AAA-IPC 2011-003 - Prospective and multicentre evaluation of 3 different doses of IV busulfan associated with fludarabine and thymoglobuline in the conditioning of allogeneic stem cell transplantation (SCT) from a matched related or unrelated donor in patients with poor prognosis myeloïd malignancies

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516435-27-00

Enrollment

177

Registered

2024-11-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-05

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

Conditions

High-risk myeloïd malignancies

Brief summary

Time to progression or death

Detailed description

Time to death and cause of death, Time to acute and chronic GVHD according to the NIH classification and relapse, Response to treatment, Hematological recovery defined as the achievement 500 ANC and 50 000 platelets (without transfusion), Full donor chimerism achievement at M1, M2, M3, Occurrence of grade 3-4 adverse events according the CTC AE v4.0 scale within 6 months after conditionning

Interventions

DRUGBusulfan 6 mg/ml concentrate for solution for infusion

DRUGTHYMOGLOBULINE 5 mg/ml

DRUGpoudre pour solution pour perfusion

DRUGFludarabine Accord Healthcare 25 mg/ml solution à diluer pour solution injectable /pour perfusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to progression or death	—

Secondary

Measure	Time frame
Time to death and cause of death, Time to acute and chronic GVHD according to the NIH classification and relapse, Response to treatment, Hematological recovery defined as the achievement 500 ANC and 50 000 platelets (without transfusion), Full donor chimerism achievement at M1, M2, M3, Occurrence of grade 3-4 adverse events according the CTC AE v4.0 scale within 6 months after conditionning	—

Countries

France

Outcome results

None listed

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