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Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR

Study acronym: BIG-1
StatusRecruiting
PhasePhase 2/3
Started2015-01
View on ClinicalTrials.gov ↗

Amendment history

2026-07-16
Study Identification, Study Status v7
Primary completion dateestimated 2025-07→confirmed 2025-07-30
2024-08-06
Study Status, Contacts/Locations v6
Primary completion date2024-06→2025-07
Completion datenot stated→2032-01
Study sites55→56
2020-10-16
Study Status, Arms and Interventions, Eligibility, Contacts/Locations v5
Study arms10→14
InterventionsCyclosporine (Drug), Daunorubicin (Drug), HD Cytarabine (Drug), ID cytarabine (Drug), Idarubicin (Drug), Methotrexate (Drug), Mycophenolic…→Cyclosporine (Drug), Daunorubicin (Drug), Dexamethasone (Drug), HD Cytarabine (Drug), ID cytarabine (Drug), Idarubicin (Drug), Methotrexate…
Eligibility criteria+6,708 characters
[...] syndrome MDS or therapy-related AML) No prior treatment for neither AML, (with the exception of hydroxyurea), nor MDS (with the exception of EPO) ECOG performance status ≤ 3 Absence of severe uncontrolled infection No contraindicationcardiac tocontraindications for the use of anthracyclines : decompensated or uncontrolled heart failur [...] tinine < 150 µmol/l, unless AML-related out of range values WomenGenetic mutation testing of the FLT3 (FLT3-ITD ou FLT3-TKD) gene, performed in local or central laboratory Use of appropriate methods of contraception: for patients treated with Midostaurin: women of [...] [...]
Study sitesdetails revised at 2 of 55 sites
2017-04-12
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v4
PhasePhase 3→Phase 2/3
Study sites52→55
Study arms8→10
InterventionsCyclosporine (Drug), Cytarabine (Drug), Daunorubicin (Drug), Idarubicin (Drug), Methotrexate (Drug), Mycophenolic acid (MPA) (Drug)→Cyclosporine (Drug), Daunorubicin (Drug), HD Cytarabine (Drug), ID cytarabine (Drug), Idarubicin (Drug), Methotrexate (Drug), Mycophenolic…
Eligibility criteria+1,603 characters
[...] tients under tutorship, curatorship or judicial protection) For randomization R4-VOS (post-induction/salvage): Inclusion criteria Patients enrolled in the BIG-1 trial at diagnosis Patients achieving first CR/CRp/CRi after induction or salvage therapy (within 15 days before R4-VOS) Favorable or intermediate risk AML patients, as stratified with BIG-1 prognost [...] For randomization R3 (before AlloHSCT): Inclusion criteria Patients enrolled in the BIG-1 trial at [...]
2016-01-18
Study Status, Contacts/Locations v3
Study sites47→52
Show 2 earlier versions
2015-07-28
Study Status, Contacts/Locations v2
Study sites32→47
2015-04-21
Study Status, Eligibility, Contacts/Locations v1
Study sites24→32
Eligibility criteria+86 characters
Inclusion Criteria (at diagnosis) : Age ≥ 18 years and < 61 years Exclusion Criteria With a newly diagnosed de novo or secondary type AML (post [...] nd ALAT (SGPT) ≤ 2.5 X UNL, creatinine < 150 µmol/l, unless AML-related out of range values related to AML Women of childbearing potential should use appropriate meth [...] hese cytogenetic abnormalities (RUNX1-RUNX1T1, CBFB-MYH11). Patients with secondary AML arising from myeloproliferative disorders previously known according to the 2008 WHO classification Patients with Ph1+ / BCR-ABL+ AML or previous Ph1+/BCR-ABL+ disorder (chronic myelogenous leukemia) Se [...]
2015-04-09
Original filing
This open label, multicenter phase II/III study with multiple randomization phases at differents stages of AML treatment (induction, consolidation and HSCT where applicable) is designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis following allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity (RIC) conditioning, will also be evaluated. With an adaptative design, this clinical trial could test up to 3 novel AML agents of interest.
Trial Details
NCT Number NCT02416388
Lead Sponsor University Hospital, Angers
Conditions Acute Myeloid Leukemia (AML)
Enrollment 3,100 participants
Start Date 2015-01
Primary Completion 2025-07-30 (estimated)
Study Completion 2032-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-17