Status:
COMPLETED
A Study of Children With Refractory or Relapsed ALL
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
Brief 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 lymphobl...
Detailed Description
The present protocol will compare the biologic effects of PEG-asparaginase vs native-forms of asparaginase in a randomized trial using the same dosages and schedules used in the POG 9411 study. Compre...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00187083
Start Date
February 1 1997
End Date
December 1 2003
Last Update
June 4 2008
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105