At a glance
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Phase I/II Study of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide for Refractory or Relapsed Aggressive B-cell Lymphomas
In Brief
A Phase 2 clinical trial evaluating Bendamustine, Ofatumumab, and 5 other interventions for Non-Hodgkin's Lymphoma. Completed, enrolled 38 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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
Phase II: AUC 5 via IV on Day 2 of each cycle
Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle
CT Scan to assess disease after Cycle 2 (approximately 25 days) and 3-8 weeks post-treatment
PET Scan to assess disease after Cycle 2 (approximately 25 days) and 3-8 weeks post-treatment
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