RECRUITING

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

Conditions

Acute Myeloid Leukemia Leukemia quizartinib FLT3 allo-HSCT

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 2, Multicenter, Randomized, Open-label Trial to Evaluate Safety and Efficacy of Two Dose Levels of Quizartinib as Maintenance for Adult Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia in Complete Remission

Quick Facts

Study Start:2025-07-18

Study Completion:2032-07-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06824168

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adults ≥18 years of age or the minimum legal adult age (whichever is greater) on the day of signing the ICF (no upper limit of age). 2. Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm based on the World Health Organization (WHO) 2008/2016 classification. 3. Participant has confirmed FLT3-ITD-positive (≥0.05 SR or ≥5% VAF) activating mutation from initial diagnosis in bone marrow or peripheral blood as determined by a local institution's validated molecular testing. 4. Participants must have confirmed, morphologically documented CR1, on the most recent BMA, based on the local laboratory results, performed within 28 days prior to C1D1 of maintenance therapy. Complete remission will be defined as \<5% blasts in the bone marrow with no morphologic characteristics of acute leukemia (e.g., Auer Rods), no evidence of extramedullary disease, and no leukemic blasts in the peripheral blood. 5. Participant must meet the following prior therapy requirements: 1. Has received at least one cycle of induction therapy but no more than two to achieve CR1. The induction cycles can be the same regimen or different regimens and may contain conventional agents only (e.g., cytarabine + daunorubicin or idarubicin: "7 + 3" or "5 + 2"), or a combination with FLT3 inhibitors. 2. Has not received more than four cycles of consolidation therapy. Regimens may contain conventional agents only. 3. FLT3 inhibitors are permitted as part of the induction or consolidation treatment. 6. Able to begin the maintenance phase within 60 days of D1 of the last consolidation cycle received. 7. Eastern Cooperative Oncology Group (ECOG) PS of 0 to 2.	1. Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (i.e., chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy). 2. Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms. 3. Prior treatment for AML, except for the following allowances: 1. Induction and consolidation therapy, as previously described (inclusion criterion #5) 2. Leukapheresis 3. Hydroxyurea to treat hyperleukocytosis 4. Cranial radiotherapy for central nervous system (CNS) leukostasis 5. Prophylactic intrathecal chemotherapy 6. Growth factor/cytokine support 4. Participant had received allo-HSCT as part of AML treatment. 5. Treatment with any strong or moderate CYP3A inducers within 2 weeks or 5 half-lives of randomization whichever is longer 6. Uncontrolled or significant cardiovascular disease, including the following: 1. QTcF interval \>450 ms (based on average of triplicate ECG at Screening) 2. Diagnosed or suspected congenital long QT syndrome or known family history of congenital long QT syndrome 3. History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes 4. Participant has bradycardia of less than 50 beats per minute (bpm; as determined by central reading), unless the participant has a pacemaker 5. History of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers. 6. Myocardial infarction within 6 months prior to screening 7. Uncontrolled angina pectoris within 6 months prior to screening 8. New York Heart Association Class 3 or 4 congestive heart failure 9. LVEF ≤45% or institutional lower limit of normal 10. Uncontrolled hypertension (resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg despite optimal medical management) 11. Complete left or right bundle branch block 12. Severe aortic stenosis

Inclusion Criteria

Exclusion Criteria

1. Adults ≥18 years of age or the minimum legal adult age (whichever is greater) on the day of signing the ICF (no upper limit of age).
2. Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm based on the World Health Organization (WHO) 2008/2016 classification.
3. Participant has confirmed FLT3-ITD-positive (≥0.05 SR or ≥5% VAF) activating mutation from initial diagnosis in bone marrow or peripheral blood as determined by a local institution's validated molecular testing.
4. Participants must have confirmed, morphologically documented CR1, on the most recent BMA, based on the local laboratory results, performed within 28 days prior to C1D1 of maintenance therapy. Complete remission will be defined as \<5% blasts in the bone marrow with no morphologic characteristics of acute leukemia (e.g., Auer Rods), no evidence of extramedullary disease, and no leukemic blasts in the peripheral blood.
5. Participant must meet the following prior therapy requirements:
1. Has received at least one cycle of induction therapy but no more than two to achieve CR1. The induction cycles can be the same regimen or different regimens and may contain conventional agents only (e.g., cytarabine + daunorubicin or idarubicin: "7 + 3" or "5 + 2"), or a combination with FLT3 inhibitors.
2. Has not received more than four cycles of consolidation therapy. Regimens may contain conventional agents only.
3. FLT3 inhibitors are permitted as part of the induction or consolidation treatment.
6. Able to begin the maintenance phase within 60 days of D1 of the last consolidation cycle received.
7. Eastern Cooperative Oncology Group (ECOG) PS of 0 to 2.

1. Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (i.e., chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
2. Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms.
3. Prior treatment for AML, except for the following allowances:
1. Induction and consolidation therapy, as previously described (inclusion criterion #5)
2. Leukapheresis
3. Hydroxyurea to treat hyperleukocytosis
4. Cranial radiotherapy for central nervous system (CNS) leukostasis
5. Prophylactic intrathecal chemotherapy
6. Growth factor/cytokine support
4. Participant had received allo-HSCT as part of AML treatment.
5. Treatment with any strong or moderate CYP3A inducers within 2 weeks or 5 half-lives of randomization whichever is longer
6. Uncontrolled or significant cardiovascular disease, including the following:
1. QTcF interval \>450 ms (based on average of triplicate ECG at Screening)
2. Diagnosed or suspected congenital long QT syndrome or known family history of congenital long QT syndrome
3. History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes
4. Participant has bradycardia of less than 50 beats per minute (bpm; as determined by central reading), unless the participant has a pacemaker
5. History of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers.
6. Myocardial infarction within 6 months prior to screening
7. Uncontrolled angina pectoris within 6 months prior to screening
8. New York Heart Association Class 3 or 4 congestive heart failure
9. LVEF ≤45% or institutional lower limit of normal
10. Uncontrolled hypertension (resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg despite optimal medical management)
11. Complete left or right bundle branch block
12. Severe aortic stenosis

Contacts and Locations

Study Contact

Contact for Trial Information

CONTACT

908-992-6400

CTRinfo_us@daiichisankyo.com

Study Locations (Sites)

John Hopkins School of Medicine

Baltimore, Maryland, 21287

United States

Umass Memorial Health Care Systems

Worcester, Massachusetts, 01655

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Weill Cornell

New York, New York, 10021-9800

United States

Westchester Medical College

Valhalla, New York, 10595

United States

Clinical Research Allicance

Westbury, New York, 11590

United States

Spoknwrd Clinical Trials Inc.

Easton, Pennsylvania, 18045

United States

The Methodist Hospital Research Institute

Houston, Texas, 77030

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Daiichi Sankyo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-18

Study Completion Date2032-07-14

Study Record Updates

Study Start Date2025-07-18

Study Completion Date2032-07-14

Terms related to this study

Keywords Provided by Researchers

acute myeloid leukemia
quizartinib
FLT3
allo-HSCT
leukemia

Additional Relevant MeSH Terms

Acute Myeloid Leukemia
Leukemia