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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06578247




Registration number
NCT06578247
Ethics application status
Date submitted
14/08/2024
Date registered
29/08/2024

Titles & IDs
Public title
Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
Scientific title
Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial Of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy and Administered as Maintenance Therapy in Adult Patients With Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia
Secondary ID [1] 0 0
2023-507936-20-00
Secondary ID [2] 0 0
AC220-168
Universal Trial Number (UTN)
Trial acronym
QuANTUM-WILD
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Quizartinib
Treatment: Drugs - Placebo
Treatment: Drugs - Chemotherapy

Experimental: Arm A: Quizartinib + Chemotherapy - Participants will receive quizartinib at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive quizartinib at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)

Placebo comparator: Arm B: Placebo + Chemotherapy - Participants will receive placebo at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive placebo at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)

Experimental: Arm C: Quizartinib + Chemotherapy then Placebo Maintenance - Participants will receive quizartinib at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive placebo at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)


Treatment: Drugs: Quizartinib
Participants will receive quizartinib at 60 mg/day orally once daily

Treatment: Drugs: Placebo
Participants will receive placebo at 60 mg/day orally once daily

Treatment: Drugs: Chemotherapy
Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (Arm A vs Arm B)
Timepoint [1] 0 0
Date of first patient randomized to the target number of deaths reached, up to approximately 42 months
Secondary outcome [1] 0 0
Event-free survival (Arm A vs. Arm B)
Timepoint [1] 0 0
Date of randomization up to approximately 42 months
Secondary outcome [2] 0 0
Duration of complete response (Arm A vs. Arm B)
Timepoint [2] 0 0
Date of randomization up to approximately 42 months
Secondary outcome [3] 0 0
Relapse-free survival (Arm A vs. Arm B)
Timepoint [3] 0 0
Date of randomization up to approximately 42 months
Secondary outcome [4] 0 0
Complete remission rate (Arm A vs. Arm B)
Timepoint [4] 0 0
At end of Induction Phase, up to approximately 120 days
Secondary outcome [5] 0 0
Complete remission rate with minimal or measurable residual disease (Arm A vs. Arm B)
Timepoint [5] 0 0
At end of Induction Phase (Cycle 1 or Cycles 1 and 2) and at the end of 2 cycles (2 cycles of induction or 1 cycle induction and 1 cycle consolidation)(1 Induction cycle is up to 60 days, 1 Consolidation cycle is 28 days), up to approximately 120 days
Secondary outcome [6] 0 0
Number of Participants With Treatment-emergent Adverse Events (Arm A vs. Arm B)
Timepoint [6] 0 0
Date of first dose up to 30 days after last dose, up to approximately 42 months

Eligibility
Key inclusion criteria
Key

* Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before performance of any trial-specific procedures or tests.
* =18 years or the minimum legal adult age (whichever is greater) and 70 years (at Screening).
* Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening)
* Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
* Participant is receiving standard "7+3" induction chemotherapy regimen as specified in the protocol

Key
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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 (ie, 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 or autoimmune/rheumatologic conditions.
* Diagnosis of AML secondary to myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including CMML, aCML, JMML and others.
* Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD [+]) present at =5% VAF (or =0.05 SR) based on a validated FLT3 mutation assay.
* Prior treatment for AML, except for the following allowances:

1. Leukapheresis;
2. Treatment for hyperleukocytosis with hydroxyurea;
3. Cranial radiotherapy for central nervous system (CNS) leukostasis;
4. Prophylactic intrathecal chemotherapy;
5. Growth factor/cytokine support.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
19/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/06/2030
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
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Royal Adelaide Hospital - Adelaide
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Flinders Medical Centre (Fmc) - Bedford Park
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Box Hill Hospital - Box Hill
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Concord Repatriation General Hospital - Concord
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St Vincent'S Hospital Melbourne - Darlinghurst
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Townsville University Hospital - Douglas
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Liverpool Hospital - Liverpool
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The Alfred Hospital - Melbourne
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Fiona Stanley Hospital - Murdoch
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Sir Charles Gairdner Hospital - Perth
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Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
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3128 - Box Hill
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2139 - Concord
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2010 - Darlinghurst
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4814 - Douglas
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2170 - Liverpool
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3004 - Melbourne
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6150 - Murdoch
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6009 - Perth
Recruitment postcode(s) [11] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Kaohsiung
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Taichung
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Taipei
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Taoyuan County
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Oxford
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Torquay

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
Global Clinical Leader
Address 0 0
Daiichi Sankyo
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daiichi Sankyo Contact for Clinical Trial Information
Address 0 0
Country 0 0
Phone 0 0
908-992-6400
Fax 0 0
Email 0 0
CTRinfo_us@daiichisankyo.com
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/NCT06578247