0.00%) 
Transitional cell cancer of the renal pelvis and ureter localised  1  0/176 (0.00%)  1/180 (0.56%) 
Tumour flare  1  1/176 (0.57%)  0/180 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  1  1/176 (0.57%)  1/180 (0.56%) 
Syncope  1  0/176 (0.00%)  2/180 (1.11%) 
Transient ischaemic attack  1  0/176 (0.00%)  2/180 (1.11%) 
Renal and urinary disorders     
Acute kidney injury  1  2/176 (1.14%)  0/180 (0.00%) 
Haematuria  1  0/176 (0.00%)  1/180 (0.56%) 
Renal colic  1  0/176 (0.00%)  1/180 (0.56%) 
Reproductive system and breast disorders     
Adnexal torsion  1  0/176 (0.00%)  1/180 (0.56%) 
Respiratory, thoracic and mediastinal disorders     
Acute lung injury  1  1/176 (0.57%)  0/180 (0.00%) 
Asthmatic crisis  1  1/176 (0.57%)  0/180 (0.00%) 
Chronic obstructive pulmonary disease  1  1/176 (0.57%)  0/180 (0.00%) 
Dyspnoea  1  1/176 (0.57%)  1/180 (0.56%) 
Pleural effusion  1  1/176 (0.57%)  3/180 (1.67%) 
Pulmonary embolism  1  4/176 (2.27%)  1/180 (0.56%) 
Respiratory failure  1  2/176 (1.14%)  0/180 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus generalised  1  1/176 (0.57%)  0/180 (0.00%) 
Rash maculo-papular  1  1/176 (0.57%)  0/180 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  1/176 (0.57%)  0/180 (0.00%) 
Lymphoedema  1  1/176 (0.57%)  0/180 (0.00%) 
Peripheral arterial occlusive disease  1  0/176 (0.00%)  1/180 (0.56%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rituximab and Lenalidomide Rituximab and Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   170/176 (96.59%)   160/180 (88.89%) 
Blood and lymphatic system disorders     
Anaemia  1  28/176 (15.91%)  8/180 (4.44%) 
Leukopenia  1  36/176 (20.45%)  17/180 (9.44%) 
Lymphopenia  1  8/176 (4.55%)  14/180 (7.78%) 
Neutropenia  1  102/176 (57.95%)  40/180 (22.22%) 
Thrombocytopenia  1  26/176 (14.77%)  8/180 (4.44%) 
Gastrointestinal disorders     
Abdominal pain  1  22/176 (12.50%)  16/180 (8.89%) 
Abdominal pain upper  1  12/176 (6.82%)  7/180 (3.89%) 
Constipation  1  46/176 (26.14%)  25/180 (13.89%) 
Diarrhoea  1  55/176 (31.25%)  41/180 (22.78%) 
Dyspepsia  1  16/176 (9.09%)  5/180 (2.78%) 
Nausea  1  20/176 (11.36%)  23/180 (12.78%) 
Stomatitis  1  9/176 (5.11%)  7/180 (3.89%) 
Vomiting  1  17/176 (9.66%)  13/180 (7.22%) 
General disorders     
Asthenia  1  24/176 (13.64%)  18/180 (10.00%) 
Chills  1  14/176 (7.95%)  8/180 (4.44%) 
Fatigue  1  38/176 (21.59%)  33/180 (18.33%) 
Influenza like illness  1  9/176 (5.11%)  7/180 (3.89%) 
Malaise  1  13/176 (7.39%)  10/180 (5.56%) 
Oedema peripheral  1  23/176 (13.07%)  15/180 (8.33%) 
Pyrexia  1  36/176 (20.45%)  27/180 (15.00%) 
Infections and infestations     
Influenza  1  17/176 (9.66%)  8/180 (4.44%) 
Nasopharyngitis  1  13/176 (7.39%)  18/180 (10.00%) 
Pneumonia  1  11/176 (6.25%)  1/180 (0.56%) 
Sinusitis  1  13/176 (7.39%)  5/180 (2.78%) 
Upper respiratory tract infection  1  32/176 (18.18%)  22/180 (12.22%) 
Urinary tract infection  1  12/176 (6.82%)  7/180 (3.89%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  25/176 (14.20%)  24/180 (13.33%) 
Investigations     
Alanine aminotransferase increased  1  18/176 (10.23%)  15/180 (8.33%) 
Aspartate aminotransferase increased  1  9/176 (5.11%)  9/180 (5.00%) 
Blood bilirubin increased  1  10/176 (5.68%)  0/180 (0.00%) 
Lymphocyte count decreased  1  12/176 (6.82%)  12/180 (6.67%) 
Weight decreased  1  12/176 (6.82%)  2/180 (1.11%) 
White blood cell count decreased  1  16/176 (9.09%)  13/180 (7.22%) 
Metabolism and nutrition disorders     
Decreased appetite  1  23/176 (13.07%)  11/180 (6.11%) 
Hyperglycaemia  1  11/176 (6.25%)  11/180 (6.11%) 
Hyperuricaemia  1  10/176 (5.68%)  8/180 (4.44%) 
Hypokalaemia  1  14/176 (7.95%)  5/180 (2.78%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  15/176 (8.52%)  14/180 (7.78%) 
Back pain  1  14/176 (7.95%)  18/180 (10.00%) 
Muscle spasms  1  23/176 (13.07%)  9/180 (5.00%) 
Myalgia  1  10/176 (5.68%)  12/180 (6.67%) 
Pain in extremity  1  8/176 (4.55%)  9/180 (5.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour flare  1  18/176 (10.23%)  1/180 (0.56%) 
Nervous system disorders     
Dizziness  1  15/176 (8.52%)  9/180 (5.00%) 
Headache  1  26/176 (14.77%)  17/180 (9.44%) 
Psychiatric disorders     
Insomnia  1  14/176 (7.95%)  11/180 (6.11%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  40/176 (22.73%)  31/180 (17.22%) 
Dyspnoea  1  18/176 (10.23%)  7/180 (3.89%) 
Oropharyngeal pain  1  10/176 (5.68%)  8/180 (4.44%) 
Productive cough  1  12/176 (6.82%)  8/180 (4.44%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  9/176 (5.11%)  6/180 (3.33%) 
Pruritus  1  21/176 (11.93%)  7/180 (3.89%) 
Pruritus generalised  1  14/176 (7.95%)  3/180 (1.67%) 
Rash  1  19/176 (10.80%)  7/180 (3.89%) 
Rash maculo-papular  1  14/176 (7.95%)  4/180 (2.22%) 
Vascular disorders     
Hypertension  1  6/176 (3.41%)  11/180 (6.11%) 
Hypotension  1  9/176 (5.11%)  1/180 (0.56%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
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.
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is > 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
Organization: Celgene Corporationi
Phone: 888-260-1599
EMail: ClinicalTrialDisclosure@Celgene.com
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01938001     History of Changes
Other Study ID Numbers: CC-5013-NHL-007
First Submitted: September 5, 2013
First Posted: September 10, 2013
Results First Submitted: June 21, 2019
Results First Posted: August 13, 2019
Last Update Posted: August 13, 2019