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Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia

NCT00005585 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 838

Last updated 2023-04-06

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for childhood acute lymphoblastic leukemia.

PURPOSE: This randomized phase III trial is comparing different regimens of combination chemotherapy to see how well they work in treating children with acute lymphoblastic leukemia.

Conditions

Interventions

DRUG

cyclophosphamide

Given IV

DRUG

cytarabine

Deoxycytidine analogue which is metabolized to ARA-CTP, a substance which inhibits DNA polymerase.

DRUG

daunorubicin hydrochloride

Given IV

DRUG

dexamethasone

Dexamethasone is a synthetic fluorinated glucocorticoid devoid of mineralocorticoid effects.

DRUG

leucovorin calcium

Synthetic d,l-5 CHO tetrahydrofolate, which is used to bypass the inhibition of dihydrofolate reductase by Methotrexate (MTX)

DRUG

mercaptopurine

An analogue of the nucleic acid constituent adenine and the physiological purine base hypoxanthine

DRUG

methotrexate

A folate analogue which inhibits the enzyme dihydrofolate reductase, haltin g DNA, RNA, and protein synthesis

DRUG

pegaspargase

E-Coli asparaginase deaminates asparagine, thus, is lethal for cells which cannot synthesize asparagine.

DRUG

thioguanine

Given orally

DRUG

vincristine sulfate

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Paul L. Martin, MD · Duke Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-04-30
Primary Completion
2007-07-31

Countries

  • United States
  • Australia
  • Canada
  • Netherlands
  • Puerto Rico
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00005585 on ClinicalTrials.gov