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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06824168




Registration number
NCT06824168
Ethics application status
Date submitted
7/02/2025
Date registered
13/02/2025
Date last updated
4/09/2025

Titles & IDs
Public title
Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission
Scientific title
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
Secondary ID [1] 0 0
AC220-167
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Quizartinib High Dose
Treatment: Drugs - Quizartinib Low Dose

Experimental: Arm 1 - Participants will receive higher dose of quizartinib

Experimental: Arm 2 - Participants will receive lower dose of quizartinib


Treatment: Drugs: Quizartinib High Dose
Participants in Arm 1 will receive oral daily higher dose of quizartinib,

Treatment: Drugs: Quizartinib Low Dose
Participants in Arm 2 will receive oral daily lower dose of quizartinib
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Serious Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
From date of first dose to 30 days after last dose, up to 87 months
Secondary outcome [1] 0 0
TEAEs
Timepoint [1] 0 0
From date of first dose to 30 days after last dose, up to 87 months
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From date of randomization to death from any cause, up to 87 months
Secondary outcome [3] 0 0
Relapse-free Survival (RFS)
Timepoint [3] 0 0
From date of randomization to documented relapse or death from any cause, whichever comes first, up to 87 months

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/07/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/07/2032
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Austin Health - Australia
Recruitment hospital [3] 0 0
St. Vincent's Hospital Melbourne - Darlinghurst
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [6] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [7] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Australia
Recruitment postcode(s) [3] 0 0
- Darlinghurst
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment postcode(s) [6] 0 0
- Southport
Recruitment postcode(s) [7] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Brazil
State/province [6] 0 0
Curitiba
Country [7] 0 0
Brazil
State/province [7] 0 0
Minas Gerai
Country [8] 0 0
Brazil
State/province [8] 0 0
Porto Alegre
Country [9] 0 0
Brazil
State/province [9] 0 0
Rio de Janeiro
Country [10] 0 0
Brazil
State/province [10] 0 0
San Jose Rio Preto
Country [11] 0 0
Brazil
State/province [11] 0 0
São Paulo
Country [12] 0 0
China
State/province [12] 0 0
Beijing
Country [13] 0 0
China
State/province [13] 0 0
Changchun
Country [14] 0 0
China
State/province [14] 0 0
Guangzhou
Country [15] 0 0
China
State/province [15] 0 0
Hangzhou
Country [16] 0 0
China
State/province [16] 0 0
Nanchang
Country [17] 0 0
China
State/province [17] 0 0
Nanjing
Country [18] 0 0
China
State/province [18] 0 0
Nanning
Country [19] 0 0
China
State/province [19] 0 0
Qingdao
Country [20] 0 0
China
State/province [20] 0 0
Shanghai
Country [21] 0 0
China
State/province [21] 0 0
Suzhou
Country [22] 0 0
China
State/province [22] 0 0
Wenzhou
Country [23] 0 0
China
State/province [23] 0 0
Xi'an
Country [24] 0 0
China
State/province [24] 0 0
Xiamen
Country [25] 0 0
China
State/province [25] 0 0
Xuzhou
Country [26] 0 0
China
State/province [26] 0 0
Zhengzhou
Country [27] 0 0
South Korea
State/province [27] 0 0
Busan
Country [28] 0 0
South Korea
State/province [28] 0 0
Daegu
Country [29] 0 0
South Korea
State/province [29] 0 0
Goyang-si
Country [30] 0 0
South Korea
State/province [30] 0 0
Incheon
Country [31] 0 0
South Korea
State/province [31] 0 0
Jeonju
Country [32] 0 0
South Korea
State/province [32] 0 0
Seongnam
Country [33] 0 0
South Korea
State/province [33] 0 0
Seoul
Country [34] 0 0
South Korea
State/province [34] 0 0
Suwon
Country [35] 0 0
South Korea
State/province [35] 0 0
Ulsan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Daiichi Sankyo
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Contact for Trial Information
Address 0 0
Country 0 0
Phone 0 0
908-992-6400
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/daiichi-sankyo/


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06824168