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NCT04451200Not yet recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 17 Nov 2020 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
82 (estimated)
First submitted
3 Jun 2020
Start date
Nov 2020
Primary completion date
Nov 2023
Lead sponsor
Institut Paoli-Calmettes
NCT number
NCT04451200

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 82
  • From Nov 2020 to the primary completion date, Nov 2023
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindications to performing an allogeneic transplant
  • Previous allograft

Other

  • 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
  • Placental blood allograft

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.