Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma
Status:
Recruiting
Trial end date:
2021-02-01
Target enrollment:
Participant gender:
Summary
This is an open-label, Phase 1/2a, dose-finding study with an initial phase 1 portion,
articulated in four separate treatment arms, followed by a dedicated phase 2 for qualifying
treatment Arm(s).
The primary objective of the Phase 1 portion is to determine the maximum tolerated dose (MTD)
and dose limiting toxicity (DLT) of the combinations of: Durvalumab, oral 5-azacitidine, and
romidepsin (Arm A); durvalumab, pralatrexate, and romidepsin (Arm B); durvalumab and
romidepsin (Arm C); or durvalumab and oral 5-azacitidine (Arm D), in patients with peripheral
T-cell lymphoma (PTCL). The safety and toxicity profile of these combinations will be
evaluated throughout the entire study.
If one or more of the combinations in Arms A, B, C, or D are found to be feasible and an MTD
is established, the phase 2 portion of the study will be initiated for the combination(s)
with the strongest efficacy signal provided acceptable toxicity.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Columbia University
Collaborators:
Celgene Samsung Medical Center University of Bologna