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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00831597
First Posted: January 29, 2009
Last Update Posted: April 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cephalon
Information provided by (Responsible Party):
Pharmatech
  Purpose
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.

Condition Intervention Phase
Diffuse Large B-Cell Lymphoma Drug: bendamustine Drug: rituximab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bendamustine Combined With Rituximab for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Pharmatech:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Duration of Response (DOR) [ Time Frame: 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 ]
  • Progression-Free Survival (PFS) [ Time Frame: 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 ]
  • Overall Survival (OS) [ Time Frame: 1 year for 1st assessment and then 2.5 years for final assessment ]

Enrollment: 61
Study Start Date: November 2008
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Treanda
Drug: rituximab
375 mg/m2 IV, Day 1 of Cycles 1-6
Other Name: Rituxan

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
    • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831597


  Show 33 Study Locations
Sponsors and Collaborators
Pharmatech
Cephalon
Investigators
Principal Investigator: Jeffrey L Vacirca, MD, FACP University Hospital, Stony Brook North Shore Hematology/Oncology Associates
  More Information

Additional Information:
Publications:
Responsible Party: Pharmatech
ClinicalTrials.gov Identifier: NCT00831597     History of Changes
Other Study ID Numbers: PI-08904
IND Exemption Number 103985
First Submitted: January 26, 2009
First Posted: January 29, 2009
Last Update Posted: April 19, 2016
Last Verified: May 2012

Keywords provided by Pharmatech:
Lymphoma
B-Cell

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Bendamustine Hydrochloride
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action