A Phase I/II Clinical Trial of the Combination of Brentuximab Vedotin and Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma
This is a phase 1/2 open label, multicenter study to assess the safety and efficacy of
brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory
Hodgkin Lymphoma (HL) or other CD30+ expressing hematologic malignancies. Dose escalation in
phase 1 will proceed according to a standard 3 + 3 dose escalation design. There will be no
intracohort dose escalation. Three patients will be assigned to the starting dose level 1.
If no dose limiting toxicities (DLT) are observed after one cycle of treatment, and if the
start of cycle 2 treatment is not delayed greater than 7 days for any toxicity possibly
related to drug, trial accrual proceeds to the next dose level and another cohort of 3
patients is enrolled. If 1 patient in a cohort experiences a DLT, then the cohort is
expanded to 6, if 2 or more patients in this cohort experience a DLT then the dose level
decreases. If none of the additional patients experience a DLT (1 out of 6) then dose
escalation continues. The maximum tolerated dose (MTD) is defined as the highest dose level
at which <33% of the dose cohort (0 of 3 or 1 of 6) experience a DLT in the first cycle.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase 1: Maximum tolerated dose (MTD) of brentuximab vedotin and bendamustine
up to 1.5 years
Yes
Owen A O'Connor, MD, Ph.D.
Principal Investigator
Columbia University
United States: Food and Drug Administration
AAAJ5050
NCT01657331
July 2012
August 2015
Name | Location |
---|---|
Columbia University Medical Center | New York, New York 10032 |