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

Phase 2

Not yet recruiting

• Conditions: High-risk myeloïd malignancies

• Registration Number: 2024-516435-27-00
• Lead Sponsor: Institut Paoli Calmettes

Brief Summary

To assess the 2-year progression free survival rates in patients with high-risk myeloid ma-lignancies following HSCT using different dose levels of IV Busulfan (BX3 and BX4) com-bined with fludarabine and thymoglobuline as conditioning therapy

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-11-05
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 177

Inclusion Criteria

Patients with poor prognosis myeloid malignancies in particular : myelodysplasic syndrome, AML beyond CR1 regardless of the cytogenetic or molecular abnormalities or CR1 AML after double induction regardless of the cytogenetic or molecular abnormalities or CR1 AML with no criteria for favorable risk according to the ELN classification

Adult patients aged ≥ 50 years up to 65 or < 50 years not eligible for myeloablative conditioning regimen based on TBI or double alkylating agent combinations

Availability of a HLA identical sibling or matched unrelated donor (10/10)

Affiliation to social security

Written Informed Consent

Exclusion Criteria

History of previous Allo-HSCT

HIV positivity

Signs of chronic active hepatitis B and/or C

Evolutive psychiatric disease

Concomitant neoplasic disease

Pregnant or lactating woman or without contraception (for child bearing potential women)

Usual contra-indications for Allo-HSCT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to progression or death		Time to progression or death

Secondary Outcome Measures

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

Trial Locations

Locations (17)

Centre Hospitalier Universitaire De Lille; 🇫🇷 Lille Cedex, France

CHU Saint Eloi; 🇫🇷 Montpellier, France

Centre Hospitalier Universitaire Grenoble Alpes; 🇫🇷 Grenoble Cedex 9, France

Hôpital l'Archet 1; 🇫🇷 Nice, France

CHU d'Estaing; 🇫🇷 Clermont-Ferrand, France

Oncopole Claudius Regaud; 🇫🇷 Toulouse Cedex 9, France

Hospices Civils De Lyon; 🇫🇷 Pierre Benite, France

Centre Hospitalier Universitaire D'Angers; 🇫🇷 Angers, France

Institut de Cancérologie Lucien Neuwirth; 🇫🇷 Saint Priest en Jarez, France

Hopital Saint Antoine; 🇫🇷 Paris Cedex 12, France

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Centre Hospitalier Universitaire De Lille

🇫🇷Lille Cedex, France

Ibrahim YACOUB-AGHA

Site contact

0320445551

Ibrahim.yakoubagha@chru-lille.fr