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Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

NCT00075725 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3154

Last updated 2021-04-27

Study results available
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Summary

This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.

Conditions

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT, SC, or IV

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Dexamethasone

Given PO or IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Leucovorin Calcium

Given IV

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IT or IV

DRUG

Pegaspargase

Given IM

DRUG

Prednisone

Given PO or IV

RADIATION

Radiation Therapy

Undergo radiation therapy

DRUG

Thioguanine

Given PO

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Eric C Larsen · Children's Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2003-12-29
Primary Completion
2010-12-31
Completion
2021-03-31

Countries

  • United States
  • Australia
  • Canada
  • New Zealand
  • 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 NCT00075725 on ClinicalTrials.gov