Clinical trial NCT00606723: Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML
Official title: Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML; Multi Center Therapy Concept
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia (AML)
Keywords: relapsed or refractory AML
in children, adolescents and young adults
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2008-02-04
Enrollment: 154
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Target variables:

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

Eligibility criteria: 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)

Primary outcomes:
measure: 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).
timeFrame: day 100
measure: To evaluate whether "FLAMSA" increases leukemia free survival (LFS) and overall survival (OS) as compared to a historic control group
timeFrame: day 100
measure: 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.
timeFrame: day 100
Secondary outcomes:
measure: Prospective evaluation of event free survival (EFS), LFS, and OS after SCT from either a MSD or a MUD
timeFrame: day 100
measure: To evaluate whether it is feasible to standardize transplantation procedures in children with AML within the AML-Berlin/Frankfurt/Münster (BFM) study network
timeFrame: day 100
measure: Decrease of transplantation associated mortality by standardized donor selection criteria
timeFrame: day 100
measure: To further evaluate the contribution of immunomediated effects for the treatment of children suffering from very high risk AML
timeFrame: day 100
measure: Prospective evaluation of late toxicities
timeFrame: day 100 and year 5
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Graz University Hospital
city: Innsbruck
country: Austria
facility: Innsbruck University Hospital
city: Wien
country: Austria
facility: St. Anna Children Hospital
city: Prag
country: Czechia
facility: Teaching Hospital Motol
city: Freiburg
country: Germany
facility: University Hospital Freiburg
state: Baden-Württemberg
city: Heidelberg
country: Germany
facility: Heidelberg University Hospital
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: University Children's Hospital Tübingen
state: Baden-Württemberg
city: Ulm
country: Germany
facility: University Children's Hospital Ulm
state: Baden-Württemberg
city: Erlangen
country: Germany
facility: University Children's Hospital Erlangen-Nürnberg
state: Bavaria
city: München
country: Germany
facility: Dr. von Haunersches Kinderspital
state: Bavaria
city: Würzburg
country: Germany
facility: University Hospital Würzburg
state: Bavaria
city: Frankfurt
country: Germany
facility: J.W. Goethe University Hospital and Faculty of Medicine
state: Hesse
city: Gießen
country: Germany
facility: Gießen University Hospital
state: Hesse
city: Hannover
country: Germany
facility: Hannover Medical School, Department of Paediatrics, Paediatric Hematology and Oncology
state: Lower Saxony
city: Greifswald
country: Germany
facility: University Hospital Greifswald
state: Mecklenburg-West Pomerania
city: Düsseldorf
country: Germany
facility: Düsseldorf University Hospital
state: North Rhine-Westphalia
city: Essen
country: Germany
facility: University Hospital Essen
state: North Rhine-Westphalia
city: Münster
country: Germany
facility: Münster University Hospital
state: North Rhine-Westphalia
city: Halle
country: Germany
facility: University Children's Hospital Halle
state: Saxony-Anhalt
city: Dresden
country: Germany
facility: Carl Gustav Carus University Children's Hospital Dresden
state: Saxony
city: Kiel
country: Germany
facility: University Hospital Kiel
state: Schleswig-Holstein
city: Jena
country: Germany
facility: University Children's Hospital Jena
state: Thuringia
city: Berlin
country: Germany
facility: Charité Campus Rudolf Virchow Hospital
city: Hamburg
country: Germany
facility: Hamburg-Eppendorf University Hospital
Study officials:
affiliation: Hannover Medical School
name: Martin Sauer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: