NCT00991133

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

A Phase 1, Open-Label, Multi-Center Safety and Tolerability Pilot Combination Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL) in First Relapse

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 1 Year – 30 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The trial is a Phase 1, open-label study to assess the safety and tolerability of incorporating clofarabine into an intensive chemotherapy regimen of etoposide, cyclophosphamide, 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 minimum of 4 months beyond the final study visit. This study will include a maximum of 12 evaluable patients.

Conditions

• Lymphoblastic Leukemia, Acute, Childhood

Interventions

Type	Name	Description
DRUG	Clofarabine incorporated into a 5-drug regimen	Clofarabine (IV) 40mg/m2 into an intensive chemotherapy regimen of etoposide, cyclophosphamide, PEG-asparaginas, and vincristine

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-10-07
• Last updated: 2015-04-30

Locations

6 sites across 1 country: United States