Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML
Acute Myeloid Leukemia (AML)
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring relapsed or refractory AML, in children, adolescents and young adults
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)
Sites / Locations
- Graz University Hospital
- Innsbruck University Hospital
- St. Anna Children Hospital
- Teaching Hospital Motol
- University Hospital Freiburg
- Heidelberg University Hospital
- University Children's Hospital Tübingen
- University Children's Hospital Ulm
- University Children's Hospital Erlangen-Nürnberg
- Dr. von Haunersches Kinderspital
- University Hospital Würzburg
- J.W. Goethe University Hospital and Faculty of Medicine
- Gießen University Hospital
- Hannover Medical School, Department of Paediatrics, Paediatric Hematology and Oncology
- University Hospital Greifswald
- Düsseldorf University Hospital
- University Hospital Essen
- Münster University Hospital
- University Children's Hospital Halle
- Carl Gustav Carus University Children's Hospital Dresden
- University Hospital Kiel
- University Children's Hospital Jena
- Charité Campus Rudolf Virchow Hospital
- Hamburg-Eppendorf University Hospital
Arms of the Study
Arm 1
Experimental
1
Group I: Relapsed AML-patients with blast cell reduction to <20% before the second course of induction therapy. These patients will receive conventional SCT. Group II: Patients with non response to frontline treatment of AML, patients with blast cells <20% before the second course of induction therapy who do not achieve a second remission and relapsed AML-patients with blast cells >=20% before the second course of induction therapy. If these patients have a matched donor (MSD/MD) they will receive SCT with "FLAMSA". Group III: Patients who are eligible for Group II but have no matched donor. These patients will receive SCT from a haploidentical donor.