Velcade (Bortezomib, PS-341) and Rituximab in Relapsed/Refractory Mantle Cell and Follicular Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kristie Blum, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201877
First received: September 12, 2005
Last updated: April 17, 2014
Last verified: April 2014
Results First Received: November 12, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma
Interventions: Drug: Velcade
Drug: Rituximab

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From December 2005 until June 2009, 25 patients aged ≥ 18 years with historically confirmed, grade 1 or 2 mantel cell or follicular NHL according to the World Health Organization classification who relapsed or were refractory after at least 1 previous therapy.

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
Velcade and Rituximab

Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.

Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14


Participant Flow:   Overall Study
    Velcade and Rituximab  
STARTED     25  
COMPLETED     25  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Velcade and Rituximab

Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.

Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14


Baseline Measures
    Velcade and Rituximab  
Number of Participants  
[units: participants]
  25  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     9  
>=65 years     16  
Gender  
[units: participants]
 
Female     7  
Male     18  
Region of Enrollment  
[units: participants]
 
United States     25  
Lymphoma Disease Stages [1]
[units: participants]
 
I(lymph node area or 1 organ outside lymph system     2  
II(2 or more groups of lymph nodes)     1  
Stage III(lymph node areas on both sides)     9  
IV(outside lymph system into organ)     13  
B-symptoms  
[units: participants]
 
Yes     6  
No     19  
Disease Type  
[units: participants]
 
Mantle cell lymphoma     14  
Follicular lymphoma     11  
[1] Ann Arbor staging system



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Response Rate   [ Time Frame: Every 3 months ]

2.  Primary:   Assess the Toxicity of Combination Rituximab and Velcade™ in Patients With Previously Treated Mantle Cell and Follicular Lymphoma.   [ Time Frame: Day 1 of each cycle ]

3.  Secondary:   Progression-free Survival(PFS)   [ Time Frame: 2 years ]

4.  Secondary:   Correlative Studies   [ Time Frame: During induction (weeks 1-15); PK every 2 months during maintenance. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


Results Point of Contact:  
Name/Title: Kristie Blum, MD
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-4519
e-mail: Kristie.Blum@osumc.edu


No publications provided


Responsible Party: Kristie Blum, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201877     History of Changes
Other Study ID Numbers: OSU-0430, NCI-2011-03233
Study First Received: September 12, 2005
Results First Received: November 12, 2013
Last Updated: April 17, 2014
Health Authority: United States: Institutional Review Board