A Study of Children With Refractory or Relapsed ALL

Completed · Phase 3

Conditions studied: Acute Lymphoblastic Leukemia

In brief

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)

Key facts

Study ID

NCT00187083

Run by

St. Jude Children's Research Hospital

People needed

40

Starts

1997-02-01

Expected to finish

2003-12-01

Last updated by the study team

2008-06-04

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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