Donor Stem Cell Transplant With or Without Chemotherapy in Treating Children With Primary Myelodysplastic Syndrome

NCT00047268 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2013-09-17

No results posted yet for this study

Summary

RATIONALE: Giving chemotherapy before a donor stem cell transplant 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. It is not yet known whether donor stem cell transplant is more effective with or without chemotherapy in treating primary myelodysplastic syndrome.

PURPOSE: This phase III trial is studying how well donor stem cell transplant given with chemotherapy works and compares it with donor stem cell transplant without chemotherapy in treating children with primary myelodysplastic syndrome.

Conditions

  • Leukemia
  • Myelodysplastic/Myeloproliferative Neoplasms

Interventions

DRUG

cytarabine

DRUG

mercaptopurine

OTHER

laboratory biomarker analysis

PROCEDURE

allogeneic bone marrow transplantation

PROCEDURE

biopsy

PROCEDURE

peripheral blood stem cell transplantation

Sponsors & Collaborators

  • European Working Group of MDS in Childhood

    lead OTHER

Principal Investigators

  • Charlotte Niemeyer, MD · Universitaetskinderklinik - Universitaetsklinikum Freiburg

Study Design

Purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-07-31

Countries

  • Germany

Study Locations

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Entities

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 NCT00047268 on ClinicalTrials.gov