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Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML

NCT00606723 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2021-03-22

No results posted yet for this study

Summary

1. To evaluate whether stem cell transplantation from a matched sibling donor is equivalent to a matched unrelated donor in in a second complete remission of acute myeloid leukemia (AML).
2. To evaluate whether stem cell transplantation (SCT) after chemotherapy (FLAMSA-schema) increases survival compared to a threshold derived from historical data
3. To evaluate whether SCT from haploidentical donors for children having no matched donor will result in better survival with acceptable toxicity.

Conditions

  • Acute Myeloid Leukemia (AML)

Interventions

BIOLOGICAL

Hematopoietic stem cells from bone marrow or peripheral blood

\> = 2 x 10\*8 nucleated cells (WBC)/kg body weight of the recipient or rather \> = 4 x 10\*6 nucleated CD34+ cells / kg body weight are required for engraftment. Suspension of stem cells is administered via intravenous infusion.

Sponsors & Collaborators

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Martin Sauer, Prof. Dr. · Hannover Medical School

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2021-02-24
Completion
2021-02-24

Countries

  • Austria
  • Czechia
  • Germany

Study Locations

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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 NCT00606723 on ClinicalTrials.gov