Trials / Not Yet Recruiting
Not Yet RecruitingNCT04451200
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
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- Sponsor
- Institut Paoli-Calmettes · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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 possibility of significanty reducing this toxicity by customizing the doses of busulfan to individual PK parameters.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Busulfan Injection | injections doses will be personalized by PK at days -7 and -4 |
Timeline
- Start date
- 2020-11-01
- Primary completion
- 2023-11-01
- Completion
- 2028-12-01
- First posted
- 2020-06-30
- Last updated
- 2020-11-17
Source: ClinicalTrials.gov record NCT04451200. Inclusion in this directory is not an endorsement.