Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide for Refractory or Relapsed Aggressive B-Cell Lymphomas

This study is currently recruiting participants.
Verified August 2012 by Thomas Jefferson University

First Received on September 26, 2011.  
Last Updated on August 7, 2012  
History of Changes
This Clinical Trial Sponsored By: Thomas Jefferson University
Collaborator: GlaxoSmithKline
Information provided by (Responsible Party): Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01458366
 

Purpose for Clinical Trial

The Clinical Trial Phase I part of the study will apply to identify dose-limiting toxicities (DLT) and to define maximum-tolerated dose (MTD) for a new chemoimmunotherapy combination of bendamustine, ofatumumab, carboplatin, and etoposide in patients with Non Hodgkin’s lymphoma whose disease has progressed or has recurred after prior chemotherapy.

The Phase II part of the study will be a single-arm, open-label study in which all patients will receive combination bendamustine, ofatumumab, carboplatin and etoposide at the MTD dose defined in phase I.

This study hopes to identify a life-prolonging therapy for patients with Non-Hodgkin’s Lymphoma whose disease has progressed or has recurred after prior chemotherapy. The hypothesis is that the proposed combination of chemotherapy is well-tolerated and is efficacious for the treatment of relapsed/refractory aggressive B cell lymphomas.

Condition Study Intervention Phase
Non-Hodgkin’s Lymphoma Drug: Bendamustine
Drug: Ofatumumab
Drug: Carboplatin
Drug: Etoposide
Procedure: CT Scan
Procedure: PET Scan
Genetic: Stem Cell Transplant (STC)
Phase 1
Phase 2

Study Type: Study Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide for Refractory or Relapsed Aggressive B-cell Lymphomas

Resource links provided by NLM:

MedlinePlus related topics:
CT Scans
Lymphoma
Nuclear Scans
Drug Information available for:
Bendamustine hydrochloride
Bendamustine
Etoposide
Carboplatin
Etoposide phosphate
Ofatumumab

U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures For Clinical Trial:

  • Phase I: Maximum-Tolerated Dose of Bendamustine in Combination with Ofatumumab, Carboplatin and Etoposide (BOCE) [ Time Frame: Through 50 days ] [ Designated as safety issue: Yes ]
    To determine the maximum-tolerated dose of bendamustine in combination with ofatumumab, carboplatin and etoposide for patients with refractory or relapsed aggressive B cell lymphomas. Toxicity levels will be assessed after every cycle until a dose-limiting toxicity (DLT) is found. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria (CTCAE version 4.0). DLT will be defined as any grade 4 infection, or grade >/= 3 non-hematologic toxicity that persists for 7 days or more.

  • Phase II: Overall Frequency of Response with Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide [ Time Frame: At 25 days and 3-8 weeks post-treatment ] [ Designated as safety issue: No ]
    To determine the overall frequency of response with combination bendamustine, ofatumumab, carboplatin, and etoposide for refractory or relapsed aggressive B-cell lymphomas. Overall response is determined as cumulative Complete Response (CR) and Partial Response (PR).

Secondary Outcome Measures For Clinical Trial:

  • Phase I: Overall Frequency of Response [ Time Frame: CT and PET scans after Cycle 2 (approximately 25 days) and 3-8 weeks post-treatment ] [ Designated as safety issue: No ]
    To determine the overall frequency of response–overall response will include all subjects with complete response (CR) and partial response (PR).

  • Phase II: Complete Response (CR) and Partial Response (PR) Rate [ Time Frame: CT and PET scans after Cycle 2 (approximately 25 days) and 3-8 weeks post-treatment ] [ Designated as safety issue: No ]
    Assessed per the 2007 Revised Cheson Criteria for NHL (33)

  • Phase II: Progression-Free Survival [ Time Frame: At 1 and 2 years ] [ Designated as safety issue: No ]
    To determine 1 and 2 year progression-free survival

  • Phase II: Overall Survival [ Time Frame: At 1 and 2 years ] [ Designated as safety issue: No ]
    To determine 1 and 2 year overall survival.

  • Phase II: Proportion of Patients Who Are Able to Undergo Stem Cell Transplant (SCT) [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
    To determine the proportion of patients who are able to undergo stem cell transplant among transplant-eligible patients. Patients can receive SCT after Cycle 2.

  • Phase II: Safety and Tolerability of the Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide [ Time Frame: After each cycle (after approximately 3 days, 25 days, and 50 days) ] [ Designated as safety issue: Yes ]

    To define safety and tolerability of the combination of ofatumumab, bendamustine, carboplatin and etoposide.

    Determined through dose modifications for bendamustine according to patient’s toxicity levels:

    • Initial 120 mg/m2 dose decreased to 90 mg/m2
    • Initial 90 mg/m2 dose decreased to 70 mg/m2
    • Initial 70 mg/m2 dose decreased to 50 mg/m2
    • Initial 50 mg/m2 dose decreased to Withdrawn from study

Estimated Enrollment: 36
Study Start Date: November 2011
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)

Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
Drug: Bendamustine

Phase 1: Given via IV at the following dose levels:

  • Level 1: 70 mg/m2
  • Level -1: 50 mg/m2

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