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Clinical Trials/NCT00187083
NCT00187083CompletedPhase 3

A Study of Children With Refractory or Relapsed Acute Lymphoblastic Leukemia (ALLR16)

St. Jude Children's Research Hospital1 site in 1 country40 target enrollmentStarted: February 1997Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
To compare in a randomized trial the depletion of asparagine in patients who receive the native form of asparaginase or PEG-asparaginase during induction therapy.

Study Overview

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 lymphoblastic leukemia that has come back after treatment (relapsed) or is resistant to treatment (refractory)

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. Comprehensive studies, including the measurement of antibodies and asparagine levels as well as the pharmacokinetics of L-asparaginase, will be performed. This protocol will also study the changes in topoisomerase I and topoisomerase II levels and the fractions of topoisomerase I/II translocations in malignant lymphoblasts after upfront window topotecan therapy, and correlate oncolytic response with these changes.

Secondary objectives include:

  • To compare changes in asparagine levels 28 days after initiation of treatment with asparaginase between the two groups.
  • To estimate the pharmacokinetics of L-asparaginase, compare the pharmacokinetics between the two groups of patients, and correlate the pharmacokinetics with the development of antibody to asparaginase and depletion of asparagine.
  • To measure the pharmacokinetics and pharmacodynamics of topotecan in patients with recurrent acute lymphoblastic leukemia
  • To determine whether the frequency of recombinogenesis in lymphocytes is increased during or after etoposide therapy relative to the pre-therapy level, and to explore whether etoposide pharmacokinetics are related to the Day 7 or post-therapy level of recombinogenesis.

Detailed Description of Treatment Plan

WINDOW Topotecan 2.4 mg/m2 ; IV over 30 min in 5 doses Days 1-5

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

1

Experimental

Native asparaginase

Intervention: Topotecan, dexamethasone, vincristine (Drug)

1

Experimental

Native asparaginase

Intervention: E. coli Asparaginase, PEG-L-asparaginase (Drug)

1

Experimental

Native asparaginase

Intervention: erwinia asparaginase (Drug)

1

Experimental

Native asparaginase

Intervention: fludarabine, methotrexate, mercaptopurine (Drug)

1

Experimental

Native asparaginase

Intervention: idarubicin, etoposide, cytarbine, teniposide (Drug)

1

Experimental

Native asparaginase

Intervention: chemotherapy, intrathecal chemotherapy, steroid therapy (Procedure)

2

Experimental

PEG-asparaginase

Intervention: Topotecan, dexamethasone, vincristine (Drug)

2

Experimental

PEG-asparaginase

Intervention: E. coli Asparaginase, PEG-L-asparaginase (Drug)

2

Experimental

PEG-asparaginase

Intervention: erwinia asparaginase (Drug)

2

Experimental

PEG-asparaginase

Intervention: fludarabine, methotrexate, mercaptopurine (Drug)

2

Experimental

PEG-asparaginase

Intervention: idarubicin, etoposide, cytarbine, teniposide (Drug)

2

Experimental

PEG-asparaginase

Intervention: chemotherapy, intrathecal chemotherapy, steroid therapy (Procedure)

Outcomes

Primary Outcomes

To compare in a randomized trial the depletion of asparagine in patients who receive the native form of asparaginase or PEG-asparaginase during induction therapy.

Time Frame: December 2003

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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