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Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

Study acronym: QuANTUM-WILD
StatusActive, Not Recruiting
PhasePhase 3
Started2024-11-19
View on ClinicalTrials.gov ↗

Amendment history

2026-06-30
Study Status, Contacts/Locations v26
Trial status changed: Recruiting → Active, Not Recruiting
Trial sites reduced: 288 → 284 locations
2026-04-28
Study Status, Contacts/Locations v25
Trial sites reduced: 292 → 288 locations
2026-03-27
Study Status, Contacts/Locations v24
Study sitesdetails revised at 4 of 292 sites
2026-02-24
Study Status, Contacts/Locations v23
Study sitesdetails revised at 3 of 292 sites
2026-01-09
Study Status, Contacts/Locations v22
Study sites291→292
Show 21 earlier versions
2026-01-06
Study Status, Contacts/Locations v21
Study sites283→291
2025-12-04
Study Status, Contacts/Locations v20
Study sites282→283
2025-11-21
Study Status, Contacts/Locations v19
Study sites280→282
2025-11-10
Study Status, Contacts/Locations v18
Study sites276→280
2025-10-22
Study Status, Contacts/Locations v17
Study sites274→276
2025-10-14
Study Identification, Study Status, Outcome Measures, Eligibility, Contacts/Locations v16
Eligibility criteria+64 characters
[...] ommittee (EC)- or Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before performance of any trial-specific procedures or test [...] s or the minimum legal adult age (whichever is greater) and ≤70 years (at Screening). Newly diagnosed, morphologically do [...] ime the participant signs their ICF) of 0-2. Participant is receivinga candidate for standard "7+3" induction chemotherapy regimen as specified in the protocol per investigator assessment Key Exclusion Criteria: Diagnosis of acute promyelocytic le [...] nosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms or a [...] [...]
Secondary endpointsdetails revised at 5 of 6 entries
Study sites274 entries, revised
Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Că'NcerCăncer Hc-Ufg - Hospital Das Clă NicasClănicas Da Universidade Federal de Goiă SGoiăs Hospital de Clă NicasClănicas de Passo Fundo Hospital de Clă NicasClănicas de Porto Alegre Umhat  SvÂsv. Ivan Rilskiâ, Ead The First Affiliated Hospital of Xiâ AnXiâan Jiaotong University Chu Angers - Hă"PitalHăpital Hă"TelHătel Dieu Chu de Bordeaux - Hă"PitalHăpital Haut-Lă Vă QueLăvăque Institut de Cancă RologieCancărologie de Strasbourg Europe - Icans Universită"TsklinikumUniversitătsklinikum Leipzig Klinik FăFăr R Hă"MatologieHămatologie Int [...] [...]
2025-10-02
Study Status, Contacts/Locations v15
Study sites273→274
2025-09-22
Study Status, Contacts/Locations v14
Study sites270→273
2025-09-08
Study Status, Contacts/Locations v13
Study sites269→270
2025-08-25
Study Status, Contacts/Locations v12
Study sites268→269
2025-08-06
Study Status, Contacts/Locations v11
Study sites267→268
2025-07-30
Study Status, Contacts/Locations v10
Study sites265→267
2025-07-16
Study Status, Contacts/Locations v9
Study sites265 entries, revised
Cepon - Centro deDe Pesquisas Oncolă"GicasOncolagicas de Santa Catarina HuwcHUWC - UfcUFC - Hospital Universită RioUniversitário Walter Cantă DioCantídio - Universidade Federal Dodo CearăCeará Santa Casa de Miserică"Rdia de Porto Alegre IncaINCA - Instituto Nacional de Că'NcerCancer Hospital Benefică NciaBeneficencia Portuguesa deda Să OSao Paulo Guangdong Provincial People's Hospital Chu de Grenoble - Hă"PitalHospital Albert Michallon Hă"PitalHospital Saint-Louis
2025-06-09
Study Status, Contacts/Locations v8
Study sites258→265
2025-05-02
Study Status, Contacts/Locations v7
Study sites256→258
2025-04-01
Study Status, Contacts/Locations v6
Study sites254→256
2025-02-18
Study Status, Contacts/Locations v5
Study sites253→254
2025-01-15
Study Status, Contacts/Locations v4
Study sites252→253
2024-12-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-10-30→confirmed 2024-11-19
Study sites252 entries, revised
UsfTampa CollegeGeneral of MedicineHospital Lkh - Universită"TsklinikumUniversitătsklinikum Der Pmu Salzburg Chu de Liă GeLiăge Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Că'NcerCăncer Cepon - Centro de Pesquisas Oncolă"GicasOncolăgicas de Santa Catarina Huwc - Ufc - Hospital Universită RioUniversitărio Walter Cantă DioCantădio - Universidade Federal Do Ceară Hc-Ufg - Hospital Das Clă NicasClănicas Da Universidade Federal de Goiă SGoiăs Hospital de Clă NicasClănicas de Passo Fundo Santa Casa de Miserică"RdiaMisericărdia de Porto Alegre Hospital de Clă NicasClănicas de Porto Alegr [...] [...]
2024-10-14
Study Status, Contacts/Locations v2
Study sites0→252
2024-08-29
Study Status, Study Design v1
Re-verified, no change to tracked fields
2024-08-27
Original filing
Daiichi Sankyo
69 trials monitored
See 8 trials at risk
Leukemia
2,553 trials monitored
See 134 trials at risk
This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).
Trial Details
NCT Number NCT06578247
Lead Sponsor Daiichi Sankyo
Conditions Leukemia
Enrollment 700 participants
Start Date 2024-11-19
Primary Completion 2030-06-26 (estimated)
Study Completion 2030-06-26 (estimated)
Updated on ClinicalTrials.gov 2026-07-02