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 Birmingham, Alabama.

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

First listed
Feb 13, 2025
Start date
Jul 18, 2025
Status verified
Sep 2026
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 (15)

FacilityCityStateZIPSite coordinators
University of Alabama - BirminghamBirminghamAlabama35294-
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
John Hopkins School of MedicineBaltimoreMaryland21287-
Umass Memorial Health Care SystemsWorcesterMassachusetts01655-
John Theurer Cancer Center at Hackensack UMCHackensackNew Jersey07601-
Roswell Park Cancer InstituteBuffaloNew York14263-
Weill CornellNew YorkNew York10021-9800-
Westchester Medical CollegeValhallaNew York10595-
Clinical Research AllicanceWestburyNew York11590-
Novant Health Clinical ResearchCharlotteNorth Carolina28204-
East Carolina UniversityGreenvilleNorth Carolina27834-
Spoknwrd Clinical Trials Inc.EastonPennsylvania18045-
The Methodist Hospital Research InstituteHoustonTexas77030-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Birmingham, AL

Nationwide
Leukemia (other) trialsOncology trialsBlood cancer trials
By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Alabama - Birmingham· Birmingham, ALUSC Norris Comprehensive Cancer Center· Los Angeles, CAJohn Hopkins School of Medicine· Baltimore, MDUmass Memorial Health Care Systems· Worcester, MAJohn Theurer Cancer Center at Hackensack UMC· Hackensack, NJRoswell Park Cancer Institute· Buffalo, NY

Related Studies