38
Participants
Start Date
November 9, 2011
Primary Completion Date
August 27, 2018
Study Completion Date
July 23, 2020
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."
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"
Carboplatin
Phase II: AUC 5 via IV on Day 2 of each cycle
Etoposide
Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle
CT Scan
CT Scan to assess disease after Cycle 2 (approximately 25 days) and 3-8 weeks post-treatment
PET Scan
PET Scan to assess disease after Cycle 2 (approximately 25 days) and 3-8 weeks post-treatment
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"
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia
Collaborators (2)
GlaxoSmithKline
INDUSTRY
Novartis
INDUSTRY
Sidney Kimmel Cancer Center at Thomas Jefferson University
OTHER