Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT00991133
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 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.
Study:
NCT00991133
Study Brief:
Protocol Section:
NCT00991133