Actively Recruiting
Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission
Led by Daiichi Sankyo · Updated on 2025-12-04
130
Participants Needed
58
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older on the day of signing consent
- Newly diagnosed with primary AML or AML secondary to myelodysplastic syndrome or myeloproliferative neoplasm
- Confirmed FLT3-ITD positive mutation from initial diagnosis
- In first complete remission with less than 5% blasts in bone marrow and no leukemia in peripheral blood
- Absolute neutrophil count above 1,000 x 10^9/L and platelets above 100 x 10^9/L
- Received at least one cycle but no more than two cycles of induction therapy
- Received no more than four cycles of consolidation therapy
- Allowed prior FLT3 inhibitor use with a 14-day washout before enrollment
- Able to start maintenance therapy within 60 days after last consolidation cycle
- Eastern Cooperative Oncology Group performance status of 0 to 2
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL) or BCR-ABL positive leukemia
- AML caused by prior chemotherapy or radiotherapy for other cancers
- Prior AML treatments beyond allowed induction, consolidation, leukapheresis, hydroxyurea, cranial radiotherapy, intrathecal chemotherapy, or growth factors
- Received allogeneic hematopoietic stem cell transplantation for AML
- Treatment with strong or moderate CYP3A inducers within two weeks before randomization
- Significant or uncontrolled cardiovascular disease including:
- QTcF interval over 450 ms
- Congenital long QT syndrome or family history
- History of serious ventricular arrhythmias
- Bradycardia below 50 bpm without pacemaker
- History of second- or third-degree heart block without pacemaker
- Heart attack within 6 months
- Uncontrolled angina within 6 months
- Severe heart failure (NYHA Class 3 or 4)
- Left ventricular ejection fraction 45% or less
- Uncontrolled high blood pressure
- Complete left or right bundle branch block
- Severe aortic stenosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 58 locations
1
John Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
2
Umass Memorial Health Care Systems
Worcester, Massachusetts, United States, 01655
Not Yet Recruiting
3
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Withdrawn
4
Weill Cornell
New York, New York, United States, 10021-9800
Not Yet Recruiting
5
Westchester Medical College
Valhalla, New York, United States, 10595
Withdrawn
6
Clinical Research Allicance
Westbury, New York, United States, 11590
Actively Recruiting
7
Spoknwrd Clinical Trials Inc.
Easton, Pennsylvania, United States, 18045
Not Yet Recruiting
8
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Not Yet Recruiting
9
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
10
Royal Adelaide Hospital
Adelaide, Australia
Not Yet Recruiting
11
Austin Health
Australia, Australia
Not Yet Recruiting
12
St. Vincent's Hospital Melbourne
Darlinghurst, Australia
Not Yet Recruiting
13
The Alfred Hospital
Melbourne, Australia
Not Yet Recruiting
14
Royal Perth Hospital
Perth, Australia
Not Yet Recruiting
15
Gold Coast University Hospital
Southport, Australia
Not Yet Recruiting
16
Westmead Hospital
Sydney, Australia
Not Yet Recruiting
17
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer
Curitiba, Brazil
Actively Recruiting
18
Cetus Hospital Dia Oncologia
Minas Gerai, Brazil
Actively Recruiting
19
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
Actively Recruiting
20
Irmandade da Santa Casa de Misericórdia de Porto Alegre Centro Multidisciplinar de Pesquisa
Porto Alegre, Brazil
Actively Recruiting
21
INCA - Instituto Nacional de Câncer
Rio de Janeiro, Brazil
Actively Recruiting
22
"Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto CIP - Centro Integrado de Pesquisa"
San Jose Rio Preto, Brazil
Actively Recruiting
23
Hospital Santa Marcelina
São Paulo, Brazil
Actively Recruiting
24
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo, Brazil
Actively Recruiting
25
Peking Union Medical College Hospital
Beijing, China
Not Yet Recruiting
26
Peking University Third Hospital
Beijing, China
Actively Recruiting
27
The First Hospital of Jilin University
Changchun, China
Actively Recruiting
28
Guangdong Provincial People's Hospital
Guangzhou, China
Actively Recruiting
29
Nanfang Hospital of Southern Medical University
Guangzhou, China
Actively Recruiting
30
Sun Yat-sen University Cancer center
Guangzhou, China
Not Yet Recruiting
31
The First Affiliated Hosptial of Zhejiang University School of Medicine
Hangzhou, China
Not Yet Recruiting
32
The First Affiliated Hospital of Nanchang University
Nanchang, China
Not Yet Recruiting
33
Zhong Da Hospital, Southeast University
Nanjing, China
Not Yet Recruiting
34
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
Actively Recruiting
35
The Affiliated Hospital of Qingdao University
Qingdao, China
Not Yet Recruiting
36
Huashan Hospital, Fudan University
Shanghai, China
Not Yet Recruiting
37
The First Affiliated Hospital of Soochow University
Suzhou, China
Not Yet Recruiting
38
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, China
Not Yet Recruiting
39
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Not Yet Recruiting
40
The First Affiliated Hospital of Jiaotong University
Xi'an, China
Not Yet Recruiting
41
The First Affiliated Hospital of Xiamen University
Xiamen, China
Not Yet Recruiting
42
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, China
Not Yet Recruiting
43
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Not Yet Recruiting
44
Inje University Haeundae Paik Hospital
Busan, South Korea
Actively Recruiting
45
Pusan National University Hospital
Busan, South Korea
Actively Recruiting
46
Kyungpook National University Hospital
Daegu, South Korea
Not Yet Recruiting
47
Yeungnam University Hospital
Daegu, South Korea
Actively Recruiting
48
National Cancer Center
Goyang-si, South Korea, 10408
Not Yet Recruiting
49
Gachon University Gil Medical Center
Incheon, South Korea
Withdrawn
50
Jeonbuk National University Hospital
Jeonju, South Korea
Actively Recruiting
51
Seoul National University Bundang Hospital
Seongnam, South Korea
Actively Recruiting
52
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 6591
Not Yet Recruiting
53
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
54
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
55
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Actively Recruiting
56
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Not Yet Recruiting
57
Ajou University Hospital
Suwon, South Korea
Actively Recruiting
58
Ulsan University Hospital
Ulsan, South Korea
Actively Recruiting
Research Team
C
Contact for Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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