Enasidenib (AG-221) Maintenance Post Allogeneic HCT in Patients With IDH2 Mutation

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT03728335
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Enasidenib Mesylate — DRUG
    Given PO

Study Details

This phase II trial studies the side effects of using enasidenib as maintenance therapy in treating patients with acute myeloid leukemia with IDH2 mutation following donor stem cell transplant. Enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Jul 11, 2019
Status verified
May 2026
Primary completion
Jan 11, 2027
Completion
Jan 11, 2027

Study Design

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

Arms

  • Experimental: Treatment (enasidenib mesylate)
    Patients receive enasidenib PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: Up to 30 days post treatment completion ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Amandeep Salhotra
[email protected]
626-218-2405
Amandeep Salhotra (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612-

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope Medical Center· Duarte, CAMoffitt Cancer Center· Tampa, FL

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