RECRUITING

A Study of Enasidenib in People With T-Cell Lymphoma

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Conditions

T-cell LymphomaEnasidenibRituximabIDH2-mutant23-269

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2 Study of Enasidenib in IDH2-Mutant Angioimmunoblastic T-Cell Lymphoma

Quick Facts

Study Start:2024-12-24
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06756308

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically-confirmed AITL at the enrolling institution, with confirmed IDH2 mutation (by MSK ddPCR). For R/R patients, disease must have relapsed or progressed after at least one systemic therapy, diagnostic tumor samples have at least 5% tumor. i) IDH2 hotspot mutation confirmed by CAP/CLIA-certified NGS testing panel. Only cases with confirmed mutations detected \>1% VAF will be eligible.
  2. * Age ≥18 years at time of enrollment Previous systemic anti-cancer therapy for AITL must have been discontinued at least 2 weeks or 5 half-lives (whichever is longer) prior to treatment.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Steven Horwitz, MD
CONTACT
646-608-2680
horwitzs@mskcc.org
Zachary Epstein Peterson, MD
CONTACT
646-608-4176

Principal Investigator

Steven Horwitz, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Dana Farber Cancer Institute (Data Collection Only)
Boston, Massachusetts, 02115
United States
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Cancer Center (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Nassau (Limited protocol activities)
Uniondale, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Steven Horwitz, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-24
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-12-24
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Enasidenib
  • Rituximab
  • IDH2-mutant
  • 23-269

Additional Relevant MeSH Terms

  • T-cell Lymphoma