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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00606723
Other study ID # AML SCT-BFM 2007
Secondary ID 2007-004517-34
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2010
Est. completion date February 24, 2021

Study information

Verified date March 2021
Source Hannover Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 154
Est. completion date February 24, 2021
Est. primary completion date February 24, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 21 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Austria Graz University Hospital Graz
Austria Innsbruck University Hospital Innsbruck
Austria St. Anna Children Hospital Wien
Czechia Teaching Hospital Motol Prag
Germany Charité Campus Rudolf Virchow Hospital Berlin
Germany Carl Gustav Carus University Children's Hospital Dresden Dresden Saxony
Germany Düsseldorf University Hospital Düsseldorf North Rhine-Westphalia
Germany University Children's Hospital Erlangen-Nürnberg Erlangen Bavaria
Germany University Hospital Essen Essen North Rhine-Westphalia
Germany J.W. Goethe University Hospital and Faculty of Medicine Frankfurt Hesse
Germany University Hospital Freiburg Freiburg Baden-Württemberg
Germany Gießen University Hospital Gießen Hesse
Germany University Hospital Greifswald Greifswald Mecklenburg-West Pomerania
Germany University Children's Hospital Halle Halle Saxony-Anhalt
Germany Hamburg-Eppendorf University Hospital Hamburg
Germany Hannover Medical School, Department of Paediatrics, Paediatric Hematology and Oncology Hannover Lower Saxony
Germany Heidelberg University Hospital Heidelberg Baden-Württemberg
Germany University Children's Hospital Jena Jena Thuringia
Germany University Hospital Kiel Kiel Schleswig-Holstein
Germany Dr. von Haunersches Kinderspital München Bavaria
Germany Münster University Hospital Münster North Rhine-Westphalia
Germany University Children's Hospital Tübingen Tübingen Baden-Württemberg
Germany University Children's Hospital Ulm Ulm Baden-Württemberg
Germany University Hospital Würzburg Würzburg Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Hannover Medical School

Countries where clinical trial is conducted

Austria,  Czechia,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate whether stem cell transplantation (SCT) from a matched sibling donor (MSD) is equivalent to a matched unrelated donor (MUD) in second complete remission (CR2). day 100
Primary To evaluate whether "FLAMSA" increases leukemia free survival (LFS) and overall survival (OS) as compared to a historic control group day 100
Primary To evaluate whether SCT from haploidentical donors for children having no matched donor will result in an acceptable toxicity profile and a better LFS as compared to historic controls. day 100
Secondary Prospective evaluation of event free survival (EFS), LFS, and OS after SCT from either a MSD or a MUD day 100
Secondary To evaluate whether it is feasible to standardize transplantation procedures in children with AML within the AML-Berlin/Frankfurt/Münster (BFM) study network day 100
Secondary Decrease of transplantation associated mortality by standardized donor selection criteria day 100
Secondary To further evaluate the contribution of immunomediated effects for the treatment of children suffering from very high risk AML day 100
Secondary Prospective evaluation of late toxicities day 100 and year 5
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