Proteasome Inhibitor PS-341 Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy

Phase 2

Completed

• Conditions: Lymphoma, B-Cell
• Interventions: Drug: PS341 (Bortezomib)

• Registration Number: NCT00038571
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

Purpose of Phase II study for B-cell lymphoma using PS341: Evaluate efficacy and toxicity of bortezomib in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

Detailed Description

Patients were stratified, based on preclinical data, into arm A (mantle-cell lymphoma) or arm B (other B-cell lymphomas) without limitation in number of prior therapies. Bortezomib was administered as an intravenous push (1.5 mg/m2) on days 1, 4, 8, and 11 every 21 days for a maximum of six cycles.

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-05-31
• Study First Submitted QC: 2002-05-31
• Study First Posted: 2002-06-03
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-30
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A (mantle-cell lymphoma)	PS341 (Bortezomib)	-
Arm B (other B-cell lymphomas)	PS341 (Bortezomib)	-

Primary Outcome Measures

Name	Time	Method
Number of Patients with Response to PS-341	Every two 21-day cycles	Patient response evaluated according to criteria of Cheson et al. Endoscopy obtained every two cycles to evaluate response using Complete Response (CR), Partial Response (PR), Progressive Disease, or Stable Disease.

Trial Locations

Locations (1)

UT MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States