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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00015217

Enrollment

Registered

2018-10-31

Start date

2018-11-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelofibrosis D47.1

Interventions

Group 1: 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

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Germany

Contacts

Public ContactAdrin Dadkhah

Klinikapotheke / Hospital Pharmacy

a.dadkhah@uke.de015222889676

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026