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A Safety and Tolerability Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Acute Lymphoblastic Leukemia (ALL)

2014-08-27 03:18:48 | BioPortfolio

Summary

This is an open-label study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine to assess this 5-drug treatment's safety and tolerability in pediatric patients with first relapse Acute Lymphoblastic Leukemia (ALL).

Description

The trial is a Phase I, open-label study to assess the safety and tolerability of incorporating clofarabine into an intensive chemotherapy regimen of etoposide, cyclophosphamide, pegylated E.coli asparaginase (PEG-asparaginase), and vincristine. Patients enrolled in this study will receive a maximum of 2 cycles of the 5-drug regimen, then will be treated according to investigator discretion. After the study treatment period, all patients will be followed for a maximum of 2 years beyond the final study visit. Types and timing of assessments may differ based on the patient's response status. This study will include a maximum of 12 evaluable patients.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Lymphoblastic Leukemia, Acute, Childhood

Intervention

Clofarabine incorporated into a 5-drug regimen

Location

Children's Hospital Los Angeles
Los Angeles
California
United States
90027

Status

Recruiting

Source

Genzyme

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:48-0400

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