RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Daiichi Sankyo • ClinicalTrials.gov ID: NCT06824168

Registry updated: 2026-09-16

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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).

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

Eligibility criteria

Key Inclusion 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. Complete blood count recovery is required with absolute neutrophil count of more than 1.000 × 109/L and platelets more than 100 × 109/L (IWG criteria).27 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. Participants who received FLT3 inhibitors before enrollment in the trial will need a washout period of 14 days. 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. Key Exclusion Criteria: 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

Conditions

Acute Myeloid Leukemia Leukemia

Locations

University of Alabama - Birmingham — Birmingham, Alabama, United States
USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
John Hopkins School of Medicine — Baltimore, Maryland, United States
Umass Memorial Health Care Systems — Worcester, Massachusetts, United States
John Theurer Cancer Center at Hackensack UMC — Hackensack, New Jersey, United States
Roswell Park Cancer Institute — Buffalo, New York, United States
Weill Cornell — New York, New York, United States
Westchester Medical College — Valhalla, New York, United States
Clinical Research Allicance — Westbury, New York, United States
Novant Health Clinical Research — Charlotte, North Carolina, United States
East Carolina University — Greenville, North Carolina, United States
Spoknwrd Clinical Trials Inc. — Easton, Pennsylvania, United States
The Methodist Hospital Research Institute — Houston, Texas, United States
The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Huntsman Cancer Institute — Salt Lake City, Utah, United States
Royal Adelaide Hospital — Adelaide, Australia
Austin Health — Australia, Australia
St. Vincent's Hospital Melbourne — Darlinghurst, Australia
The Alfred Hospital — Melbourne, Australia
Royal Perth Hospital — Perth, Australia
Gold Coast University Hospital — Southport, Australia
Westmead Hospital — Sydney, Australia
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer — Curitiba, Brazil
Cetus Hospital Dia Oncologia — Minas Gerai, Brazil
Hospital de Clínicas de Porto Alegre — Porto Alegre, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre Centro Multidisciplinar de Pesquisa — Porto Alegre, Brazil
INCA - Instituto Nacional de Câncer — Rio de Janeiro, Brazil
"Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto CIP - Centro Integrado de Pesquisa" — San Jose Rio Preto, Brazil
Hospital Santa Marcelina — São Paulo, Brazil
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira — São Paulo, Brazil
Peking Union Medical College Hospital — Beijing, China
Peking University Third Hospital — Beijing, China
The First Hospital of Jilin University — Changchun, China
Guangdong Provincial People's Hospital — Guangzhou, China
Nanfang Hospital of Southern Medical University — Guangzhou, China
Sun Yat-sen University Cancer center — Guangzhou, China
The First Affiliated Hosptial of Zhejiang University School of Medicine — Hangzhou, China
The First Affiliated Hospital of Nanchang University — Nanchang, China
Zhong Da Hospital, Southeast University — Nanjing, China
The First Affiliated Hospital of Guangxi Medical University — Nanning, China
The Affiliated Hospital of Qingdao University — Qingdao, China
Huashan Hospital, Fudan University — Shanghai, China
The First Affiliated Hospital of Soochow University — Suzhou, China
Hematology Hospital of the Chinese Academy of Medical Sciences — Tianjin, China
The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, China
The First Affiliated Hospital of Jiaotong University — Xi'an, China
The First Affiliated Hospital of Xiamen University — Xiamen, China
The Affiliated Hospital of Xuzhou Medical College — Xuzhou, China
The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China
Inje University Haeundae Paik Hospital — Busan, South Korea
Pusan National University Hospital — Busan, South Korea
Kyungpook National University Hospital — Daegu, South Korea
Yeungnam University Hospital — Daegu, South Korea
National Cancer Center — Goyang-si, South Korea
Gachon University Gil Medical Center — Incheon, South Korea
Jeonbuk National University Hospital — Jeonju, South Korea
Seoul National University Bundang Hospital — Seongnam, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul, South Korea
Samsung Medical Center — Seoul, South Korea
Seoul National University Hospital — Seoul, South Korea
Severance Hospital, Yonsei University Health System — Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul, South Korea
Ajou University Hospital — Suwon, South Korea
Ulsan University Hospital — Ulsan, South Korea

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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