Sequential and Personalized PK-guided Busulfan Administration in the Frame of the Conditiong Regimen for Allo-HSCT in Patients With Malignant Hemopathies Ineligible for the Standard Myeloablative Conditioning

• Status: Not yet recruiting
• Trial end date: 2028-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Because the anti-leukemic activity of busulfan, this dug is largely used in graft conditioning but in elderly and/or cormobid patienth an excess of toxicity is observed. This study focus on the possibility of significanty reducing this toxicity by customizing the doses of busulfan to individual PK parameters.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Paoli-Calmettes
• Treatments: Busulfan

Criteria

Inclusion Criteria:

• Adult patient up to 65 years old

• Acute leukemia, myelodysplastic syndrome or myeloproliferative neoplasia eligible for an allogeneic transplant

• Chemosensitive disease, in complete or partial or stable remission

• Allograft from an identical HLA related donor, Haplo-identical or unrelated (HLA compatibility from 8/10 to 10/10 according to HLA-A, -B, -C, -DR, -DQ allelics)

• Signed consent to participate

-. Affiliation to a social security regimen or beneficiary of this regimen

• Patient not eligible for standard myeloablative conditioning due to age> = 45 years and / or the presence of an HCT-CI comorbidity score> = 3

Exclusion Criteria:

• Pregnant woman, without effective contraception or breastfeeding

• Person in emergency situation, patient deprived of liberty or placed under the authority of a tutor,

• Impossibility of undergoing medical follow-up of the trial for geographic, social or psychological reasons

• Contraindications to performing an allogeneic transplant

• Previous allograft

• Placental blood allograft