Ziftomenib + Mezigdomide in Adolesc. and Adults w/ R/R AML

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07355335
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • KMT2A-rearranged
  • NPM1-mutant Refractory or Relapsed AML

Eligibility Criteria

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

Interventions

  • Ziftomenib — DRUG
    Capsule taken orally once daily on days 1-28 of each 28-day cycle.
  • Mezigdomide — DRUG
    Capsule taken orally once daily on days 1-21 or possibly days 1-14 of each 28-day cycle.

Study Details

The purpose of this study is to evaluate the safety and tolerability of mezigdomide in combination with ziftomenib in adolescent and adult participants with either KMT2A-rearranged (KMT2A-r) or NPM1-mutant relapsed or refractory acute myeloid leukemia (AML).

Key Dates

Start date
Jul 9, 2026
Status verified
Jan 2026
Primary completion
Jul 1, 2027
Completion
Jan 1, 2028

Study Design

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

Arms

  • Experimental: Ziftomenib and Mezigdomide
    Ziftomenib will be taken orally once daily of each cycle. A drug diary will be provided to participants to document information about taking ziftomenib. Mezigdomide will be taken orally once daily on days 1-21 or possibly days 1-14 of each cycle. The study doctor will confirm which days mezigdomide will be taken on. A drug diary will be provided to participants to document information about taking mezigdomide.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: From the start of treatment until participant withdrawal, death, or removal from study, whichever comes first, assessed up to 2 years after initial dose of study treatment. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Richard Stone, MD
[email protected]
617-632-2214
Wallace Bourgeois, MD
[email protected]
617-525-4134
Richard Stone, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Amir Fathi, MD
[email protected]
617-724-1124
Amir Fathi, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Dana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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