Actively Recruiting
A Phase 2 Study of Enasidenib in IDH2-Mutant Angioimmunoblastic T-Cell Lymphoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-07
25
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating enasidenib as a potential treatment for people with angioimmunoblastic T-cell lymphoma (AITL) that has an IDH2 mutation. This phase 2 study aims to assess the safety of enasidenib when given alone or together with rituximab, focusing on patients whose disease has relapsed or progressed after previous treatments. The study is sponsored by Memorial Sloan Kettering Cancer Center and seeks to improve understanding of treatment options for this lymphoma subtype. Participants will receive oral enasidenib at a dose of 100 mg daily in 28-day cycles. Those who show signs of a co-occurring B-cell lymphoproliferation will also be given intravenous rituximab once weekly for the first month, then monthly for three more months, totaling four months of rituximab treatment. If B-cell proliferation continues after this period, monthly rituximab will be extended until no evidence of proliferation remains. During the study, participants will undergo regular assessments to monitor response and safety, including evaluation of disease status and side effects. The main outcome measured is the response rate at one year. Women of reproductive potential and men will follow specific guidelines for contraception. The total duration of participation depends on treatment response and safety monitoring, with adherence to scheduled visits and protocol requirements throughout the study.
CONDITIONS
Brief Title
A Study of Enasidenib in People With T-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent or enrollment
- Freely given written informed consent to participate
- Pathologically confirmed angioimmunoblastic T-cell lymphoma (AITL) with confirmed IDH2 mutation
- Disease relapsed or progressed after at least one systemic therapy for relapsed/refractory patients
- Discontinued previous systemic anti-cancer therapy for AITL at least 2 weeks or 5 half-lives before treatment
- Performance status of 2 or better on ECOG scale
- Meets laboratory criteria including neutrophil count, platelet count, kidney function, and liver function as specified
- Measurable disease by accepted lymphoma classification or detectable atypical T lymphocytes
- Women of reproductive potential must have negative pregnancy test and agree to use birth control during and 30 days after study
- Women must agree not to breastfeed during study
- Male participants must agree to abstain or use contraception with partners during study and for 4 months after last treatment
- Willing and able to follow study visit schedule and protocol requirements
You will not qualify if you...
- Any serious medical condition, lab abnormality, or psychiatric illness preventing informed consent
- On immunosuppressive therapy after allogeneic stem cell transplant or with significant graft-versus-host disease
- Persistent non-hematologic toxicities greater than grade 1 from prior therapies except alopecia or neuropathy
- Pregnant women
- History of chronic liver disease, veno-occlusive disease, or alcohol abuse
- Received live vaccine within 6 weeks before first dose
- Prior surgery or gastrointestinal conditions affecting drug absorption
- HIV infection with detectable viral load, low CD4 count, or not on antiretroviral medications
- Chronic hepatitis B or C infection as defined with specific testing and treatment requirements
- Active cytomegalovirus infection requiring therapy
- Receiving treatment for another primary cancer except certain lymphoma types and early skin cancers
- Known central nervous system or meningeal involvement by AITL
- Active uncontrolled systemic infections
- Significant active heart disease within 6 months prior to study
- Prior use of enasidenib
- Use of certain medications with narrow therapeutic ranges unless safely adjusted
- Use of digoxin or rosuvastatin requiring counseling or exclusion
- Use of medications that are substrates for UGT1A1 without dose adjustment and monitoring
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 - 28-day cycles with rituximab treatment lasting at least 4 months and continuing as needed
Participants receive oral enasidenib daily on 28-day cycles. Those with co-occurring B-cell lymphoproliferation also receive IV rituximab weekly for the first month, then monthly for three more months. If B-cell proliferation persists, rituximab continues monthly until resolved.
Weekly rituximab visits for 4 weeks, then monthly visits for at least 3 months; daily enasidenib taken at home
Trial Site Locations
Total: 8 locations
1
Dana Farber Cancer Institute (Data Collection Only)
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
2
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Cancer Center (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
4
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
5
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
6
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, United States, 11725
Actively Recruiting
7
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, United States, 10604
Actively Recruiting
8
Memorial Sloan Kettering Nassau (Limited protocol activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
Z
Zachary Epstein-Peterson, MD
S
Steven Horwitz, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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