Bendamustine Combined With Rituximab for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (904)

April 18, 2016 updated by: Pharmatech
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Pharmatech Oncology Study Site
      • Fountain Valley, California, United States, 92708
        • Pharmatech Oncology Study Site
      • Oxnard, California, United States, 93030
        • Pharmatech Oncology Study Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Pharmatech Oncology Study Site
      • Washington, District of Columbia, United States, 20422
        • Pharmatech Oncology Study Site
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Pharmatech Oncology Study Site
      • Brooksville, Florida, United States, 34613
        • Pharmatech Oncology Study Site
      • Gainesville, Florida, United States, 32605
        • Pharmatech Oncology Study Site
      • Titusville, Florida, United States, 32796
        • Pharmatech Oncology Study Site
    • Illinois
      • Joliet, Illinois, United States, 60435
        • Pharmatech Oncology Study Site
    • Indiana
      • Lafayette, Indiana, United States, 47904
        • Pharmatech Oncology Study Site
      • Muncie, Indiana, United States, 47303
        • Pharmatech Oncology Study Site
    • Iowa
      • Dubuque, Iowa, United States, 52001
        • Pharmatech Oncology Study Site
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Pharmatech Oncology Study Site
    • Maine
      • York, Maine, United States, 03909
        • Pharmatech Oncology Study Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Pharmatech Oncology Study Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Pharmatech Oncology Study Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • Pharmatech Oncology Study Site
      • Phillipsburg, New Jersey, United States, 08865
        • Pharmatech Oncology Study Site
    • New York
      • Bay Shore, New York, United States, 11706
        • Pharmatech Oncology Study Site
      • Bronx, New York, United States, 10467
        • Pharmatech Oncology Study Site
      • East Setauket, New York, United States, 11733
        • Pharmatech Oncology Study Site
    • Ohio
      • Akron, Ohio, United States, 44304
        • Pharmatech Oncology Study Site
      • Columbus, Ohio, United States, 43219
        • Pharmatech Oncology Study Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Pharmatech Oncology Study Site
      • Gettysburg, Pennsylvania, United States, 17325
        • Pharmatech Oncology Study Site
    • South Carolina
      • Hilton Head, South Carolina, United States, 29926
        • Pharmatech Oncology Study Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Pharmatech Oncology Study Site
    • Texas
      • Austin, Texas, United States, 78759
        • Pharmatech Oncology Study Site
      • Corpus Christi, Texas, United States, 78463
        • Pharmatech Oncology Study Site
      • Fort Worth, Texas, United States, 76104
        • Pharmatech Oncology Study Site
      • Lubbock, Texas, United States, 79410
        • Pharmatech Oncology Study Site
      • Richardson, Texas, United States, 75080
        • Pharmatech Oncology Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)
    • Hemoglobin ≥ 8 g/dL
    • Creatinine ≤ 2.0 mg/dL or Creatinine Clearance ≥ 50 mL/min (calculated or 24-hr urine sample)
    • AST/SGOT 2.0 x ULN (≤ 5.0 x ULN if secondary to liver metastases)
    • ALT/SGPT 2.0 x ULN (≤ 5.0 x ULN if secondary to liver metastases)
    • Total bilirubin ≤ 2.0 x ULN

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 1. 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 1.
  • Prior radioimmunotherapy (i.e. Zevalin®) within 10 weeks of Cycle 1, Day 1
  • Prior use of investigational anti-cancer agents within 28 days of Cycle 1, Day 1
  • Unresolved toxicities ≥ grade 2 from previous therapy
  • Pregnant or lactating females. Females of childbearing potential (FCBP) and non-vasectomized men must agree to use effective methods of birth control during and 28 days following treatment period. FCBP must have a negative pregnancy test.
  • HIV-related lymphoma
  • Known active HIV or HCV infection, or known seropositivity for HIV, or current or chronic HBV or HCV infection. HBV test required at screening or within 6 months of screening and must indicate negative result. Patients with seropositivity presumed to be due to prior vaccination against Hepatitis B or resolved infection are not excluded (see HBV reactivation guidelines included in rituximab prescribing information).
  • Concurrent active or history of other malignancies, except nonmelanoma skin cancer or carcinoma in situ of cervix or breast. Patients with previous malignancies are eligible provided they have been disease free for ≥ 1 year.
  • Serious (grade 3-4), active, intercurrent infection requiring therapy, or deep seated or systemic mycotic infections
  • Myocardial infarction within 6 months prior to registration or New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or significant conduction system abnormalities, in the judgment of the Investigator
  • Thyroid disease in which thyroid function cannot be maintained within normal range, in the judgment of the Investigator
  • Concurrent uncontrolled serious medical or psychiatric conditions likely to interfere with participation in this clinical study, in the judgment of the Investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bendamustine with rituximab
All patients received combination bendamustine with rituximab
Drug: bendamustine
120 mg/m2 IV, Days 1, 2 of Cycles 1-6
Other Names:
  • Treanda
Drug: rituximab
375 mg/m2 IV, Day 1 of Cycles 1-6
Other Names:
  • Rituxan

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmatech

Collaborators

Cephalon

Investigators

  • Principal Investigator: Jeffrey L Vacirca, MD, FACP, University Hospital, Stony Brook North Shore Hematology/Oncology Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

January 26, 2009

First Submitted That Met QC Criteria

January 27, 2009

First Posted (Estimate)

January 29, 2009

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-08904
  • IND Exemption Number 103985

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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