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Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00722137
Recruitment Status : Completed
First Posted : July 25, 2008
Results First Posted : November 17, 2014
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mantle Cell Lymphoma
Interventions Drug: Rituximab 375 mg/m^2
Drug: Cyclophosphamide 750 mg/m^2
Drug: Doxorubicin 50 mg/m^2
Drug: VELCADE 1.3 mg/m^2
Drug: Prednisone 100 mg/m^2
Drug: Vincristine 1.4 mg/m^2
Enrollment 487
Recruitment Details A total of 487 participants were randomized from 128 centers in 28 countries from 22 May 2008 to 17 June 2017; 244 to the R-CHOP treatment group and 243 to the VcR-CAP treatment group. Of the 487 randomized participants, 242 in the R-CHOP group and 240 in the VcR-CAP group received at least 1 dose of study drug.
Pre-assignment Details  
Arm/Group Title R-CHOP VcR-CAP
Hide Arm/Group Description Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
Period Title: Overall Study
Started 244 243
Completed [1] 199 195
Not Completed 45 48
Reason Not Completed
Overt Disease Progression             5             4
Adverse Event             17             21
Death             12             7
Withdrawal by Subject             6             9
Other Reason Unknown             3             4
Randomized But Not Treated             2             3
[1]
Completed participants are the participants who completed the treatment.
Arm/Group Title R-CHOP VcR-CAP Total
Hide Arm/Group Description Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles. Total of all reporting groups
Overall Number of Baseline Participants 244 243 487
Hide Baseline Analysis Population Description
The population consisted of all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 244 participants 243 participants 487 participants
64.4  (8.78) 64.2  (9.68) 64.3  (9.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 243 participants 487 participants
Female
62
  25.4%
65
  26.7%
127
  26.1%
Male
182
  74.6%
178
  73.3%
360
  73.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 243 participants 487 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
68
  27.9%
88
  36.2%
156
  32.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
3
   1.2%
3
   0.6%
White
172
  70.5%
151
  62.1%
323
  66.3%
More than one race
4
   1.6%
1
   0.4%
5
   1.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 243 participants 487 participants
Belgium
10
   4.1%
16
   6.6%
26
   5.3%
Poland
9
   3.7%
10
   4.1%
19
   3.9%
Czech Republic
5
   2.0%
9
   3.7%
14
   2.9%
Spain
8
   3.3%
6
   2.5%
14
   2.9%
Hungary
5
   2.0%
8
   3.3%
13
   2.7%
Romania
9
   3.7%
4
   1.6%
13
   2.7%
Austria
6
   2.5%
4
   1.6%
10
   2.1%
Italy
6
   2.5%
3
   1.2%
9
   1.8%
Germany
7
   2.9%
1
   0.4%
8
   1.6%
Portugal
3
   1.2%
4
   1.6%
7
   1.4%
France
1
   0.4%
2
   0.8%
3
   0.6%
Canada
6
   2.5%
1
   0.4%
7
   1.4%
United States
2
   0.8%
5
   2.1%
7
   1.4%
Russia
57
  23.4%
42
  17.3%
99
  20.3%
China
34
  13.9%
61
  25.1%
95
  19.5%
Ukraine
18
   7.4%
16
   6.6%
34
   7.0%
Brazil
9
   3.7%
13
   5.3%
22
   4.5%
Thailand
9
   3.7%
10
   4.1%
19
   3.9%
Japan
11
   4.5%
7
   2.9%
18
   3.7%
India
9
   3.7%
3
   1.2%
12
   2.5%
Israel
5
   2.0%
2
   0.8%
7
   1.4%
Tunisia
3
   1.2%
3
   1.2%
6
   1.2%
Turkey
5
   2.0%
1
   0.4%
6
   1.2%
Colombia
2
   0.8%
3
   1.2%
5
   1.0%
Korea, Republic Of
2
   0.8%
3
   1.2%
5
   1.0%
Chile
1
   0.4%
2
   0.8%
3
   0.6%
Singapore
1
   0.4%
2
   0.8%
3
   0.6%
Taiwan, Province Of China
1
   0.4%
2
   0.8%
3
   0.6%
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was defined as the interval between the date of randomization and the date of progressive disease (PD) or death, whichever occurred first. PD was based on the assessment of an Independent Review Committee.
Time Frame Median duration of follow-up of 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all randomized participants.
Arm/Group Title R-CHOP VcR-CAP
Hide Arm/Group Description:
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
Overall Number of Participants Analyzed 244 243
Median (95% Confidence Interval)
Unit of Measure: Days
437.0
(365.0 to 513.0)
751.0
(604.0 to 969.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection R-CHOP, VcR-CAP
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 Log Rank
Comments Based on Log rank test stratified with International Prognostic Index (IPI) risk and stage of disease.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.63
Confidence Interval (2-Sided) 95%
0.50 to 0.79
Estimation Comments Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio < 1 indicates an advantage for VcR-CAP.
2.Secondary Outcome
Title Time to Progression (TTP)
Hide Description Time to progression was defined as the duration from the date of randomization until the date of first documented evidence of progressive disease (PD) or date of relapse for subjects who experienced complete response (CR) or complete response, unconfirmed (CRu). PD and response were based on the assessment of an Independent Review Committee.
Time Frame Median duration of follow-up of 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all randomized participants.
Arm/Group Title R-CHOP VcR-CAP
Hide Arm/Group Description:
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
Overall Number of Participants Analyzed 244 243
Median (95% Confidence Interval)
Unit of Measure: Days
490.0
(417.0 to 550.0)
929.0
(696.0 to 1245.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection R-CHOP, VcR-CAP
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 Log Rank
Comments Based on Log rank test stratified with IPI risk and stage of disease.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.45 to 0.74
Estimation Comments Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio < 1 indicates an advantage for VcR-CAP.
3.Secondary Outcome
Title Duration of Response
Hide Description The duration of treatment response was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR, CRu, or PR as determined by the Independent Review Committee. The duration of response for complete responders was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR or CRu verified by bone marrow and lactate dehydrogenase (LDH).
Time Frame Median duration of follow-up of 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
The response-evaluable population was defined as all participants who received at least 1 dose of study drug, had >= 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.
Arm/Group Title R-CHOP VcR-CAP
Hide Arm/Group Description:
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
Overall Number of Participants Analyzed 228 229
Median (95% Confidence Interval)
Unit of Measure: Days
Duration of response Number Analyzed 204 participants 211 participants
459.0
(379.0 to 518.0)
1110.0
(813.0 to 1320.0)
Duration for Complete responders Number Analyzed 95 participants 122 participants
563.0
(486.0 to 738.0)
1282.0
(933.0 to 1602.0)
4.Secondary Outcome
Title Time to Next Anti-lymphoma Treatment (TTNT)
Hide Description The time to next anti-lymphomatreatment was measured from the date of initiation of study treatment as per protocol to the start date of new anti-lymphoma treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti lymphoma treatment was censored at the date of death or the last date known to be alive.
Time Frame : Median duration of follow-up of 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all randomized participants.
Arm/Group Title R-CHOP VcR-CAP
Hide Arm/Group Description:
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
Overall Number of Participants Analyzed 244 243
Median (95% Confidence Interval)
Unit of Measure: Days
756.0
(674.0 to 837.0)
1353.0 [1] 
(1180.0 to NA)
[1]
The upper limit of the confidence interval was not able to be estimated.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection R-CHOP, VcR-CAP
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 Log Rank
Comments Based on Log rank test stratified with IPI risk and stage of disease.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.38 to 0.65
Estimation Comments Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio < 1 indicates an advantage for VcR-CAP.
5.Secondary Outcome
Title Treatment-free Interval (TFI)
Hide Description The TFI was defined as the duration from the date of last dose plus 1 day to the start date of the new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, treatment-free interval was censored at the date of death or the last date known to be alive.
Time Frame Median duration of follow-up of 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title R-CHOP VcR-CAP
Hide Arm/Group Description:
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
Overall Number of Participants Analyzed 242 240
Median (95% Confidence Interval)
Unit of Measure: Days
624.0
(542.0 to 693.0)
1236.0 [1] 
(1023.0 to NA)
[1]
The upper limit of the confidence interval was not able to be estimated.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection R-CHOP, VcR-CAP
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 Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.38 to 0.65
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR was defined as complete response (CR) + complete response, unconfirmed (CRu) + partial response (PR) as determined by the Independent Review Committee. Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.
Time Frame Median duration of follow-up of 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
The response-evaluable population was defined as all participants who received >= 1 dose of study drug, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.
Arm/Group Title R-CHOP VcR-CAP
Hide Arm/Group Description:
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
Overall Number of Participants Analyzed 228 229
Measure Type: Number
Unit of Measure: Participants
204 211
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection R-CHOP, VcR-CAP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.275
Comments [Not Specified]
Method Cochran-Mantel-Haenszel Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.428
Confidence Interval (2-Sided) 95%
0.749 to 2.722
Estimation Comments Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and Stage of Disease as stratification factors. An odds ratio (OR) > 1 indicates an advantage for VcR-CAP.
7.Secondary Outcome
Title Overall Complete Response (CR + CRu)
Hide Description Overall complete response was defined as the number of participants with complete response (CR) and those with unconfirmed complete response (CRu). Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.
Time Frame Median duration of follow-up of 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
The response-evaluable population was defined as all participants who received >= 1 dose of study drug, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.
Arm/Group Title R-CHOP VcR-CAP
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Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
Overall Number of Participants Analyzed 228 229
Measure Type: Number
Unit of Measure: Participants
Overall complete response 95 122
CR 79 106
CRu 16 16
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection R-CHOP, VcR-CAP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.007
Comments [Not Specified]
Method Cochran-Mantel-Haenszel Chi-Square
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.688
Confidence Interval (2-Sided) 95%
1.148 to 2.481
Estimation Comments Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and Stage of Disease as stratification factors. An odds ratio (OR) > 1 indicates an advantage for VcR-CAP.
8.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive.
Time Frame Median duration of follow-up of 40 months
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Hide Analysis Population Description
The population consisted of all randomized participants.
Arm/Group Title R-CHOP VcR-CAP
Hide Arm/Group Description:
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
Overall Number of Participants Analyzed 244 243
Median (95% Confidence Interval)
Unit of Measure: Days
1714.0 [1] 
(1436.0 to NA)
NA [2] 
(1704.0 to NA)
[1]
The upper limit of the confidence interval was not able to be estimated.
[2]
The median was not reached and the upper limit of the confidence interval was not able to be estimated.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection R-CHOP, VcR-CAP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.173
Comments [Not Specified]
Method Log Rank
Comments Based on Log rank test stratified with IPI risk and stage of disease.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.59 to 1.10
Estimation Comments Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio < 1 indicates an advantage for VcR-CAP.
9.Secondary Outcome
Title 18-Month Survival
Hide Description 18-month survival was defined as the estimated probability of survival at 18 months (Kaplan-Meier estimate).
Time Frame Up to month 18 from the time of randomization
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Hide Analysis Population Description
The population consisted of all randomized participants.
Arm/Group Title R-CHOP VcR-CAP
Hide Arm/Group Description:
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
Overall Number of Participants Analyzed 244 243
Mean (95% Confidence Interval)
Unit of Measure: Percentage of Participants
83.8
(78.4 to 87.9)
84.9
(79.6 to 88.9)
10.Secondary Outcome
Title Overall Survival (OS) in Long Term Follow-up Period
Hide Description OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive.
Time Frame Up to 107.4 months
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Hide Analysis Population Description
The population consisted of all randomized participants.
Arm/Group Title R-CHOP VcR-CAP
Hide Arm/Group Description:
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
Overall Number of Participants Analyzed 244 243
Median (95% Confidence Interval)
Unit of Measure: Days
1695.0
(1436.0 to 2098.0)
2760.0 [1] 
(2172.0 to NA)
[1]
Upper limit of overall survival after long term follow-up was not estimable due low number of participants with the event.
11.Secondary Outcome
Title Number of Participants Experiencing an Adverse Event (AE)
Hide Description An AE was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. AEs were collected from the first dose of study drug through 30 days after the last dose of study drug. Treatment was administered for up to 8 cycles (24 weeks) and AEs were collected for up to 30 days following the last dose of study drug.
Time Frame Up to 107.4 months
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Hide Analysis Population Description
The safety population was defined as all randomized participants who received at least 1 dose of study medication.
Arm/Group Title R-CHOP VcR-CAP
Hide Arm/Group Description:
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
Overall Number of Participants Analyzed 242 240
Measure Type: Number
Unit of Measure: Participants
239 240
Time Frame Up to 107.4 months
Adverse Event Reporting Description The safety population was defined as all randomized participants who received at least 1 dose of study medication.
 
Arm/Group Title R-CHOP VcR-CAP
Hide Arm/Group Description Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
All-Cause Mortality
R-CHOP VcR-CAP
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
R-CHOP VcR-CAP
Affected / at Risk (%) Affected / at Risk (%)
Total   72/242 (29.75%)   91/240 (37.92%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  20/242 (8.26%)  26/240 (10.83%) 
Neutropenia  1  13/242 (5.37%)  12/240 (5.00%) 
Thrombocytopenia  1  1/242 (0.41%)  8/240 (3.33%) 
Leukopenia  1  3/242 (1.24%)  6/240 (2.50%) 
Anaemia  1  5/242 (2.07%)  4/240 (1.67%) 
Lymphopenia  1  0/242 (0.00%)  1/240 (0.42%) 
Bone marrow failure  1  0/242 (0.00%)  1/240 (0.42%) 
Cardiac disorders     
Left ventricular dysfunction  1  0/242 (0.00%)  3/240 (1.25%) 
Cardiac failure  1  0/242 (0.00%)  2/240 (0.83%) 
Atrial fibrillation  1  2/242 (0.83%)  1/240 (0.42%) 
Cardiac failure congestive  1  0/242 (0.00%)  1/240 (0.42%) 
Cardiogenic shock  1  0/242 (0.00%)  1/240 (0.42%) 
Myocardial ischaemia  1  1/242 (0.41%)  1/240 (0.42%) 
Sinus tachycardia  1  0/242 (0.00%)  1/240 (0.42%) 
Supraventricular extrasystoles  1  0/242 (0.00%)  1/240 (0.42%) 
Acute left ventricular failure  1  1/242 (0.41%)  0/240 (0.00%) 
Acute myocardial infarction  1  1/242 (0.41%)  0/240 (0.00%) 
Cardiac arrest  1  1/242 (0.41%)  0/240 (0.00%) 
Cardiac failure acute  1  1/242 (0.41%)  0/240 (0.00%) 
Cardio-respiratory arrest  1  2/242 (0.83%)  0/240 (0.00%) 
Cardiomyopathy  1  1/242 (0.41%)  0/240 (0.00%) 
Cardiopulmonary failure  1  1/242 (0.41%)  0/240 (0.00%) 
Left ventricular failure  1  1/242 (0.41%)  0/240 (0.00%) 
Myocardial infarction  1  2/242 (0.83%)  0/240 (0.00%) 
Tachycardia  1  2/242 (0.83%)  0/240 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  3/242 (1.24%)  4/240 (1.67%) 
Vomiting  1  1/242 (0.41%)  2/240 (0.83%) 
Abdominal adhesions  1  0/242 (0.00%)  1/240 (0.42%) 
Colitis  1  1/242 (0.41%)  1/240 (0.42%) 
Gastritis  1  0/242 (0.00%)  1/240 (0.42%) 
Gastrointestinal haemorrhage  1  0/242 (0.00%)  1/240 (0.42%) 
Ileus paralytic  1  0/242 (0.00%)  1/240 (0.42%) 
Melaena  1  1/242 (0.41%)  1/240 (0.42%) 
Mouth ulceration  1  0/242 (0.00%)  1/240 (0.42%) 
Oesophagitis  1  0/242 (0.00%)  1/240 (0.42%) 
Stomatitis  1  2/242 (0.83%)  1/240 (0.42%) 
Anal fissure  1  1/242 (0.41%)  0/240 (0.00%) 
Constipation  1  1/242 (0.41%)  0/240 (0.00%) 
Haematemesis  1  1/242 (0.41%)  0/240 (0.00%) 
Pancreatitis  1  1/242 (0.41%)  0/240 (0.00%) 
Periproctitis  1  1/242 (0.41%)  0/240 (0.00%) 
Small intestinal obstruction  1  1/242 (0.41%)  0/240 (0.00%) 
General disorders     
Pyrexia  1  4/242 (1.65%)  10/240 (4.17%) 
Acute phase reaction  1  0/242 (0.00%)  1/240 (0.42%) 
Asthenia  1  0/242 (0.00%)  1/240 (0.42%) 
Chills  1  1/242 (0.41%)  1/240 (0.42%) 
Death  1  0/242 (0.00%)  1/240 (0.42%) 
Cardiac death  1  1/242 (0.41%)  0/240 (0.00%) 
Chest pain  1  1/242 (0.41%)  0/240 (0.00%) 
Fatigue  1  3/242 (1.24%)  0/240 (0.00%) 
Oedema peripheral  1  1/242 (0.41%)  0/240 (0.00%) 
Hepatobiliary disorders     
Hepatic failure  1  0/242 (0.00%)  1/240 (0.42%) 
Bile duct stone  1  1/242 (0.41%)  0/240 (0.00%) 
Hepatic function abnormal  1  1/242 (0.41%)  0/240 (0.00%) 
Infections and infestations     
Pneumonia  1  7/242 (2.89%)  19/240 (7.92%) 
Sepsis  1  1/242 (0.41%)  4/240 (1.67%) 
Bronchitis  1  2/242 (0.83%)  2/240 (0.83%) 
Lobar pneumonia  1  1/242 (0.41%)  2/240 (0.83%) 
Lung infection  1  1/242 (0.41%)  2/240 (0.83%) 
Pneumonia streptococcal  1  0/242 (0.00%)  2/240 (0.83%) 
Septic shock  1  1/242 (0.41%)  2/240 (0.83%) 
Abscess neck  1  0/242 (0.00%)  1/240 (0.42%) 
Bronchopneumonia  1  1/242 (0.41%)  1/240 (0.42%) 
Candidiasis  1  0/242 (0.00%)  1/240 (0.42%) 
Cellulitis  1  0/242 (0.00%)  1/240 (0.42%) 
Erysipelas  1  0/242 (0.00%)  1/240 (0.42%) 
Hepatitis B  1  2/242 (0.83%)  1/240 (0.42%) 
Herpes zoster  1  1/242 (0.41%)  1/240 (0.42%) 
Klebsiella sepsis  1  0/242 (0.00%)  1/240 (0.42%) 
Nosocomial infection  1  0/242 (0.00%)  1/240 (0.42%) 
Parotitis  1  0/242 (0.00%)  1/240 (0.42%) 
Pneumonia bacterial  1  0/242 (0.00%)  1/240 (0.42%) 
Pneumonia cytomegaloviral  1  0/242 (0.00%)  1/240 (0.42%) 
Postoperative abscess  1  0/242 (0.00%)  1/240 (0.42%) 
Pulmonary mycosis  1  0/242 (0.00%)  1/240 (0.42%) 
Respiratory tract infection  1  1/242 (0.41%)  1/240 (0.42%) 
Salmonellosis  1  0/242 (0.00%)  1/240 (0.42%) 
Upper respiratory tract infection  1  1/242 (0.41%)  1/240 (0.42%) 
Urinary tract infection  1  0/242 (0.00%)  1/240 (0.42%) 
Anal abscess  1  1/242 (0.41%)  0/240 (0.00%) 
Bacterial sepsis  1  1/242 (0.41%)  0/240 (0.00%) 
Clostridium difficile infection  1  1/242 (0.41%)  0/240 (0.00%) 
Endocarditis bacterial  1  1/242 (0.41%)  0/240 (0.00%) 
Escherichia urinary tract infection  1  1/242 (0.41%)  0/240 (0.00%) 
Gastroenteritis  1  2/242 (0.83%)  0/240 (0.00%) 
Oral fungal infection  1  1/242 (0.41%)  0/240 (0.00%) 
Oral herpes  1  1/242 (0.41%)  0/240 (0.00%) 
Oropharyngeal candidiasis  1  1/242 (0.41%)  0/240 (0.00%) 
Paronychia  1  1/242 (0.41%)  0/240 (0.00%) 
Peritonsillar abscess  1  1/242 (0.41%)  0/240 (0.00%) 
Pulmonary tuberculosis  1  1/242 (0.41%)  0/240 (0.00%) 
Rectal abscess  1  1/242 (0.41%)  0/240 (0.00%) 
Tracheobronchitis  1  1/242 (0.41%)  0/240 (0.00%) 
Injury, poisoning and procedural complications     
Femur fracture  1  1/242 (0.41%)  1/240 (0.42%) 
Compression fracture  1  1/242 (0.41%)  0/240 (0.00%) 
Traumatic lung injury  1  1/242 (0.41%)  0/240 (0.00%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  0/242 (0.00%)  2/240 (0.83%) 
Decreased appetite  1  0/242 (0.00%)  1/240 (0.42%) 
Fluid retention  1  0/242 (0.00%)  1/240 (0.42%) 
Hyponatraemia  1  0/242 (0.00%)  1/240 (0.42%) 
Tumour lysis syndrome  1  2/242 (0.83%)  1/240 (0.42%) 
Dehydration  1  1/242 (0.41%)  0/240 (0.00%) 
Diabetes mellitus  1  1/242 (0.41%)  0/240 (0.00%) 
Musculoskeletal and connective tissue disorders     
Soft tissue necrosis  1  1/242 (0.41%)  0/240 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant melanoma  1  1/242 (0.41%)  0/240 (0.00%) 
Gastric cancer  1 [1]  0/242 (0.00%)  1/240 (0.42%) 
Nervous system disorders     
Neuralgia  1  0/242 (0.00%)  2/240 (0.83%) 
Autonomic neuropathy  1  0/242 (0.00%)  1/240 (0.42%) 
Cerebral ischaemia  1  0/242 (0.00%)  1/240 (0.42%) 
Depressed level of consciousness  1  0/242 (0.00%)  1/240 (0.42%) 
Encephalitis  1  0/242 (0.00%)  1/240 (0.42%) 
Peripheral sensorimotor neuropathy  1  0/242 (0.00%)  1/240 (0.42%) 
Peripheral sensory neuropathy  1  0/242 (0.00%)  1/240 (0.42%) 
Syncope  1  0/242 (0.00%)  1/240 (0.42%) 
Cerebrovascular accident  1  1/242 (0.41%)  0/240 (0.00%) 
Convulsion  1  1/242 (0.41%)  0/240 (0.00%) 
Renal and urinary disorders     
Renal failure  1  1/242 (0.41%)  0/240 (0.00%) 
Renal impairment  1  1/242 (0.41%)  0/240 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  1/242 (0.41%)  4/240 (1.67%) 
Pleural effusion  1  1/242 (0.41%)  3/240 (1.25%) 
Dyspnoea  1  5/242 (2.07%)  2/240 (0.83%) 
Acute respiratory distress syndrome  1  0/242 (0.00%)  1/240 (0.42%) 
Aspiration  1  0/242 (0.00%)  1/240 (0.42%) 
Pneumonia aspiration  1  0/242 (0.00%)  1/240 (0.42%) 
Pulmonary hypertension  1  0/242 (0.00%)  1/240 (0.42%) 
Pulmonary oedema  1  0/242 (0.00%)  1/240 (0.42%) 
Respiratory failure  1  0/242 (0.00%)  1/240 (0.42%) 
Tonsillar haemorrhage  1  0/242 (0.00%)  1/240 (0.42%) 
Acute respiratory failure  1  1/242 (0.41%)  0/240 (0.00%) 
Epistaxis  1  1/242 (0.41%)  0/240 (0.00%) 
Lung infiltration  1  1/242 (0.41%)  0/240 (0.00%) 
Respiratory distress  1  2/242 (0.83%)  0/240 (0.00%) 
Vascular disorders     
Hypotension  1  1/242 (0.41%)  3/240 (1.25%) 
Orthostatic hypotension  1  0/242 (0.00%)  2/240 (0.83%) 
Poor venous access  1  0/242 (0.00%)  2/240 (0.83%) 
Deep vein thrombosis  1  3/242 (1.24%)  1/240 (0.42%) 
Hypertension  1  0/242 (0.00%)  1/240 (0.42%) 
Venous thrombosis  1  0/242 (0.00%)  1/240 (0.42%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
[1]
This serious adverse event occurred during long term follow-up period
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
R-CHOP VcR-CAP
Affected / at Risk (%) Affected / at Risk (%)
Total   187/242 (77.27%)   185/240 (77.08%) 
Gastrointestinal disorders     
Nausea  1  33/242 (13.64%)  59/240 (24.58%) 
Abdominal distension  1  5/242 (2.07%)  22/240 (9.17%) 
Abdominal pain  1  9/242 (3.72%)  18/240 (7.50%) 
Abdominal pain upper  1  11/242 (4.55%)  16/240 (6.67%) 
Dyspepsia  1  14/242 (5.79%)  13/240 (5.42%) 
Investigations     
Weight decreased  1  10/242 (4.13%)  14/240 (5.83%) 
Metabolism and nutrition disorders     
Hyperglycaemia  1  20/242 (8.26%)  18/240 (7.50%) 
Hypoalbuminaemia  1  11/242 (4.55%)  14/240 (5.83%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  5/242 (2.07%)  20/240 (8.33%) 
Back pain  1  15/242 (6.20%)  15/240 (6.25%) 
Nervous system disorders     
Neuropathy peripheral  1  19/242 (7.85%)  19/240 (7.92%) 
Paraesthesia  1  12/242 (4.96%)  16/240 (6.67%) 
Dizziness  1  9/242 (3.72%)  15/240 (6.25%) 
Hypoaesthesia  1  15/242 (6.20%)  15/240 (6.25%) 
Headache  1  11/242 (4.55%)  13/240 (5.42%) 
Psychiatric disorders     
Insomnia  1  18/242 (7.44%)  27/240 (11.25%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  20/242 (8.26%)  49/240 (20.42%) 
Oropharyngeal pain  1  10/242 (4.13%)  14/240 (5.83%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  33/242 (13.64%)  33/240 (13.75%) 
Rash  1  8/242 (3.31%)  13/240 (5.42%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT00722137    
Other Study ID Numbers: 26866138-LYM-3002
26866138-LYM-3002CTIL ( Other Identifier: Israel )
2007-005669-37 ( EudraCT Number )
0970313683 ( Registry Identifier: TCTIN )
U1111-1195-3827 ( Other Identifier: WHO )
First Submitted: July 23, 2008
First Posted: July 25, 2008
Results First Submitted: November 8, 2014
Results First Posted: November 17, 2014
Last Update Posted: July 12, 2018