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

NCT01596699 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-02-26

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Christopher C Dvorak, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-24
Primary Completion
2019-06-30
Completion
2019-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01596699 on ClinicalTrials.gov