Actively Recruiting
Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL
Led by University of Virginia · Updated on 2026-01-21
50
Participants Needed
6
Research Sites
484 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
C
Celgene
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to find out whether the combination treatment of romidepsin and oral azacytidine is safe and effective in patients with Peripheral T-Cell Lymphoma (PTCL). This study will compare the experimental combination treatment of romidepsin and oral azacytidine to single agent drugs already determined effective in patients with PTCL. For the purposes of this study, the single agent drugs already used to treat lymphoma are called investigator's choice (IC), meaning the investigator will choose which one of these drugs to administer. The IC drug options include romidepsin, belinostat, pralatrexate or gemcitabine given alone. Funding Source: FDA OOPD.
CONDITIONS
Official Title
Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed relapsed or refractory peripheral T-cell lymphoma as defined by 2016 WHO criteria
- Progression after one prior systemic therapy line
- No more than three prior therapy lines (including cytoreductive therapy plus autologous stem cell transplant counted as one)
- Patients with anaplastic large cell lymphoma must have received brentuximab vedotin before enrollment
- Measurable disease
- Age 18 years or older
- ECOG performance status of 2 or less
- Adequate organ and marrow function, including ANC ≥1000/mm3, platelets >75,000/mm3, creatinine clearance >50 mL/min, bilirubin ≤1.5 x ULN (up to 4x ULN for Gilbert's disease), AST and ALT ≤2 x ULN (or ≤3 x ULN with liver involvement), serum potassium ≥3.8 mmol/L, and serum magnesium ≥1.8 mg/dL
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception for all females of childbearing potential and male subjects
- Willingness and ability to provide written consent or assent
You will not qualify if you...
- Diagnosis of patch/plaque stage mycosis fungoides
- Prior exposure to any hypomethylating agent or histone deacetylase inhibitor (e.g., romidepsin, chidamide, belinostat, vorinostat)
- Chemotherapy or radiotherapy within 2 weeks prior to study or unresolved adverse events from earlier treatments
- Unstable or high-dose systemic steroids (>10 mg/day prednisone equivalent)
- Use of other investigational agents within 2 weeks of enrollment
- Known central nervous system metastases including lymphomatous meningitis
- Uncontrolled illnesses such as active infection, symptomatic congestive heart failure, unstable angina, arrhythmias, or psychiatric/social conditions limiting compliance
- Nursing women
- Other active malignancies except certain skin or cervical/breast in situ cancers or prior malignancy disease-free for 3 years
- HIV positive status
- Active hepatitis A, B, or C infection
- Use of CYP3A4 inhibitors
- History of inflammatory bowel disease, celiac disease, gastrectomy, or gastrointestinal disorders affecting drug absorption or toxicity risk
- Abnormal coagulation parameters unless due to ongoing anticoagulation
- Known or suspected hypersensitivity to azacitidine or mannitol
- Various cardiac abnormalities including long QT syndrome, QTc ≥500 ms, recent myocardial infarction, significant ECG abnormalities, congestive heart failure NYHA Class II-IV, sustained ventricular arrhythmias, hypertrophic or restrictive cardiomyopathy, uncontrolled hypertension, or arrhythmias requiring anti-arrhythmic medications (except stable beta-blockers)
AI-Screening
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Trial Site Locations
Total: 6 locations
1
VA Long Beach Health Care System
Long Beach, California, United States, 90822
Actively Recruiting
2
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
4
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
5
The Ohio State University
Columbus, Ohio, United States, 43210
Not Yet Recruiting
6
University of Virginia
Charlottesville, Virginia, United States, 22911
Actively Recruiting
Research Team
C
Craig Portell, MD
CONTACT
M
Marian Abdelmalek, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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