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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

November 9, 2011

Primary Completion Date

August 27, 2018

Study Completion Date

July 23, 2020

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"

Trial Locations (1)

19107

Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

Novartis

INDUSTRY

lead

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

NCT01458366 - Phase I/II Study of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide | Biotech Hunter | Biotech Hunter