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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Lymp

Brief 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 Summary: 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.
Sponsor: Genzyme, a Sanofi Company

Current Primary Outcome: The incidence of DLTs (Dose Limiting Toxicities) experienced with 1 cycle of this 5-drug regimen in this patient population (in all patients who receive any doses of study drugs) [ Time Frame: 1 cycle ]

Original Primary Outcome: Safety: The incidence of DLTs (Dose Limiting Toxicities) experienced with 1 cycle of this 5-drug regimen in this patient population (in all patients who receive any doses of study drugs) [ Time Frame: 1 cycle ]

Current Secondary Outcome:

  • Overall toxicity profile documented by incidence of AEs, SAEs, and/or DLTs [ Time Frame: 1 cycle ]
  • Efficacy as documented by complete remission (CR), time and duration of remission, event-free survival (EFS), 4-month EFS, disease-free survival (DFS), and overall survival [ Time Frame: 2 cycles ]


Original Secondary Outcome:

  • Tolerability: overall toxicity profile documented by incidents of AEs, SAEs, and or DLTs (Dose Limiting Toxicities) [ Time Frame: 1 cycle ]
  • Efficacy as documented by complete remission (CR), time and duration or remission, event-free survival (EFS), 4-month EFS, disease-free survival (DFS), and overall survival [ Time Frame: 2 cycles ]


Information By: Sanofi

Dates:
Date Received: October 5, 2009
Date Started: October 2009
Date Completion:
Last Updated: April 29, 2015
Last Verified: April 2015