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

Status: Recruiting
Location: See all (57) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Umass Memorial Health Care Systems
NOT_YET_RECRUITING
Worcester
Maryland
John Hopkins School of Medicine
NOT_YET_RECRUITING
Baltimore
New York
Roswell Park Cancer Institute
WITHDRAWN
Buffalo
Weill Cornell
NOT_YET_RECRUITING
New York
Westchester Medical College
WITHDRAWN
Valhalla
Clinical Research Allicance
RECRUITING
Westbury
Pennsylvania
Spoknwrd Clinical Trials Inc.
NOT_YET_RECRUITING
Easton
Texas
The Methodist Hospital Research Institute
NOT_YET_RECRUITING
Houston
The University of Texas MD Anderson Cancer Center
NOT_YET_RECRUITING
Houston
Other Locations
Australia
Royal Adelaide Hospital
NOT_YET_RECRUITING
Adelaide
Austin Health
NOT_YET_RECRUITING
Australia
St. Vincent's Hospital Melbourne
NOT_YET_RECRUITING
Darlinghurst
The Alfred Hospital
NOT_YET_RECRUITING
Melbourne
Royal Perth Hospital
NOT_YET_RECRUITING
Perth
Gold Coast University Hospital
NOT_YET_RECRUITING
Southport
Westmead Hospital
NOT_YET_RECRUITING
Sydney
Brazil
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer
NOT_YET_RECRUITING
Curitiba
Cetus Hospital Dia Oncologia
NOT_YET_RECRUITING
Minas Gerai
Hospital de Clínicas de Porto Alegre
NOT_YET_RECRUITING
Porto Alegre
Irmandade da Santa Casa de Misericórdia de Porto Alegre Centro Multidisciplinar de Pesquisa
RECRUITING
Porto Alegre
INCA - Instituto Nacional de Câncer
NOT_YET_RECRUITING
Rio De Janeiro
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto CIP - Centro Integrado de Pesquisa
NOT_YET_RECRUITING
San Jose Rio Preto
Hospital Santa Marcelina
NOT_YET_RECRUITING
São Paulo
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
NOT_YET_RECRUITING
São Paulo
China
Peking Union Medical College Hospital
NOT_YET_RECRUITING
Beijing
Peking University Third Hospital
NOT_YET_RECRUITING
Beijing
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Guangdong Provincial People's Hospital
NOT_YET_RECRUITING
Guangzhou
Nanfang Hospital of Southern Medical University
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen University Cancer center
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hosptial of Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Zhong Da Hospital, Southeast University
NOT_YET_RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING
Qingdao
Huashan Hospital, Fudan University
NOT_YET_RECRUITING
Shanghai
The First Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
The First Affiliated Hospital of Jiaotong University
NOT_YET_RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
The Affiliated Hospital of Xuzhou Medical College
NOT_YET_RECRUITING
Xuzhou
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Republic of Korea
Inje University Haeundae Paik Hospital
RECRUITING
Busan
Pusan National University Hospital
RECRUITING
Busan
Kyungpook National University Hospital
NOT_YET_RECRUITING
Daegu
Yeungnam University Hospital
NOT_YET_RECRUITING
Daegu
National Cancer Center
NOT_YET_RECRUITING
Goyang-si
Gachon University Gil Medical Center
RECRUITING
Incheon
Jeonbuk National University Hospital
RECRUITING
Jeonju
Seoul National University Bundang Hospital
RECRUITING
Seongnam
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
NOT_YET_RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
NOT_YET_RECRUITING
Seoul
Ajou University Hospital
NOT_YET_RECRUITING
Suwon
Ulsan University Hospital
RECRUITING
Ulsan
Contact Information
Primary
Contact for Trial Information
CTRinfo_us@daiichisankyo.com
908-992-6400
Time Frame
Start Date: 2025-07-18
Estimated Completion Date: 2032-07-14
Participants
Target number of participants: 130
Treatments
Experimental: Arm 1
Participants will receive higher dose of quizartinib
Experimental: Arm 2
Participants will receive lower dose of quizartinib
Related Therapeutic Areas
Sponsors
Leads: Daiichi Sankyo

This content was sourced from clinicaltrials.gov