Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma

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 a

Trial Details

NCT ID
NCT03161223
Phase
PHASE1 / PHASE2
Sponsor
University of Virginia
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Durvalumab
  • Pralatrexate
  • Romidepsin
  • 5-Azacitidine
Locations (sample)
  • Charlottesville, Virginia, United States|38.02931,-78.47668

Key Eligibility Criteria

  • Age \>18 years at the time of signing the informed consent
  • Patients must have histologically confirmed newly diagnosed (ND) or Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL) defined according to …
  • Patients with R/R PTCL who have received at least one previous line of therapy are eligible to be enrolled in this study.
  • Patients who are candidate for an autologous or allogeneic stem cell transplantation (SCT) will be allowed to receive the study drugs as a "bridge"…

For full eligibility, visit ClinicalTrials.gov.

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