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Not yet recruiting NCT04451200

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

Phase II Interventional Acute Leukemia Mielodysplasic Syndrome Myeloproliferative Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Busulfan Injection.
Who it may be relevant to
Registry conditions: Acute Leukemia, Mielodysplasic Syndrome, Myeloproliferative Neoplasm. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Sequential and Personalized Pharmacokinetic-guided Busulfan Administration in the Frame of the Conditiong Regimen for Allogeneic Haematopoietic Stem Cell Transplantation in Patients With Malignant Hemopathies Ineligible for the Standard Myeloablative Conditioning

Overview

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.

Interventions

  • Drug Busulfan Injection
    injections doses will be personalized by PK at days -7 and -4

Primary outcome measures

  • non-relapse mortality evaluation [Time frame: 100 days post graft]
Secondary outcome measures (12)
  • incidence of grade 3 or 4 toxicities [Time frame: 1 month]
  • graft taking after sequential busulfan conditioning [Time frame: day 30 and day 100 post graft]
  • incidence of transfusion needs for red blood cells [Time frame: day 30 post graft]
  • incidence of transfusion needs for red blood cells [Time frame: day 60 post graft]
  • incidence in graft taking after sequential busulfan conditioning [Time frame: day 100 post graft]
  • anti-tumoral efficacy of sequential busulfan conditioning: incidence of acute GVH [Time frame: 1 year]
  • anti-tumoral efficacy of sequential busulfan conditioning: incidence of acute GVH [Time frame: 5 years]
  • the anti-tumoral efficacy of sequential busulfan conditioning: incidence of chronic GVH [Time frame: 1 and 5 years]
  • the anti-tumoral efficacy of sequential busulfan conditioning: incidence of chronic GVH [Time frame: 1 year]
  • anti-tumoral efficacy of sequential busulfan conditioning: progression-free survival [Time frame: 5 years]
  • anti-tumoral efficacy of sequential busulfan conditioning: progression-free survival [Time frame: 1 year]
  • anti-tumoral efficacy of sequential busulfan conditioning: progression-free survival [Time frame: 5 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT04451200 · BUSEQ-IPC 2020-006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗