Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03383575
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia
  • Blasts 20-30 Percent of Bone Marrow Nucleated Cells
  • Chronic Myelomonocytic Leukemia
  • IDH2 Gene Mutation
  • Myelodysplastic Syndrome With Excess Blasts
  • Recurrent High Risk Myelodysplastic Syndrome
  • Refractory High Risk Myelodysplastic Syndrome

Eligibility Criteria

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

Interventions

  • Azacitidine — DRUG
    Given IV or SC
  • Enasidenib — DRUG
    Given PO
  • Quality-of-Life Assessment — OTHER
    Ancillary studies

Study Details

This phase II trial studies the side effects and how well azacitidine and enasidenib work in treating patients with IDH2-mutant myelodysplastic syndrome. Azacitidine and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Jan 17, 2018
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
63 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (enasidenib, azacitidine)
    Patients who are HMA-naive receive enasidenib PO QD on days 1-28 and azacitidine IV over 30-60 minutes or SC on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (enasidenib)
    Patients relapsed and/or refractory to HMA therapy receive enasidenib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 3 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Cleveland Clinic FoundationClevelandOhio44195-
M D Anderson Cancer CenterHoustonTexas77030
Courtney DiNardo
713-794-1141
Courtney DiNardo (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Johns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDCleveland Clinic Foundation· Cleveland, OHM D Anderson Cancer Center· Houston, TX

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