Trial Outcomes & Findings for Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma (NCT NCT00054639)

NCT ID: NCT00054639

Last Updated: 2014-05-28

Results Overview

Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: 2 months following study treatment
• Results posted on: 2014-05-28

Participant Flow

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

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.

Participant milestones

Measure	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.
Overall Study STARTED	48
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	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.
Overall Study Lack of Efficacy	1
Overall Study Physician Decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Oblimersen + Rituximab n=46 Participants 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.
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months following study treatment

Population: Analysis was per protocol. Of the 48 participants enrolled, only 42 were evaluable for response.

Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment

Outcome measures

Measure	Oblimersen + Rituximab n=42 Participants 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.
Number of Patients With Objective Response Complete Responses	10 participants
Number of Patients With Objective Response Partial Responses	8 participants

Adverse Events

Oblimersen + Rituximab

Serious events: 15 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Measure	Oblimersen + Rituximab n=46 participants at risk 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.
Blood and lymphatic system disorders Anaemia	2.2% 1/46 • Number of events 1 • 2 Years, 10 Months
Blood and lymphatic system disorders Thrombocytopenia	4.3% 2/46 • Number of events 2 • 2 Years, 10 Months
Blood and lymphatic system disorders Neutropenia	15.2% 7/46 • Number of events 7 • 2 Years, 10 Months
General disorders Fatigue	6.5% 3/46 • Number of events 3 • 2 Years, 10 Months
Eye disorders Oedema	2.2% 1/46 • Number of events 1 • 2 Years, 10 Months
Infections and infestations Fever	2.2% 1/46 • Number of events 1 • 2 Years, 10 Months

Other adverse events

Measure	Oblimersen + Rituximab n=46 participants at risk 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.
Blood and lymphatic system disorders Anaemia	50.0% 23/46 • Number of events 23 • 2 Years, 10 Months
Blood and lymphatic system disorders Thrompbocytopenia	17.4% 8/46 • Number of events 8 • 2 Years, 10 Months
Blood and lymphatic system disorders Neutropenia	6.5% 3/46 • Number of events 3 • 2 Years, 10 Months
Gastrointestinal disorders Fatigue	37.0% 17/46 • Number of events 17 • 2 Years, 10 Months
Eye disorders Odema	19.6% 9/46 • Number of events 9 • 2 Years, 10 Months
Skin and subcutaneous tissue disorders Rash	19.6% 9/46 • Number of events 9 • 2 Years, 10 Months
Infections and infestations Fever	10.9% 5/46 • Number of events 5 • 2 Years, 10 Months

Additional Information

Anas Younes, MD / Professor

UT MD Anderson Cancer Center

Email: CR_Study_Registration@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60