Actively Recruiting
Phase 1/2a Study of Durvalumab Combinations With Pralatrexate, Romidepsin, and Oral 5-Azacitidine for Relapsed and Refractory Peripheral T-Cell Lymphoma
Led by University of Virginia · Updated on 2022-03-31
148
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying combinations of the drug durvalumab with pralatrexate, romidepsin, and oral 5-azacitidine to treat patients with peripheral T-cell lymphoma (PTCL), a rare and aggressive type of non-Hodgkin's lymphoma. The study is designed as an open-label Phase 1/2a trial, with an initial phase 1 dose-finding portion followed by a phase 2 portion for the most promising treatments. The goal is to find the highest safe dose and evaluate safety and effectiveness signals for these drug combinations.
CONDITIONS
Brief Title
Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years at the time of signing informed consent
- Histologically confirmed newly diagnosed or relapsed/refractory peripheral T-cell lymphoma according to WHO 2016 criteria
- Patients with relapsed/refractory PTCL who have had at least one previous therapy
- Candidates for stem cell transplantation may receive study drugs as a bridge to transplantation
- Evaluable disease for phase 1 or measurable disease for phase 2
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate organ and bone marrow function, including specified liver enzymes, bilirubin, creatinine, neutrophils, and platelets
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during and after treatment
- Ability to understand and sign informed consent
- Ability to follow study visit schedule and protocol requirements
You will not qualify if you...
- Prior therapy targeting PD-1, PD-L1, or CTLA-4
- For three-drug combinations, prior exposure to two or more drugs in the combination; for two-drug combinations, prior exposure to any of those drugs
- Recent biologic therapy, immunotherapy, chemotherapy, investigational agent, or radiation within 2 weeks before study entry or unresolved side effects
- Use of immunosuppressive medications within 14 days before durvalumab except certain permitted steroids
- Prior allogeneic stem cell transplant
- Allergic reactions to any study drugs or their components
- Gastrointestinal disorders interfering with oral 5-azacitidine absorption
- Use of CYP3A4 inhibitors
- Uncontrolled illnesses
- Specific cardiac abnormalities, including long QT syndrome, recent heart attack, significant ECG abnormalities, heart failure, arrhythmias, uncontrolled hypertension, or coronary artery disease
- Pregnancy or breastfeeding
- Active concurrent cancer except certain skin or cervical conditions
- Solid organ transplant recipients
- Active or recent autoimmune or inflammatory disorders except some stable or mild conditions
- Central nervous system lymphoma involvement
- Active hepatitis A, B, or C infection
- Known HIV infection
- History of primary immunodeficiency
- Receipt of live vaccine within 30 days before study entry or during the study and 30 days after last durvalumab dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Multiple 28-day treatment cycles
Participants receive combinations of durvalumab with pralatrexate, romidepsin, and/or oral 5-azacitidine in 28-day cycles depending on their assigned treatment arm.
Visits on dosing days within each 28-day cycle; schedules vary by treatment arm
Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
A
Abdelmalek Marian
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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