Actively Recruiting
A Study of Enasidenib in People With T-Cell Lymphoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-07
25
Participants Needed
8
Research Sites
153 weeks
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
The researchers are doing this study to find out whether enasidenib is a safe treatment for people with angioimmunoblastic T-cell lymphoma (AITL) that has an IDH2 mutation. The researchers will look at the safety of enasidenib when it is given alone or in combination with the drug rituximab.
CONDITIONS
Official 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
- Provided freely given written informed consent
- Pathologically confirmed angioimmunoblastic T-cell lymphoma with IDH2 mutation
- For relapsed or refractory patients, disease must have relapsed or progressed after at least one systemic therapy
- Previous anti-cancer therapy for AITL discontinued at least 2 weeks or 5 half-lives before treatment
- Performance status of 0 to 2 on the ECOG scale
- Laboratory values meeting specified blood counts, kidney function, and liver enzyme limits
- Measurable disease by accepted lymphoma classifications or detectable atypical T lymphocytes
- Women of reproductive potential must have a negative pregnancy test and agree to use adequate birth control during and 30 days after the study
- Women must agree not to breastfeed during the study
- Male subjects must agree to abstain or use effective contraception with partners of childbearing potential during the study and for 4 months after
- Willing and able to follow the study visit schedule and protocol requirements
You will not qualify if you...
- Serious medical condition, laboratory abnormality, or psychiatric illness preventing informed consent
- On immunosuppressive therapy post-allogeneic stem cell transplant or with significant graft-versus-host disease
- Persistent significant toxicities from prior therapies other than alopecia or neuropathy
- Pregnant women
- History of chronic liver disease, veno-occlusive disease, or alcohol abuse
- Received live vaccine within 6 weeks before first study dose
- Prior surgery or gastrointestinal conditions affecting drug absorption
- HIV infection with detectable viral load, low CD4 count, or not on anti-retroviral therapy
- Chronic hepatitis B or C infection not meeting specific criteria
- Active cytomegalovirus infection requiring treatment
- Receiving therapy for other primary malignancies except specific skin cancers or with exceptions after discussion
- Central nervous system or meningeal involvement by AITL
- Active uncontrolled systemic infections
- Significant active cardiac disease within 6 months before treatment
- Prior use of enasidenib
- Taking certain medications with narrow therapeutic ranges that cannot be safely adjusted
- Use of drugs sensitive to P-gp and BCRP transporters without proper management
- Use of medications metabolized by UGT1A1 without dose adjustments or monitoring
AI-Screening
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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
CONTACT
S
Steven Horwitz, MD
CONTACT
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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