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Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00151320
First Posted: September 8, 2005
Last Update Posted: April 7, 2017
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.
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Weill Medical College of Cornell University
Results First Submitted: February 23, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-Hodgkin's Lymphoma
Intervention: Drug: Bortezomib, CHOP, Rituximab

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm 1

Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles

Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)

VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by a dose escalation schedule.

Bortezomib, CHOP, Rituximab: Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)

VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:

Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4


Participant Flow:   Overall Study
    Arm 1
STARTED   76 
COMPLETED   76 
NOT COMPLETED   0 



  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.
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Reporting Groups
  Description
Untreated DLBCL with untreated Diffuse Large B-cell Lymphoma (n = 40)
Untreated MCL with untreated mantle cell Non-Hodgkin’s Lymphoma
Total Total of all reporting groups

Baseline Measures
   Untreated DLBCL   Untreated MCL   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   36   76 
Age 
[Units: Years]
Median (Full Range)
 56 
 (20 to 87) 
 66 
 (45 to 80) 
 63 
 (20 to 87) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      13  32.5%      6  16.7%      19  25.0% 
Male      27  67.5%      30  83.3%      57  75.0% 


  Outcome Measures

1.  Primary:   ORR   [ Time Frame: 6 cycles (18 weeks) ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: John Leonard, MD
Organization: Weill Cornell Medicine
phone: 646.962.2064
e-mail: amr2017@med.cornell.edu



Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00151320     History of Changes
Other Study ID Numbers: 0309006313
First Submitted: September 6, 2005
First Posted: September 8, 2005
Results First Submitted: February 23, 2017
Results First Posted: April 7, 2017
Last Update Posted: April 7, 2017