Bendamustine Combined With Rituximab for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Pharmatech1 site in 1 country61 target enrollmentNovember 2008

ConditionsDiffuse Large B-Cell Lymphoma

Interventionsbendamustine rituximab

Drugsbendamustine rituximab

Overview

Phase: Phase 2
Intervention: bendamustine
Conditions: Diffuse Large B-Cell Lymphoma
Sponsor: Pharmatech
Enrollment: 61
Locations: 1
Primary Endpoint: Best Overall Response Rate (ORR) of bendamustine in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A phase II trial to evaluate the efficacy and safety of combination bendamustine and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. It is hypothesized that the BR combination will produce at least a 70% overall response rate.

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

September 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pharmatech

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed CD20-positive, diffuse large B-cell lymphoma
•Measurable disease with at least one bidimensional lymph node or tumor mass \> 1.5 cm in the longest diameter that can be followed for response as a target lesion as measured by PET or CT
•Relapsed or refractory after at least one prior therapeutic treatment for diffuse large B-cell lymphoma. Relapsed is defined as patients who initially responded and then progressed. Refractory is defined as patients, whom in the judgment of the Investigator, received adequate prior treatment and did not respond during treatment or progressed within 60 days of last treatment. Relapse following an autologous stem cell transplant allowed.
•Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
•Patient must understand and voluntarily sign IRB-approved informed consent
•Life expectancy ≥ three (3) months
•Age ≥ 18 years old
•Laboratory parameters:
•Absolute neutrophil count ≥ 1,000 cells/mm(3)
•Platelet count ≥ 75,000 cells/mm(3)

Exclusion Criteria

•Patients with active/symptomatic central nervous system (CNS) involvement based on clinical evaluation. Previously treated CNS involvement that has remained asymptomatic for ≥ 90 days allowed if no CNS involvement shown by lumbar puncture, PET, CT or MRI.
•Prior treatment with bendamustine
•Known sensitivity to bendamustine or any component of bendamustine
•Known anaphylaxis or immunoglobulin E (IgE) mediated hypersensitivity to murine proteins or sensitivity to rituximab or any component of rituximab
•Eligible for stem cell transplant (patients who refuse procedure will not be excluded)
•Prior allogeneic stem cell transplant within 6 months of Cycle 1, Day 1
•Major surgery, not related to debulking procedures, within 21 days of Cycle 1, Day
•Patients undergoing debulking procedures and minor surgery are allowed after a recovery period, in the judgment of the Investigator.
•Chemotherapy, immunotherapy, or irradiation within 28 days of Cycle 1, Day 1 (within 6 weeks for nitrosoureas or mitomycin). Patients on high dose corticosteroids must have tapered to a stable dose equivalent to Prednisone ≤ 15 mg per day within 28 days of Cycle 1, Day
•Prior radioimmunotherapy (i.e. Zevalin®) within 10 weeks of Cycle 1, Day 1

Arms & Interventions

Bendamustine with rituximab

All patients received combination bendamustine with rituximab

Intervention: bendamustine

Bendamustine with rituximab

All patients received combination bendamustine with rituximab

Intervention: rituximab

Outcomes

Primary Outcomes

Best Overall Response Rate (ORR) of bendamustine in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma

Time Frame: 1 year for 1st assessment and then 2.5 years for final assessment

Secondary Outcomes

Duration of Response (DOR)(1 year for 1st assessment and then 2.5 years for final assessment)
Time to Progression (TTP)(1 year for 1st assessment and then 2.5 years for final assessment)
Safety Profile of Study Treatment(1 year for 1st assessment and then 2.5 years for final assessment)
Overall Survival (OS)(1 year for 1st assessment and then 2.5 years for final assessment)
Progression-Free Survival (PFS)(1 year for 1st assessment and then 2.5 years for final assessment)