A Study of Children With Refractory or Relapsed ALL

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to find out which form of asparaginase (the native E. coli/Erwinia) or PEG-asparaginase) is more effective during induction treatment for children with acute lymphoblastic leukemia that has come back after treatment (relapsed) or is resistant to treatment (refractory)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Treatments: 6-Mercaptopurine; Asparaginase; Dexamethasone; Etoposide; Fludarabine; Idarubicin; Mercaptopurine; Methotrexate; Pegaspargase; Teniposide; Topotecan; Vincristine

Criteria

Inclusion Criteria

For patients treated on frontline protocols at St. Jude:

• ALL in isolated bone marrow relapse, or combined marrow and extramedullary relapse, during or after treatment with multi-agent chemotherapy (TOTAL XI, XII, XIIIA, XIIIB), or isolated extramedullary relapse after treatment on TOTXII.

• Patients with recurrent T-Cell non-Hodgkin's lymphoma who relapse in the bone marrow with >25% blasts

For patients not treated on front-line St. Jude protocols:

• ALL in isolated bone marrow relapse, or isolated extramedullary relapse, or combined marrow and extramedullary relapse.

All patients:

• First relapse after receiving primary therapy or during primary therapy

• Life expectance of at least 8 weeks

• ECOG score 0-2 Exclusion criteria

• Life expectancy < 8 weeks