Pharmacokinetic studies of Busulfan as part of conditioning therapy prior to allogeneic hematopoietic stem cell transplantation in patients with myelofibrosis

• Conditions: Myelofibrosis; D47.1; Chronic myeloproliferative disease

• Registration Number: DRKS00015217
• Lead Sponsor: niversitätsklinikum Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-31
• Study Completion: 2020-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Patients at the University Hospital Hamburg-Eppendorf's Department of stem cell transplantation who have been diagnosed with myelofibrosis and have an indication for allogeneic hematopoietic stem cell transplantation with previous busulfan / fludarabine conditioning therapy. (Part A) +

Patients at the University Hospital Hamburg-Eppendorf's Department of stem cell transplantation who have been diagnosed with myelofibrosis and have already undergone allogeneic hematopoietic stem cell transplantation with previous busulfan / fludarabine conditioning therapy. (Part B)

Exclusion Criteria

Age <18 years,
Missing consent to participate in the study

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
busulfan plasma concentration, Development of a populationpharmacokinetic model by taking the covariates age, weight, cytogenetics, polymorphisms of GST-alpha genes, hepato- / splenomegaly, liver function and medication into consideration

Secondary Outcome Measures

Name	Time	Method
Hepatotoxicity, duration and severity of mucositis, time to engraftment, chimerism, type and grade of GvHD, survival (overall survival, PFS, TRM)