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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Treatment

Approved-not yet active

21 and under

Other

AML SCT-BFM 2007
EudraCT: 2007-004517-34, NCT00606723

Trial Description

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.

Further Study Information

Target variables:

Treatment response

Event Free Survival

Leukemia Free Survival

Graft Versus Host Disease

Regimen related toxicity

Eligibility Criteria

Inclusion Criteria:

Children, adolescents and young adults aged 0-21 years, male and female

Patients suffering from refractory de novo AML

Patients with relapsed AML

Patients with secondary AML

Exclusion Criteria:

Severely impaired functional performance

Severe renal impairment

Pregnancy

Trial Contact Information

Trial Lead Organizations/Sponsors

Medizinische Hochschule Hannover

Martin Sauer, PD

Principal Investigator

Martin Sauer, PD		Ph: +49-511-532-3221
		Email: sauer.martin@mh-hannover.de

Arndt Borkhardt, Prof.		Ph: +49-211-8117680
		Email: arndt.borkhardt@med.uni-duesseldorf.de

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00606723
Information obtained from ClinicalTrials.gov on July 16, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.