AML SCT-BFM 2007

Author:  Julia Dobke, erstellt am 2010/05/12, Last modification:  2017/05/24

AML SCT-BFM 2007 Allogeneic stem cell transplantation for children, adolescents and young adults with relapsed or refractory Acute myleoblastic Leukaemia
Disease Relapsed Acute myeloblastic Leukaemia (AML)
Type Non randomized multi center study aiming for therapy optimization
Problem / Objectives

Study objectives

  1. To evaluate whether stem cell transplantation from a matched sibling donor is equivalent to a matched unrelated donor in a second complete remission.
  2. To evaluate whether “FLAMSA” increases survival as compared to a survival rate estimated from historical data (studies AML-BFM and Relapsed AML 2001/1, 1-year pSurvival 10%) in children suffering from refractory AML or relapsed AML responding poorly to reinduction therapy.
  3. To evaluate whether stem cell transplantation from haploidentical donors for children having no matched donor increases survival as compared to a survival rate estimated from historical data (studies AML-BFM and Relapsed AML 2001/1) in children suffering from refractory AML or relapsed AML .
Therapy / Study arms
  1. Young patients achieving a second complete remissio (CR2) after reinduction will undergo SCT if a matched related donor or a matched unrelated donor is available. The reparative regimen will consist of Bu/Cy Mel +/- ATG.
  2. Young patients achieving CR2 after reinduction may qualify for haploidentical stem cell transplantation if no matched related donor or matched unrelated donor is available. The preparative regimen will consist of Flud/TT/Mel (OKT3).
  3. Young patients with newly diagnosed refractory AML* will qualify for “FLAMSA” if a matched related donor or a matched unrelated donor is available. The same group will qualify for haploidentical SCT in combination with 2-CDA/Cytarabine if no matched related donor/matched unrelated donor is available for SCT 8 weeks after criteria of refractory AML are met.
  4. Young patients with relapsed AML will qualify for “FLAMSA” if the following two requirements are met: a) The bone marrow aspirate performed on day 28 after reinduction will still contain > 20% blasts, b) Availability of a matched related/matched unrelated donor.
  5. Young patients with relapsed AML will qualify for SCT from a haploidentical donor if the following requirements are met: a) No availability of a matched related/matched unrelated donor for SCT 8 weeks after diagnosis.
Inclusion Criteria
  • Aged between 0-21 years
  • Patients suffering from either refractory de novo AML or relapsed AML
  • Contraception of female adolescents and young adults or male partners
  • Written informed consent of patient, parents or legal guardians
Exclusion Criteria
  • Severely impaired functional performance (Karnofsky score < 70%, Lansky play score < 70%)
  • Severe renal impairment (GFR < 30% predicted for age)
  • Pregnant or lactating females
  • Current participation in another clinical trial
Recruitment ca 40 per year
Status 03.05.2010
EudraCT 2007-004517-34
Entry Study Register
Principal Investigator PD Dr. Martin Sauer
Contact

Investigator

Prof. Dr. med. Martin Sauer Medizinische Hochschule Hannover Kinderheilkunde, Päd. Hämatologie u. Onkologie Carl-Neuberg-Straße 1 30625 Hannover Telefon +49 (0511) 532 3220 Fax +49 (0511) 532 9120 sauer.martin@mh-hannover.de

Trial-Coordiantion

Kirsten Mischke Medizinische Hochschule Hannover Päd. Onkologie und Hämatologie Carl-Neuberg-Str. 1 30625 Hannover Telefon +49(511) 532 9467, ...9408 / 7883 Fax +49(511)532 169467 kinderKMT.doku@mhhhannover.de

Internationally participating groups

Prof. Dr. Christina Peters St. Anna Kinderspital Zimmermann Platz 10 A-1090 Wien Telefon +43 (1) 40170 3100 Fax +43 (1) 40170 7430 Christina.Peters@stanna.at

OA Dr. med. et phil II Jean-Pierre Bourquin Universitäts-Kinderklinik Zürich Onkologie / KMT Steinwiesstraße 75 8032 Zürich Telefon +41 (1) 266 7304 Fax +41 (1) 266 7171 jean-pierre.bourquin@kispi.uzh.ch

Participants Dr. Petr Sedlacek, Teaching Hospital Motol, 2nd Medical School, V Uvalu 84, 15006 Praha 5, Czech Republic Phone: +42 (0)224-436552, Fax: +42 (0)224-436519 Email: petr.sedlacek@lfmotol.cuni.cz