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

NCT06824168 | Recruiting Phase 2 FDA Drug

• 1 other identifier: AC220-167
• Study Type: interventional
• Target: 130
• Locations: 5 countries
• Sites: 58

Brief 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).

Conditions

Acute Myeloid Leukemia; Leukemia

Keywords

acute myeloid leukemia; quizartinib; FLT3; allo-HSCT; leukemia

Outcome Measures

Primary Outcomes (1)

• Serious Treatment Emergent Adverse Events (TEAEs)

  TEAEs are defined as AEs with start or worsening date during the on-treatment period (from the first dose date of trial treatment to 30 days after the last dose date of trial treatment).

  From date of first dose to 30 days after last dose, up to 87 months

Secondary Outcomes (3)

• TEAEs

  From date of first dose to 30 days after last dose, up to 87 months

• Overall Survival (OS)

  From date of randomization to death from any cause, up to 87 months

• Relapse-free Survival (RFS)

  From date of randomization to documented relapse or death from any cause, whichever comes first, up to 87 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Participants will receive higher dose of quizartinib

Drug: Quizartinib High Dose

Arm 2

EXPERIMENTAL

Participants will receive lower dose of quizartinib

Drug: Quizartinib Low Dose

Interventions

Quizartinib Low Dose DRUG

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

Also known as: VANFLYTA®

Arm 2

Quizartinib High Dose DRUG

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

Also known as: VANFLYTA®

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• 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.
• 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
• Participant must meet the following prior therapy requirements:
• 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.
• Has not received more than four cycles of consolidation therapy. Regimens may contain conventional agents only.
• 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.
• Able to begin the maintenance phase within 60 days of D1 of the last consolidation cycle received.
• Eastern Cooperative Oncology Group (ECOG) PS of 0 to 2.

You may not qualify if:

• 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).
• Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms.
• Prior treatment for AML, except for the following allowances:
• Leukapheresis
• Hydroxyurea to treat hyperleukocytosis
• Cranial radiotherapy for central nervous system (CNS) leukostasis
• Prophylactic intrathecal chemotherapy
• Growth factor/cytokine support
• Participant had received allo-HSCT as part of AML treatment.
• Treatment with any strong or moderate CYP3A inducers within 2 weeks or 5 half-lives of randomization whichever is longer
• Uncontrolled or significant cardiovascular disease, including the following:
• QTcF interval \>450 ms (based on average of triplicate ECG at Screening)
• Diagnosed or suspected congenital long QT syndrome or known family history of congenital long QT syndrome
• History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes
• Participant has bradycardia of less than 50 beats per minute (bpm; as determined by central reading), unless the participant has a pacemaker

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (58)

John Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

Umass Memorial Health Care Systems

Worcester, Massachusetts, 01655, United States

WITHDRAWN

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

WITHDRAWN

Weill Cornell

New York, New York, 10021-9800, United States

NOT YET RECRUITING

Westchester Medical College

Valhalla, New York, 10595, United States

WITHDRAWN

Clinical Research Allicance

Westbury, New York, 11590, United States

NOT YET RECRUITING

Spoknwrd Clinical Trials Inc.

Easton, Pennsylvania, 18045, United States

RECRUITING

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Royal Adelaide Hospital

Adelaide, Australia

NOT YET RECRUITING

Austin Health

Australia, Australia

RECRUITING

St. Vincent's Hospital Melbourne

Darlinghurst, Australia

RECRUITING

The Alfred Hospital

Melbourne, Australia

RECRUITING

Royal Perth Hospital

Perth, Australia

NOT YET RECRUITING

Gold Coast University Hospital

Southport, Australia

RECRUITING

Westmead Hospital

Sydney, Australia

RECRUITING

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer

Curitiba, Brazil

RECRUITING

Cetus Hospital Dia Oncologia

Minas Gerai, Brazil

RECRUITING

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil

RECRUITING

Irmandade da Santa Casa de Misericórdia de Porto Alegre Centro Multidisciplinar de Pesquisa

Porto Alegre, Brazil

RECRUITING

INCA - Instituto Nacional de Câncer

Rio de Janeiro, Brazil

RECRUITING

"Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto CIP - Centro Integrado de Pesquisa"

San Jose Rio Preto, Brazil

RECRUITING

Hospital Santa Marcelina

São Paulo, Brazil

RECRUITING

ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

São Paulo, Brazil

RECRUITING

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Peking University Third Hospital

Beijing, China

RECRUITING

The First Hospital of Jilin University

Changchun, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, China

RECRUITING

Nanfang Hospital of Southern Medical University

Guangzhou, China

RECRUITING

Sun Yat-sen University Cancer center

Guangzhou, China

RECRUITING

The First Affiliated Hosptial of Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, China

RECRUITING

Zhong Da Hospital, Southeast University

Nanjing, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, China

RECRUITING

Huashan Hospital, Fudan University

Shanghai, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, China

RECRUITING

Hematology Hospital of the Chinese Academy of Medical Sciences

Tianjin, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

WITHDRAWN

The First Affiliated Hospital of Jiaotong University

Xi'an, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

Inje University Haeundae Paik Hospital

Busan, South Korea

RECRUITING

Pusan National University Hospital

Busan, South Korea

RECRUITING

Kyungpook National University Hospital

Daegu, South Korea

RECRUITING

Yeungnam University Hospital

Daegu, South Korea

RECRUITING

National Cancer Center

Goyang-si, 10408, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, South Korea

WITHDRAWN

Jeonbuk National University Hospital

Jeonju, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam, South Korea

RECRUITING

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 6591, South Korea

WITHDRAWN

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, South Korea

RECRUITING

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

NOT YET RECRUITING

Ajou University Hospital

Suwon, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, South Korea

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia

Interventions

quizartinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Contact for Trial Information

CONTACT

908-992-6400; CTRinfo_us@daiichisankyo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: July 18, 2025
• Primary Completion (Estimated): June 6, 2028
• Study Completion (Estimated): July 14, 2032
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

KR (15); AU (7); US (9); BR (8); CN (19)