Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Acute Leukemia
Mielodysplasic Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 possib...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04451200
Start Date
November 1 2020
End Date
December 1 2028
Last Update
November 17 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.