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NOT YET RECRUITING
NCT04451200
PHASE2

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

Sponsor: Institut Paoli-Calmettes

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2020-11

Completion Date

2028-12

Last Updated

2020-11-17

Healthy Volunteers

No

Interventions

DRUG

Busulfan Injection

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