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Combination Chemotherapy With or Without Peripheral Stem Cell Transplant in Treating Children With Acute Lymphoblastic Leukemia

NCT00022737 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2014-02-27

No results posted yet for this study

Summary

This phase II trial is studying how well combination chemotherapy with or without donor peripheral stem cell transplant works in treating children with acute lymphoblastic leukemia. Giving combination chemotherapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

Conditions

  • Childhood Acute Lymphoblastic Leukemia in Remission
  • Recurrent Childhood Acute Lymphoblastic Leukemia

Interventions

BIOLOGICAL

filgrastim

Given SC

DRUG

asparaginase

Given IM

DRUG

cyclophosphamide

Given IV

DRUG

cyclosporine

Given IV

DRUG

cytarabine

Given IT and IV

DRUG

daunorubicin hydrochloride

Given IV

DRUG

dexamethasone

Given orally

DRUG

etoposide

Given IV

DRUG

ifosfamide

Given IV

DRUG

imatinib mesylate

Given orally

DRUG

leucovorin calcium

Given IV or orally

DRUG

mercaptopurine tablet

Given orally

DRUG

methotrexate

Given IT, IV, and orally

DRUG

pegaspargase

Given IM

DRUG

vincristine sulfate

Given IV

PROCEDURE

allogeneic bone marrow transplantation

Undergo allogeneic bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation

PROCEDURE

peripheral blood stem cell transplantation

Undergo allogeneic bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation

PROCEDURE

umbilical cord blood transplantation

Undergo allogeneic bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation

RADIATION

radiation therapy

Undergo radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Kirk Schultz · Children's Oncology Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2006-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00022737 on ClinicalTrials.gov