Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Daiichi Sankyo
Study ID
NCT06824168
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Quizartinib High Dose — DRUG
    Participants in Arm 1 will receive oral daily higher dose of quizartinib,
  • Quizartinib Low Dose — DRUG
    Participants in Arm 2 will receive oral daily lower dose of quizartinib

Study Details

This clinical two-arm trial is designed to evaluate two doses of quizartinib as maintenance therapy after induction/consolidation in participants with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) (+) acute myeloid leukemia (AML) in first complete remission (CR) who have not received allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Key Dates

Start date
Jul 18, 2025
Status verified
Dec 2025
Primary completion
Jun 6, 2028
Completion
Jul 14, 2032

Study Design

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

Arms

  • Experimental: Arm 1
    Participants will receive higher dose of quizartinib
  • Experimental: Arm 2
    Participants will receive lower dose of quizartinib

Primary Outcome Measure

Serious Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From date of first dose to 30 days after last dose, up to 87 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
John Hopkins School of MedicineBaltimoreMaryland21287-
Umass Memorial Health Care SystemsWorcesterMassachusetts01655-
Roswell Park Cancer InstituteBuffaloNew York14263-
Weill CornellNew YorkNew York10021-9800-
Westchester Medical CollegeValhallaNew York10595-
Clinical Research AllicanceWestburyNew York11590-
Spoknwrd Clinical Trials Inc.EastonPennsylvania18045-
The Methodist Hospital Research InstituteHoustonTexas77030-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Baltimore, MD

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
John Hopkins School of Medicine· Baltimore, MDUmass Memorial Health Care Systems· Worcester, MARoswell Park Cancer Institute· Buffalo, NYWeill Cornell· New York, NYWestchester Medical College· Valhalla, NYClinical Research Allicance· Westbury, NY

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