Actively Recruiting
Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma
Led by University of Virginia · Updated on 2022-03-31
148
Participants Needed
1
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 greater than 18 years at the time of signing informed consent
- Histologically confirmed newly diagnosed or relapsed/refractory peripheral T-cell lymphoma per 2016 WHO criteria
- Patients with relapsed/refractory PTCL who have had at least one prior treatment
- Candidates for autologous or allogeneic stem cell transplant may receive study drugs as a bridge to transplant
- Evaluable disease for phase 1 or measurable disease for phase 2
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate organ and marrow function including liver enzymes, bilirubin, creatinine, neutrophil and platelet counts
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during treatment and specified periods after
- Ability to understand and sign informed consent
- Ability to follow study visit schedule and protocol requirements
You will not qualify if you...
- Prior treatment with agents targeting PD-1, PD-L1, or CTLA-4
- For three-drug arms, prior exposure to at least two of those drugs; for two-drug arms, no prior exposure to those drugs
- Biologic therapy, immunotherapy, chemotherapy, investigational agent, or radiation therapy within 2 weeks before study entry or unresolved side effects above grade 1
- Use of immunosuppressive medication within 14 days before first dose of durvalumab except specific exceptions
- Prior allogeneic stem cell transplant
- Allergic reactions to study drugs or their components
- Gastrointestinal disorders interfering with oral 5-azacitidine absorption
- Use of CYP3A4 inhibitors
- Uncontrolled illnesses
- Specific cardiac conditions for patients receiving romidepsin including long QT syndrome, significant QT prolongation, recent myocardial infarction, serious ECG abnormalities, symptomatic coronary artery disease, congestive heart failure, ventricular arrhythmias, hypertrophic cardiomyopathy, uncontrolled hypertension, or arrhythmias requiring medication
- Pregnancy or breastfeeding
- Active other cancers except certain skin or cervical conditions
- Receipt of solid organ transplant
- Active or recent autoimmune or inflammatory disorders within 3 years with some exceptions
- Central nervous system involvement including lymphomatous meningitis
- Active hepatitis A, B, or C infection
- Known HIV infection
- History of primary immunodeficiency
- Receipt of live vaccines within 30 days before study entry or during study and 30 days after last durvalumab dose
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
A
Abdelmalek Marian
CONTACT
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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