OncoMatch/Clinical Trials/NCT03161223
Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma
Is NCT03161223 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Durvalumab and Pralatrexate for lymphoma, t-cell.
Treatment: Durvalumab · Pralatrexate · Romidepsin · 5-Azacitidine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: PD-1/PD-L1/CTLA-4 inhibitor
Exposure to any agent targeting PD-1, PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
Cannot have received: study drugs (pralatrexate, romidepsin, oral 5-azacitidine, durvalumab) (pralatrexate, romidepsin, oral 5-azacitidine, durvalumab)
Exception: For three-drug combinations, the patient must not have been exposed to at least two of those drugs. For two drugs combinations patients must not have been exposed to any of those drugs.
For three-drug combinations, the patient must not have been exposed to at least two of those drugs. For two drugs combinations patients must not have been exposed to any of those drugs.
Cannot have received: biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation therapy
Exception: within 2 weeks prior to entering the study or lack of resolution of AE due to previously administered antineoplastic therapy to grade 1 or less
Exposure to biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation therapy within 2 weeks prior to entering the study or lack of resolution of AE due to previously administered antineoplastic therapy to grade 1 or less
Cannot have received: allogeneic stem cell transplant
Prior allogeneic SCT
Lab requirements
Blood counts
ANC > 1,000/μL; platelet count > 75,000/μL
Kidney function
Creatinine < 2 mg/dL; or creatinine clearance > 40 mL/min
Liver function
AST and ALT ≤ 2 x ULN; total bilirubin ≤ 1.5 x ULN (≤ 3 × ULN in subjects with documented Gilbert's syndrome or hyperbilirubinemia clearly attributed to lymphoma involvement of the liver)
Cardiac function
See cardiac exclusion criteria for patients receiving romidepsin
Patients must have adequate organ and marrow function as defined by: AST and ALT ≤ 2 x ULN; total bilirubin ≤ 1.5 x ULN (≤ 3 × ULN in subjects with documented Gilbert's syndrome or hyperbilirubinemia clearly attributed to lymphoma involvement of the liver); Creatinine < 2 mg/dL; or creatinine clearance > 40 mL/min; ANC > 1,000/μL; platelet count > 75,000/μL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Virginia · Charlottesville, Virginia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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