Ziftomenib Maintenance Post Allo-HCT

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06440135
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Ziftomenib — DRUG
    Taken orally once per day

Study Details

The purpose of this study is to test the safety, effects, and recommended dose of an investigational drug, ziftomenib, in addition to the standard treatment on blood cancer with Allogeneic Hematopoietic Cell Transplantation (allo-HCT). This study plans to learn more about ziftomenib, which targets and inhibits negative interactions within cancer cells related to AML, when given after allo-HCT, to determine if it improves outcomes following allo-HCT. The name of the study drug involved in this study is: • Ziftomenib

Key Dates

Start date
Jun 11, 2024
Status verified
Mar 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2027

Study Design

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

Arms

  • Experimental: Ziftomenib
    Participants will begin treatment 30 to 90 days after allo-HCT and only after disease remission is confirmed, and treatment will continue for up to 12 months. All participants will receive ziftomenib. Participants will undergo allo-HCT as a part of their standard care. Participants will undergo the following procedures: * Screening * Allo-HCT (standard care), including pre and post-treatment as a part of standard care * 30 - 90 days after allo-HCT, participants will take the study drug orally once per day for up to 12 28-day cycles * End of treatment visit * Follow-up data will be collected every 3 months for 24 months from the start of treatment

Primary Outcome Measure

Maximum Tolerated Dose (Dose Escalation) [ Time Frame: 28 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Zachariah DeFilipp, MD
[email protected]
(617) 726-5765
Ohio State University Wexner Medical Center- James Cancer HospitalColumbusOhio43210
Hannah Choe, MD
[email protected]
614-293-7526
Hannah Choe, MD (PRINCIPAL_INVESTIGATOR)

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