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NCT Number: 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

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.

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Key information

Conditions

Acute Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Mielodysplasic Syndrome Myeloproliferative Disorders Myeloproliferative Neoplasm

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Busulfan Injection

Drug

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

Primary outcomes

  1. non-relapse mortality evaluation

    Time frame: 100 days post graft

    non-relapse mortality evaluation

Secondary outcomes

  1. incidence of grade 3 or 4 toxicities

    Time frame: 1 month

    To evaluate toxicities linked to sequential bususlfan administration

  2. graft taking after sequential busulfan conditioning

    Time frame: day 30 and day 100 post graft

    incidence of hematological reconstituation

  3. incidence of transfusion needs for red blood cells

    Time frame: day 30 post graft

    number of transfusions after graft

  4. incidence of transfusion needs for red blood cells

    Time frame: day 60 post graft

    number of transfusions after graft

  5. incidence in graft taking after sequential busulfan conditioning

    Time frame: day 100 post graft

    Lymphocyte chimerism

  6. anti-tumoral efficacy of sequential busulfan conditioning: incidence of acute GVH

    Time frame: 1 year

    incidence of acute GVH

  7. anti-tumoral efficacy of sequential busulfan conditioning: incidence of acute GVH

    Time frame: 5 years

    incidence of acute GVH

  8. the anti-tumoral efficacy of sequential busulfan conditioning: incidence of chronic GVH

    Time frame: 1 and 5 years

    incidence of chronic GVH

  9. the anti-tumoral efficacy of sequential busulfan conditioning: incidence of chronic GVH

    Time frame: 1 year

    incidence of chronic GVH

  10. anti-tumoral efficacy of sequential busulfan conditioning: progression-free survival

    Time frame: 5 years

    progression-free survival

  11. anti-tumoral efficacy of sequential busulfan conditioning: progression-free survival

    Time frame: 1 year

    overall survival

  12. anti-tumoral efficacy of sequential busulfan conditioning: progression-free survival

    Time frame: 5 years

    overall survival

  13. anti-tumoral efficacy of sequential busulfan conditioning: Incidence of relapse

    Time frame: 1 year

    Incidence of relapse

  14. Differences between the theoretical target AUC and the measured a posteriori

    Time frame: 1 month

    To study the pharmacokinetics of the sequential administration of busulfan

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique Genre, MD

CONTACT

[email protected]

+33491223778

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study 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

Acronym: BUSEQ

Important dates

Study start
2020
Primary completion
2023
Study completion
2028
First posted
Jun 30, 2020
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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