Ivosidenib as Post-HSCT Maintenance for AML

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Massachusetts General Hospital
Study ID
NCT06707493
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Acute Myeloid Leukemia (AML)
  • Hematopoietic Stem Cell Transplant (HSCT)
  • IDH1 Mutation

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ivosidenib — DRUG
    Ivosidenib tablets are supplied as 50 mg, 200 mg, and 250 mg strengths, to be taken orally.
  • Placebo — DRUG
    Placebo tablets are taken orally.

Study Details

This is a Phase 2 study of the study drug, ivosidenib (a mutant IDH1 inhibitor), compared to placebo, given to patients with IDH1-mutant acute myeloid leukemia (AML) after hematopoietic stem cell transplantation (HCT).

Key Dates

First listed
Nov 27, 2024
Start date
Jan 16, 2026
Status verified
Jun 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2030

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ivosidenib
    After screening and standard of care hematopoietic stem cell transplantation (HCT) and any standard treatment before and after the HSCT, Ivosidenib will be given orally (PO) once daily (QD) in 28-day continuous cycles. Ivosidenib is administered at a pre-determined dose with a goal of 500mg daily. Participants begin study treatment 45 to 90 days after HCT, and treatment will continue for up to 24 months. Study visits and assessments occur throughout study treatment and in follow-up. After the 24-month treatment period, participants are followed for up to 12 additional months.
  • Placebo Comparator: Placebo
    After screening and standard of care hematopoietic stem cell transplantation (HCT) and any standard treatment before and after the HSCT, Placebo will be given orally (PO) once daily (QD) in 28-day continuous cycles. Participants begin study treatment (placebo) 45 to 90 days after HCT, and treatment (placebo) will continue for up to 24 months. Study visits and assessments occur throughout study treatment period and in follow-up. After the 24-month treatment period, participants are followed for up to 12 additional months.

Primary Outcome Measure

Relapse-Free Survival (RFS) [ Time Frame: Time of randomization to 24 months post-randomization, death, or disease relapse whichever occurs first. ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322
Amelia Langston, MD
[email protected]
404-778-0519
Amelia Langston, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
Robert Soiffer, MD
[email protected]
617-632-4731
Robert Soiffer, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Amir T Fathi, MD
[email protected]
617-724-1124
Amir Fathi, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Wexner Medical Center- James Cancer HospitalColumbusOhio43210
Jiasheng Wang, MD
[email protected]
614-293-3196
Jiasheng Wang, MD (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer Institute, University of UtahSalt Lake CityUtah84112
Sagar Patel, MD
[email protected]
801-587-9014
Sagar Patel, MD (PRINCIPAL_INVESTIGATOR)
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226
Sameem Abedin, MD
[email protected]
414-805-4600
Sameem Abedin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Emory University Hospital· Atlanta, GADana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAOhio State University Wexner Medical Center- James Cancer Hospital· Columbus, OHHuntsman Cancer Institute, University of Utah· Salt Lake City, UTFroedtert Hospital & the Medical College of Wisconsin· Milwaukee, WI

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