NCT01596699

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 3 Months – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myeloid Malignancy
• Bone Marrow Failure Syndrome
• Transfusion-dependent Red Blood Cell (RBC) Defect
• Congenital Immunodeficiency
• Metabolic Disease
• Severe Immune Dysregulation

Interventions

Type	Name	Description
DRUG	Alemtuzumab	0.5 mg/kg (max 15 mg or max 6 mg), IV, Day -12 to Day -10 pre-HCT
DRUG	Busulfan	0.8 mg/kg/dose q6hrs or 1.1 mg/kg/dose q6hrs, IV, Day -9 to Day -6 pre-HCT
DRUG	Fludarabine	40 mg/m2 or 1.33 mg/kg, IV, Day -5 to Day -2 pre-HCT
DRUG	Clofarabine	10 mg/m2 or 0.33 mg/kg, IV, Day -5 to Day -2 pre-HCT

Timeline

• Start date: 2012-05-24
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2012-05-11
• Last updated: 2020-02-26
• Results posted: 2020-02-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study