A Study of Enasidenib in People With T-Cell Lymphoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06756308
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • T-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enasidenib — DRUG
    Enasidenib 100 mg daily on 28-day cycles.
  • Rituximab — DRUG
    IV rituximab 375 mg/m² weekly for the first month, and monthly thereafter on 28-day cycles, for a total of four months of rituximab.

Study Details

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.

Key Dates

Start date
Dec 24, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Enasidenib and rituximab
    Screening Cohort (Non-MSK Patients only) Non-MSK patients will send research tissue samples to MSK for ddPCR analysis to assess IDH2 mutation. Once mutation is confirmed they may be consented to the treatment portion of the trial. All patients will receive oral enasidenib 100 mg daily on 28-day cycles. Patients with evidence of a co-occurring B-cell lymphoproliferation (via tumor morphology, flow cytometry, or B-cell clonality) will be administered IV rituximab 375 mg/m² weekly for the first month, and monthly for 3 months thereafter on 28-day cycles, for a total of four months of rituximab. If B-cell proliferation persists at the end of the 4-month rituximab treatment period, continue treatment with monthly rituximab until no evidence of B-cell lymphoproliferation is seen.

Primary Outcome Measure

response rate [ Time Frame: 1 year ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer Institute (Data Collection Only)BostonMassachusetts02115
Eric D Jacobsen, MD
877-442-3324
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Zachary Epstein-Peterson, MD
646-608-4176
Memorial Sloan Kettering Cancer Center (Limited Protocol Activities)Basking RidgeNew Jersey07920
Zachary Epstein-Peterson, MD
646-608-4176
Memorial Sloan Kettering Monmouth (Limited protocol activities)MiddletownNew Jersey07748
Zachary Epstein-Peterson, MD
646-608-4176
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Zachary Epstein-Peterson, MD
646-608-4176
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)CommackNew York11725
Zachary Epstein-Peterson, MD
646-608-4176
Memorial Sloan Kettering Westchester (All protocol activities)HarrisonNew York10604
Zachary Epstein-Peterson, MD
646-608-4176
Memorial Sloan Kettering Nassau (Limited protocol activities)UniondaleNew York11553
Zachary Epstein-Peterson, MD
646-608-4176

Find similar trials in Boston, MA

By research site
Dana Farber Cancer Institute (Data Collection Only)· Boston, MAMemorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Cancer Center (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited protocol activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk-Commack (Limited protocol activity)· Commack, NY

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