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Fludarabine-Based Conditioning for Myelofibrosis Stem Cell Transplant
NCT00572897Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2007
- Primary completion
- Aug 2011
- Countries
- 4
- Sponsor
- John Mascarenhas
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Drugs
- fludarabinemelphalan
- Conditions
- myelofibrosis (MF)
01
Overview
Phase 2, open-label trial of fludarabine and melphalan in myelofibrosis (MF) (2 arms), sponsored by John Mascarenhas. Primary endpoint: Progression-free Survival at 2 years. Started Aug 2007; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Related Donor
Fludarabine + Melphalan conditioning
Unrelated Donor
Fludarabine + Melphalan + ATG conditioning
03
Who it enrols
Patients with idiopathic, post-PV, or post-ET myelofibrosis in chronic phase (<20% blasts) with Lille score >1 or platelets <100K. Adequate organ function required.
04
Endpoints
Primary
Progression-free Survival
Secondary
Response Outcomes
Overall Survival
Absolute Neutrophil Count
Platelet Count
Transplant-related Mortality
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