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https://pubmed.ncbi.nlm.nih.gov/40932107Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID04747236
Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
Led by University of Virginia · Updated on 2026-01-21
50
Participants Needed
6
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
C
Celgene
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether the combination of oral azacytidine and romidepsin is safe and effective for patients with relapsed or refractory Peripheral T-Cell Lymphoma (PTCL), a rare and aggressive type of non-Hodgkin lymphoma originating from mature T-lymphocytes and NK cells. This Phase IIB trial compares this combination treatment to several single-agent drugs already used for PTCL, known as investigator's choice (IC), including romidepsin, belinostat, pralatrexate, or gemcitabine. The study aims to estimate progression-free survival among patients receiving the combination versus single agents. Participants are randomly assigned to one of two groups: the experimental group receives oral azacytidine (300 mg daily on days 1-14) plus intravenous romidepsin (14 mg/m2 over 4 hours on days 8, 15, and 22) in a 35-day cycle. The comparator group receives one of the investigator's choice drugs, including romidepsin, belinostat, pralatrexate, or gemcitabine, administered according to their standard dosing schedules. The dosing and schedule for the combination have been established from an earlier Phase I trial. During the study, participants will undergo regular assessments to monitor disease progression, response to treatment, and safety. Researchers will measure progression-free survival up to 72 weeks, along with overall survival, response rates, duration of response, time to progression, and frequency of adverse events. Safety will be monitored from consent until 90 days after the last treatment dose, with follow-up continuing on average for 18 months. Participants will have clinical evaluations, imaging, and laboratory tests carried out at scheduled visits throughout the trial.
CONDITIONS
Brief Title
Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed relapsed or refractory peripheral T-cell lymphoma following one prior systemic therapy
- No more than 3 prior therapy lines, including stem cell transplant counting as one line
- Patients with anaplastic large cell lymphoma must have received brentuximab vedotin before enrollment
- Measurable disease according to study definitions
- Age 18 years or older
- ECOG performance status 0, 1, or 2
- Adequate organ and marrow function including specific blood counts and liver function requirements
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception for females of childbearing potential and male subjects
- Ability and willingness to provide written informed consent or assent
You will not qualify if you...
- Diagnosis of patch/plaque stage mycosis fungoides
- Prior exposure to hypomethylating agents or histone deacetylase inhibitors
- Chemotherapy or radiotherapy within 2 weeks before study entry or unresolved adverse events from earlier treatments
- Unstabilized systemic steroids above prednisone 10 mg/day equivalent
- Use of other investigational agents within 2 weeks of enrollment
- Known central nervous system metastases including lymphomatous meningitis
- Uncontrolled illnesses including active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Nursing women
- Other active cancers except certain skin or in situ carcinomas unless disease-free for 3 years
- HIV-positive status
- Active hepatitis A, B, or C infection
- Use of CYP3A4 inhibitors
- History of inflammatory bowel disease or gastrointestinal disorders affecting drug absorption or risk
- Abnormal blood clotting unless due to anticoagulation treatment
- Known allergy or sensitivity to azacitidine or mannitol
- Significant cardiac abnormalities including long QT syndrome, recent heart attack, specific ECG abnormalities, heart failure, arrhythmias, severe hypertension, or use of anti-arrhythmic drugs (except stable beta-blockers)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Treatment
Duration - Up to 72 weeks or until disease progression or discontinuation
Participants receive assigned treatment with either oral Azacytidine plus Romidepsin or one of the investigator's choice drugs for their relapsed or refractory peripheral T-cell lymphoma.
Regular visits for drug administration and assessments as per assigned treatment schedule
Follow-up
Duration - Up to 90 days after the last day of study treatment, with average total study participation around 18 months
Participants are followed for safety monitoring and assessment of treatment outcomes after completing or discontinuing treatment.
Follow-up visits for safety and response assessments
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
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Research Team
C
Craig Portell, MD
M
Marian Abdelmalek, MS
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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