Clinical trial · no report yet · Phase 2/Phase 3
BIG-1
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
- NCT02416388 ↗
- Recruiting
- University Hospital, Angers
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| X threads | 2 | |
| Bluesky threads | 1 |
The trial
ClinicalTrials.gov- Official title
- Phase II/III Randomized Study to Improve Overall Survival 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 Mycophenolate Mofetil Prophylaxis of Graft Versus Host Disease in Allografted Patients in First CR : a Backbone InterGroup-1 Trial
- Phase
- Phase 2/Phase 3
- Status
- Recruiting
- Conditions
- Acute Myeloid Leukemia (AML)
- Interventions
- Idarubicin; Daunorubicin; HD Cytarabine; Cyclosporine; Methotrexate; Mycophenolic acid (MPA); vosaroxin; ID cytarabine; Dexamethasone; Venetoclax
- Arms
- R1-IDA · Experimental
- R1-DAUNO · Active comparator
- R2-HDAC · Active comparator
- R2-IDAC · Experimental
- R3-MAC-MTX · Active comparator
- R3-MAC-MPA · Experimental
- R3-RIC-CICLO · Active comparator
- R3-RIC-MPA · Experimental
- R4-VOS-IDAC · Experimental
- R4-IDAC (without VOS) · Active comparator
- R4-DEX-HDAC · Experimental
- R4-HDAC (without DEX) · Active comparator
- R4-VEN-IDAC · Experimental
- R4-IDAC (without VEN) · Active comparator
- Enrollment
- 3,100 (estimated)
- Primary outcomes
- Overall survival
- Cumulative incidence (CI) of acute Graft versus Host Disease (GvHD) of grade II to IV
- Disease free survival
- Sponsor
- University Hospital, Angers
- Start
- Jan 2015
- Primary completion
- Jul 30, 2025
- Results posted
- No
- Registry record
- NCT02416388 · updated Jul 17, 2026
Publications
linked from the registry- Duployez N, Joudinaud R, Boudry A, Hunault M, Fenwarth L, Tavernier E, Pautas C, Bertoli S, Tavitian S, Raffoux E, Hospital MA, Marchand T, Heiblig M, Chantepie S, Carre M, Peterlin P, Gallego-Hernanz MP, Guieze R, Simand C, Turlure P, Huynh A, Lemasle E, Gabellier L, Lambert J, Suarez F, Chraibi S, Sanhes L, Celli-Lebras K, Mineur A, Gardin C, Ifrah N, Vey N, Peffault De Latour R, Rigolot L, Luquet I, Penther D, Itzykson R, Delabesse E, Hamel JF, De Botton S, Pigneux A, Dombret H, Recher C, Preudhomme C, Dumas PY. Prognostic impact of FLT3-ITD microclones in young adults with acute myeloid leukemia treated with intensive chemotherapy. Blood. 2026 Jul 30;148(5):598-609. doi: 10.1182/blood.2025032829. PubMed 42166362
- Hunault M, Pautas C, Bertoli S, Dumas PY, Raffoux E, Hospital MA, Marchand T, Heiblig M, Chantepie S, Carre M, Peterlin P, Gallego-Hernanz MP, Lemasle E, Guieze R, Simand C, Turlure P, Huynh A, Leguay T, Devillier R, Quoc SN, Duployez N, Luquet I, Penther D, Celli-Lebras K, Mineur A, Raus N, Gardin C, Socie G, Cahn JY, Ifrah N, Vey N, de Latour RP, Delabesse E, Preudhomme C, Hamel JF, Pigneux A, Recher C, Dombret H. Intermediate-Dose Cytarabine as Postinduction AML Therapy. NEJM Evid. 2025 Jul;4(7):EVIDoa2400326. doi: 10.1056/EVIDoa2400326. Epub 2025 Jun 24. PubMed 40552969