About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Busulfan Injection
Druginjections doses will be personalized by PK at days -7 and -4
Treatment groups
Trial outcomes
Primary outcomes
non-relapse mortality evaluation
non-relapse mortality evaluation
Secondary outcomes
incidence of grade 3 or 4 toxicities
To evaluate toxicities linked to sequential bususlfan administration
graft taking after sequential busulfan conditioning
incidence of hematological reconstituation
incidence of transfusion needs for red blood cells
number of transfusions after graft
incidence of transfusion needs for red blood cells
number of transfusions after graft
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: