RecruitingPhase 2NCT06824168

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

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

Sponsor

Daiichi Sankyo

Enrollment

130 participants

Start Date

Jul 18, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Leukemia

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two different doses of quizartinib as maintenance therapy — treatment given after the main treatment to help prevent relapse — for people with acute myeloid leukemia (AML), a blood cancer, who have a specific FLT3 gene mutation. **You may be eligible if...** - You are 18 or older - You have been diagnosed with AML and have a FLT3-ITD or FLT3-TKD mutation - You have achieved remission (cancer is not detectable) after initial chemotherapy - You did not receive a bone marrow transplant, or you have recovered well from one - Your organ function is within acceptable ranges **You may NOT be eligible if...** - Your leukemia has relapsed or is not in remission - You have serious heart rhythm problems (prolonged QT interval) - You have active serious infections - You are pregnant or breastfeeding - You have received prior quizartinib that your cancer became resistant to Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQuizartinib High Dose

Participants in Arm 1 will receive oral daily higher dose of quizartinib,

DRUGQuizartinib Low Dose

Participants in Arm 2 will receive oral daily lower dose of quizartinib

Locations(58)

John Hopkins School of Medicine

Baltimore, Maryland, United States

Umass Memorial Health Care Systems

Worcester, Massachusetts, 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

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

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

View Full Details on ClinicalTrials.gov

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NCT06824168

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