Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Mielodysplasic Syndrome | — | UNRESOLVED | — |
| Myeloproliferative Neoplasm | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan Injection | Drug | Busulfan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- busulfan treatment
- description
- Personalized BU administration
- interventionNames
- Drug: Busulfan Injection
Primary outcomes (1)
- measure
- non-relapse mortality evaluation
- timeFrame
- 100 days post graft
- description
- non-relapse mortality evaluation
Secondary outcomes (14)
- measure
- incidence of grade 3 or 4 toxicities
- timeFrame
- 1 month
- description
- To evaluate toxicities linked to sequential bususlfan administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available