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Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054639
First received: February 5, 2003
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
Results First Received: January 24, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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

  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
Recruitment Period: January 07, 2003 to October 01, 2005. Recruitment was done at UT MD Anderson Cancer Center Clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Oblimersen + Rituximab 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.

Participant Flow:   Overall Study
    Oblimersen + Rituximab  
STARTED     48  
COMPLETED     46  
NOT COMPLETED     2  
Lack of Efficacy                 1  
Physician Decision                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Oblimersen + Rituximab 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.

Baseline Measures
    Oblimersen + Rituximab  
Number of Participants  
[units: participants]
 		  46  
Age  
[units: years]
Median ( Full Range ) 		  59  
  ( 35 to 82 )  
Gender  
[units: participants]
 		 
Female     33  
Male     13  
Region of Enrollment  
[units: participants]
 		 
United States     46  



  Outcome Measures

1.  Primary:   Number of Patients With Objective Response   [ Time Frame: 2 months following study treatment ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


Results Point of Contact:  
Name/Title: Anas Younes, MD / Professor
Organization: UT MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00054639     History of Changes
Obsolete Identifiers: NCT01654952
Other Study ID Numbers: NCI-2011-00617, ID02-148, N01CM17003, N01CM62202, N01CM17107, N01CM62203
Study First Received: February 5, 2003
Results First Received: January 24, 2011
Last Updated: March 11, 2013
Health Authority: United States: Food and Drug Administration