MedTrace Logo

Combination Chemotherapy Followed By Donor Bone Marrow or Umbilical Cord Blood Transplant in Treating Children With Newly Diagnosed Juvenile Myelomonocytic Leukemia

NCT00025038 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-04-11

No results posted yet for this study

Summary

Giving chemotherapy drugs, such as R115777, isotretinoin, cytarabine, and fludarabine, before a donor bone marrow transplant or an umbilical cord 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. This phase II trial is studying how well giving combination chemotherapy together with donor bone marrow or umbilical cord blood transplant works in treating children with newly diagnosed juvenile myelomonocytic leukemia

Conditions

  • Juvenile Myelomonocytic Leukemia

Interventions

DRUG

tipifarnib

Given orally

DRUG

isotretinoin

Given orally

DRUG

fludarabine phosphate

Given IV

DRUG

cytarabine

Given IV

RADIATION

radiation therapy

Undergo total body irradiation

DRUG

cyclophosphamide

Given IV

BIOLOGICAL

anti-thymocyte globulin

Given IV

PROCEDURE

allogeneic bone marrow transplantation

Undergo allogeneic bone marrow transplant

PROCEDURE

double-unit umbilical cord blood transplantation

PROCEDURE

umbilical cord blood transplantation

Undergo allogeneic cord blood transplant

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Robert Castleberry · Children's Oncology Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2007-10-31

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 NCT00025038 on ClinicalTrials.gov