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Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

NCT01949129

RecruitingPhase 2, Phase 3

Sponsor: St. Anna Kinderkrebsforschung

Conditions: Acute Lymphoblastic Leukaemia

Interventions: VP16, TBI, Thiotepa, Treosulfan, Fludarabine

Countries: Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Croatia

The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen. The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.

Eligibility overview

Sex: ALL

Age: 1 Month to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

Patients with ALL (except for patients with B-ALL) who fulfil the following criteria:

* age at diagnosis ≤ 18 years. Age at HSCT ≤ 21 years
* indication for allogeneic HSCT
* complete remission (CR) before HSCT
* written consent of the parents (legal guardian) and, if necessary, the minor patient via "Informed Consent Form"
* no pregnancy
* no secondary malignancy
* no previous HSCT
* HSCT is performed in a study participating centre

Exclusion Criteria:

* patients who do not fulfil the inclusion criteria
* Non Hodgkin-Lymphoma
* the whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
* no consent is given for saving and propagation of anonymous medical data for study reasons
* severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
* Karnofsky / Lansky score \< 50%
* subjects unwilling or unable to comply with the study procedures
Locations (119)
  • Buenos Aires, Argentina
  • La Plata, Argentina
  • Melbourne, Australia
  • Perth, Australia
  • Randwick, Australia
  • South Brisbane, Australia
  • Sydney, Australia
  • Graz, Austria
  • Innsbruck, Austria
  • Vienna, Austria
  • Minsk, Belarus
  • Brussels, Belgium
  • Brussels, Belgium
  • Ghent, Belgium
  • Leuven, Belgium
  • Liège, Belgium
  • Calgary, Canada
  • Montral, Canada
  • Montreal, Canada
  • Toronto, Canada
  • Vancouver, Canada
  • Winnipeg, Canada
  • Santiago, Chile
  • Zagreb, Croatia
  • Prague, Czechia
  • Copenhagen, Denmark
  • Helsinki, Finland
  • Bordeaux, France
  • Clermont-Ferrand, France
  • Grenoble, France
  • + 89 more on CT.gov