Last updated 20 days ago
Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
700 patients around the world
Available in Brazil
This is a clinical trial to compare the effect of quizartinib versus placebo
(administered with standard induction and consolidation chemotherapy, then administered
as maintenance therapy for up to 36 cycles) on the primary endpoint of overall survival
(OS) in adult patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal
tandem duplication (ITD) negative acute myeloid leukemia (AML). Participants will be
tested for FLT3-ITD mutation status in a central laboratory using a validated assay.
Daiichi Sankyo
16Research sites
700Patients around the world
This study is for people with
Leukemia
Acute myeloid leukemia
Requirements for the patient
To 70 Years
All Gender
Medical requirements
- 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.
- 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:Leukapheresis.Treatment for hyperleukocytosis with hydroxyurea.Cranial radiotherapy for central nervous system (CNS) leukostasis.Prophylactic intrathecal chemotherapy.Growth factor/cytokine support.
Sites
Hospital de Clínicas de Porto Alegre
Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP
Hospital de Clínicas - Universidade Estadual de Campinas - UNICAMP
Hospital Erasto Gaertner
Centro Pesquisas Oncologicas - CEPON
Hospital Universitário Walter Cantídio - Universidade Federal do Ceará - Fortaleza, Ceara
Hospital das Clínicas da Universidade Federal de Goiás - UFG
Hospital Amaral Carvalho
Hospital de Clínicas de Passo Fundo
Irmandade da Santa Casa de Misericórdia de Porto Alegre
StudyQuANTUM-WILD
SponsorDaiichi Sankyo
Study typeInterventional
Conditions
Acute myeloid leukemia
Requirements
To 70 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06578247
