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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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00722137
First received: July 23, 2008
Last updated: November 8, 2014
Last verified: November 2014
Results First Received: November 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 487 participants were randomized from 128 centers in 28 countries from 22 May 2008 to 05 December 2011; 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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
VcR-CAP

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

R-CHOP

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


Participant Flow:   Overall Study
    VcR-CAP     R-CHOP  
STARTED     243     244  
COMPLETED     195     199  
NOT COMPLETED     48     45  
Overt Disease Progression                 4                 5  
Adverse Event                 21                 17  
Death                 7                 12  
Withdrawal by Subject                 9                 6  
Other Reason Uknown                 4                 3  
Randomized But Not Treated                 3                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The population consisted of all randomized participants.

Reporting Groups
  Description
R-CHOP

Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone

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 1of 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 1of a 21 day (3 week) cycle for 6 cycles

VcR-CAP

Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone

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 1of a 21 day (3 week) cycle for 6 cycles

VELCADE: VELCADE intravenous on Days 1,4,8, and 11of 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 Total of all reporting groups

Baseline Measures
    R-CHOP     VcR-CAP     Total  
Number of Participants  
[units: participants]
  244     243     487  
Age  
[units: Years]
Mean ± Standard Deviation
  64.4  ± 8.78     64.2  ± 9.68     64.3  ± 9.23  
Gender  
[units: Participants]
     
Female     62     65     127  
Male     182     178     360  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     68     88     156  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     3     3  
White     172     151     323  
More than one race     4     1     5  
Unknown or Not Reported     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: Median duration of follow-up of 40 months ]

2.  Secondary:   Time to Progression (TTP)   [ Time Frame: Median duration of follow-up of 40 months ]

3.  Secondary:   Duration of Response   [ Time Frame: Median duration of follow-up of 40 months ]

4.  Secondary:   Time to Next Anti-lymphoma Treatment (TTNT)   [ Time Frame: : Median duration of follow-up of 40 months ]

5.  Secondary:   Treatment-free Interval (TFI)   [ Time Frame: Median duration of follow-up of 40 months ]

6.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: Median duration of follow-up of 40 months ]

7.  Secondary:   Overall Complete Response (CR + CRu)   [ Time Frame: Median duration of follow-up of 40 months ]

8.  Secondary:   Overall Survival (OS)   [ Time Frame: Median duration of follow-up of 40 months ]

9.  Secondary:   18-Month Survival   [ Time Frame: Up to month 18 from the time of randomization ]

10.  Secondary:   Number of Participants Experiencing an Adverse Event (AE)   [ Time Frame: Up to Week 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Helgi van de Velde
Organization: Johnson & Johnson Pharmaceutical Research & Development
e-mail: clinicaltrialregistry@takeda.com


No publications provided


Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00722137     History of Changes
Other Study ID Numbers: 26866138-LYM-3002, 26866138-LYM-3002CTIL, U1111-1150-2776, 2007-005669-37
Study First Received: July 23, 2008
Results First Received: November 8, 2014
Last Updated: November 8, 2014
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Japan: Ministry of Health, Labor and Welfare
Korea: Food and Drug Administration