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Phase I/II Study of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide

NCT01458366 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-04-30

Study results available
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Summary

The 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.

Conditions

  • Non-Hodgkin's Lymphoma

Interventions

DRUG

Bendamustine

Phase 1: Given via IV at the following dose levels: * Level 1: 70 mg/m2 * Level -1: 50 mg/m2 * Level 2: 90 mg/m2 * Level 3: 120 mg/m2 Phase II: Given via IV on Days 1 and 2 of each cycle at the maximum-tolerated dose level found in the Phase I portion of the study.

DRUG

Ofatumumab

Phase II * Cycle 1: 300 mg via IV on Day 1 and 1000 mg via IV on Day 3 * Cycles 2 and 3: 1000 mg via IV on Day 1

DRUG

Carboplatin

Phase II: AUC 5 via IV on Day 2 of each cycle

DRUG

Etoposide

Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle

PROCEDURE

CT Scan

CT Scan to assess disease after Cycle 2 (approximately 25 days) and 3-8 weeks post-treatment

PROCEDURE

PET Scan

PET Scan to assess disease after Cycle 2 (approximately 25 days) and 3-8 weeks post-treatment

GENETIC

Stem Cell Transplant (STC)

For potential transplant candidates: * Autologous STC: after 2 cycles of BOCE upon discretion of Thomas Jefferson University hematopoietic stem cell transplant group and in agreement with the study PI or her designee * Allogeneic STC: after 2 cycles of BOCE upon discretion of Thomas Jefferson University hematopoietic stem cell transplant group and in agreement with the study PI or her designee

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Joanne Filicko-O'Hara, MD · Sidney Kimmel Cancer Center at Thomas Jefferson University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-09
Primary Completion
2018-08-27
Completion
2020-07-23

Countries

  • United States

Study Locations

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Entities

Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01458366 on ClinicalTrials.gov