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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstitut Paoli-Calmettes

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Busulfan Injection

    Drug

    injections doses will be personalized by PK at days -7 and -4

Treatment groups

82 Participants
are divided into 1 treatment group
Group A: busulfan treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

non-relapse mortality evaluation

non-relapse mortality evaluation

Time frame
100 days post graft

Secondary outcomes

1

incidence of grade 3 or 4 toxicities

To evaluate toxicities linked to sequential bususlfan administration

Time frame
1 month
2

graft taking after sequential busulfan conditioning

incidence of hematological reconstituation

Time frame
day 30 and day 100 post graft
3

incidence of transfusion needs for red blood cells

number of transfusions after graft

Time frame
day 30 post graft
4

incidence of transfusion needs for red blood cells

number of transfusions after graft

Time frame
day 60 post graft

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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