臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 18, 2024
Last modified on	Oct. 18, 2024
Trial ID	jRCT2061240069

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 (QuANTUM-Wild)
Public Title	Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

Contact for Scientific Queries	Name	Inoguchi Akihiro
	Affiliation	Daiichi Sankyo Co., Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Telephone	+81-3-6225-1111
	E-mail	dsclinicaltrial@daiichisankyo.co.jp
Contact for Public Queries	Name	Contact for Clinical Trial Information
	Affiliation	Daiichi Sankyo Co., Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Telephone	+81-3-6225-1111
	E-mail	dsclinicaltrial@daiichisankyo.co.jp

Recruitment status	Pending

Anticipated date of first enrollment		Nov. 01, 2024
Actual date of first enrollment
Target sample size		700
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- 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
	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.
	Age Minimum	18age old over
	Age Maximum	70age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Acute Myeloid Leukemia
Intervention(s)		Experimental: Arm A: Quizartinib + Chemotherapy (Cytarabine, Daunorubicin or Idarubicin) 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 (Cytarabine, Daunorubicin or Idarubicin) 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 (Cytarabine, Daunorubicin or Idarubicin) 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)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Efficacy: Overall survival (OS)
Secondary Outcome(s)		Efficacy: Event-free survival (EFS), Duration of complete response (DoCR), Relapse-free survival (RFS), Complete remission rate (CR), CR rate with minimal or measurable residual disease (MRD) Safety and tolerability: Treatment-emergent adverse events (TEAE)

Primary Sponsor	Daiichi Sankyo Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Chugoku Central Hospital Institutional Review Board
Address	148-13, Oaza Kamiiwanari Miyuki-cho Fukuyama-shi, Hiroshima, Hiroshima
Telephone	+81-84-970-2121
E-Mail
Approval Status	Approval
Date of approval	Sept. 18, 2024

Plan to share IPD	Yes
Plan description	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 Information: - Study Protocol - Statistical Analysis Plan (SAP) - Informed Consent Form (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. URL: https://vivli.org/ourmember/daiichi-sankyo/

Plan to share IPD

Yes

Plan description

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 Information: - Study Protocol - Statistical Analysis Plan (SAP) - Informed Consent Form (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. URL: https://vivli.org/ourmember/daiichi-sankyo/

Secondary ID(s)	NCT06578247
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	Australia/Austria/Belgium/Brazil/Bulgaria/Canada/China/Croatia/Czech/Denmark/France/Germany/Hong Kong/Hungary/Israel/Italy/Korea/Norway/Poland/Portugal/Romania/Serbia/Singapore/Spain/Sweden/Switzerland/Taiwan/Ukraine/United Kingdom/United States