Phase 1/2a Study of Anti-PD-L1 Monoclonal Antibody Durvalumab in Combination With Pralatrexate and Romidepsin, Oral 5-Aza and Romidepsin, Romidepsin Alone, or Oral 5-Azacitidine for Treatment of Patients With Relapsed and Refractory PTCL

NCT03161223 Phase 1/Phase 2 RECRUITING

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.

Details

Lead sponsor	University of Virginia
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	148
Start date	2018-05-30
Completion	2023-02

Conditions

• Lymphoma, T-Cell

Interventions

• Durvalumab
• Pralatrexate
• Romidepsin
• 5-Azacitidine

Primary outcomes

• Maximum Tolerated Dose (MTD) — 1 year
  The highest dose of study treatment that does not cause unacceptable side effects in patients with R/R PTCL in each study arm

Countries

United States