Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin 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: NCT00054639
Recruitment Status : Completed
First Posted : February 6, 2003
Results First Posted : February 21, 2011
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Intraocular Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Small Lymphocytic Lymphoma
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
Testicular Lymphoma
Waldenström Macroglobulinemia
Interventions Biological: oblimersen sodium
Biological: rituximab
Other: laboratory biomarker analysis
Enrollment 48
Recruitment Details Recruitment Period: January 07, 2003 to October 01, 2005. Recruitment was done at UT MD Anderson Cancer Center Clinics.
Pre-assignment Details Two participants enrolled but not assigned were not included in baseline measures. Of the total 48 participants enrolled, 42 were evaluable for response and 46 for toxicity.
Arm/Group Title Oblimersen + Rituximab
Hide Arm/Group Description Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
Period Title: Overall Study
Started 48
Completed 46
Not Completed 2
Reason Not Completed
Lack of Efficacy             1
Physician Decision             1
Arm/Group Title Oblimersen + Rituximab
Hide Arm/Group Description Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 46 participants
59
(35 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
33
  71.7%
Male
13
  28.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants
46
1.Primary Outcome
Title Number of Patients With Objective Response
Hide Description Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment
Time Frame 2 months following study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol. Of the 48 participants enrolled, only 42 were evaluable for response.
Arm/Group Title Oblimersen + Rituximab
Hide Arm/Group Description:
Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: participants
Complete Responses 10
Partial Responses 8
Time Frame 2 Years, 10 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oblimersen + Rituximab
Hide Arm/Group Description Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
All-Cause Mortality
Oblimersen + Rituximab
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Oblimersen + Rituximab
Affected / at Risk (%) # Events
Total   15/46 (32.61%)    
Blood and lymphatic system disorders   
Anaemia  1  1/46 (2.17%)  1
Thrombocytopenia  1  2/46 (4.35%)  2
Neutropenia  1  7/46 (15.22%)  7
Eye disorders   
Oedema  1  1/46 (2.17%)  1
General disorders   
Fatigue  1  3/46 (6.52%)  3
Infections and infestations   
Fever  1  1/46 (2.17%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oblimersen + Rituximab
Affected / at Risk (%) # Events
Total   46/46 (100.00%)    
Blood and lymphatic system disorders   
Anaemia  1 [1]  23/46 (50.00%)  23
Thrompbocytopenia  1 [2]  8/46 (17.39%)  8
Neutropenia  1 [2]  3/46 (6.52%)  3
Eye disorders   
Odema  1 [2]  9/46 (19.57%)  9
Gastrointestinal disorders   
Fatigue  1 [2]  17/46 (36.96%)  17
Infections and infestations   
Fever  1 [2]  5/46 (10.87%)  5
Skin and subcutaneous tissue disorders   
Rash  1 [2]  9/46 (19.57%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
[1]
Grade 1 and 2
[2]
Grades 1 and 2
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 Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anas Younes, MD / Professor
Organization: UT MD Anderson Cancer Center
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00054639    
Obsolete Identifiers: NCT01654952
Other Study ID Numbers: NCI-2011-00617
ID02-148
N01CM17003 ( U.S. NIH Grant/Contract )
N01CM62202 ( U.S. NIH Grant/Contract )
N01CM17107 ( U.S. NIH Grant/Contract )
N01CM62203 ( U.S. NIH Grant/Contract )
First Submitted: February 5, 2003
First Posted: February 6, 2003
Results First Submitted: January 24, 2011
Results First Posted: February 21, 2011
Last Update Posted: May 28, 2014