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COMPLETEDPhase 3NCT00606723

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

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 evalua...

Lead sponsor: Hannover Medical School•24 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Hannover Medical School

Target variables: * Treatment response * Event Free Survival * Leukemia Free Survival * Graft Versus Host Disease * Regimen related toxicity

Age

0 - 21 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Aged between 0-21 years
•Patients suffering from either refractory de novo AML or relapsed AML or patients with very high risk AML in CR1
•In sexually active patients two reliable contraception methods are used. This includes every combination of a hormonal contraceptive (such as injection, transdermal patch, implant, cervical ring) or of an intrauterine device(IUD) with a barrier method (e.g. diaphragm, cervical cap, or condom) or with a spermicide.
•Written informed consent of patient, parents or legal guardians

Exclusion Criteria

•Severe renal impairment (GFR \< 30% predicted for age)
•Pregnant or lactating females
•Current participation in another clinical trial
•Patients ≥ 12 years old for Group 1 ("BuCyMel") (patients younger that 12 years continue to be included)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 22, 2021Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment154

Start dateApr 2010

Last updatedMar 22, 2021

Condition

Acute Myeloid Leukemia (AML)

Locations shown

Graz University Hospital

Graz

Innsbruck University Hospital

Innsbruck

St. Anna Children Hospital

Vienna

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 22, 2021Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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