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A Study of Children With Refractory or Relapsed ALL

NCT00187083 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2008-06-04

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Topotecan, dexamethasone, vincristine

See Detailed Description section for details of treatment interventions.

DRUG

E. coli Asparaginase, PEG-L-asparaginase

See Detailed Description section for details of treatment interventions.

DRUG

erwinia asparaginase

See Detailed Description section for details of treatment interventions.

DRUG

fludarabine, methotrexate, mercaptopurine

See Detailed Description section for details of treatment interventions.

DRUG

idarubicin, etoposide, cytarbine, teniposide

See Detailed Description section for details of treatment interventions.

PROCEDURE

chemotherapy, intrathecal chemotherapy, steroid therapy

See Detailed Description section for details of treatment interventions.

Sponsors & Collaborators

Principal Investigators

  • Sima Jeha, MD · St. Jude Children's Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-02-28
Primary Completion
2003-12-31
Completion
2003-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00187083 on ClinicalTrials.gov