A Randomized, Multi-Center Phase III Trial comparing two conditioning regimens (CloFluBu and BuCyMel) in children with Acute Myeloid Leukemia undergoing allogeneic stem cell transplantation.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505512-37-00

Enrollment

105

Registered

2023-11-07

Start date

2022-06-07

Completion date

Unknown

Last updated

2025-11-06

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

Conditions

Acute Myeoloid Leukemia

Brief summary

The primary endpoint is the 2-year acute grade III to IV-free, chronic non-limited GVHD-free, relapse free survival, GvHD III-IV, chronic non-limited GvHD, relapse, death) or last follow-up

Detailed description

- Disease free Survival (DFS, - Overall Survival (OS), - Cumulative incidence of relapse (CIR, - Transplant-related Mortality (TRM), - Hematologic Recovery, - Graft Failure (GF), - Immune Reconstitution, - Chronic GVHD, -Infections, - Toxicity, - Transplant-associated hormonal and gonadal late effect, - Nutritional status

Interventions

DRUGGrafalon 20 mg/ml concentrate for solution for infusion

DRUGSendoxan pulver till injektionsvätska

DRUGlösning

DRUGBusulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion

DRUGAlkeran 50 mg pulver och vätska till injektionsvätska

DRUGThymoglobuline 25 mg powder for solution for infusion

DRUGFludarabin Actavis 25 mg/ml koncentrat till injektions-/infusionsvätska

DRUGEvoltra 1 mg/ml concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the 2-year acute grade III to IV-free, chronic non-limited GVHD-free, relapse free survival, GvHD III-IV, chronic non-limited GvHD, relapse, death) or last follow-up	—

Secondary

Measure	Time frame
- Disease free Survival (DFS, - Overall Survival (OS), - Cumulative incidence of relapse (CIR, - Transplant-related Mortality (TRM), - Hematologic Recovery, - Graft Failure (GF), - Immune Reconstitution, - Chronic GVHD, -Infections, - Toxicity, - Transplant-associated hormonal and gonadal late effect, - Nutritional status	—

Countries

Belgium, Denmark, Finland, Netherlands, Norway, Sweden

Outcome results

None listed

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