Phase 3 trial aimed at improving the overall survival of AML in adults aged 18 to 60 by comparing high-dose idarubicin with daunorubicin at induction, high-dose and intermediate-dose cytarabine at consolidation and mycophenolic acid as standard prophylaxis in the prevention of graft versus host disease in allograft patients in first complete remission after reduced conditioning: Backbone Inter-Group-1 (BIG-1) trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516873-57-00

Acronym

BIG-1

Enrollment

3100

Registered

2024-10-24

Start date

2026-01-13

Completion date

Unknown

Last updated

2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia in adults aged 18 to 60

Brief summary

For R1 and R2 randomizations: The primary endpoint will be a comparison of overall survival (OS) at 3 years according to the treatment considered (idarubicin vs. daunorubicin for randomization 1, and high-dose cytarabine 3.0 g/m2 vs. intermediate-dose cytarabine 1.5 g/m2 for randomization 2). For R3 randomization: The primary endpoint will be the cumulative incidence of grade II to IV acute GvHD at D100, compared according to the GvHD prophylaxis regimen considered (standard regimen or mycopheno

Interventions

DRUGVenetoclax

DRUGCYTARABINE

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
For R1 and R2 randomizations: The primary endpoint will be a comparison of overall survival (OS) at 3 years according to the treatment considered (idarubicin vs. daunorubicin for randomization 1, and high-dose cytarabine 3.0 g/m2 vs. intermediate-dose cytarabine 1.5 g/m2 for randomization 2). For R3 randomization: The primary endpoint will be the cumulative incidence of grade II to IV acute GvHD at D100, compared according to the GvHD prophylaxis regimen considered (standard regimen or mycopheno	—

Measure

Time frame

—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026