drugset
drugset / Trial / NCT01596699

Pilot Trial of Clofarabine Added to Standard Busulfan and Fludarabine for Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation

NCT01596699 ↗

Phase 2 Terminated 16 enrolled University of California, San Francisco
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to find out what effects, good and/or bad, the addition of clofarabine, a new chemotherapy agent, to a standard busulfan and fludarabine conditioning treatment has. The study will also look at what causes some people to have high drug levels of these medications in their body compared to other people that may have low drug levels even if they all receive the same dose of medication.

Timeline

Start
2012-05-24
Primary completion
2019-06
Completion
2019-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule 0.8 mg/kg Intravenous
Subject Busulfan Small molecule 1.1 mg/kg Intravenous
Subject Clofarabine Other / unclassified 0.33 mg/kg Intravenous
Subject Clofarabine Other / unclassified 10 mg/m2 Intravenous
Subject Fludarabine Small molecule 1.33 mg/kg Intravenous
Subject Fludarabine Small molecule 40 mg/m2 Intravenous
Background Alemtuzumab Monoclonal antibody 0.5 mg/kg Intravenous

Indications

anemia bone marrow failure syndrome immune dysregulation, autoimmunity, and autoinflammation immunodeficiency disease metabolic disease myeloid neoplasm