Status:

UNKNOWN

ALL-SCT BFM International- HSCT in Children and Adolescents With ALL

Lead Sponsor:

St. Anna Kinderkrebsforschung

Conditions:

Lymphoblastic Leukemia, Acute, Childhood;

Eligibility:

All Genders

3-18 years

Phase:

PHASE3

Brief Summary

With this protocol the ALL-SCT BFM international study group wants * to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family or unrelated donors (MD) is equivalent to t...

Detailed Description

Patients with high risk or relapsed acute lymphoblastic leukaemia (ALL) have a worse prognosis compared to all other patients with ALL. For these patients additional therapy approaches are required af...

Eligibility Criteria

Inclusion

  • age at time of initial diagnosis or relapse diagnosis, respectively under or equal 18 years
  • indication for allogeneic hematopoietic stem cell transplantation(HSCT)
  • complete remission before hematopoietic stem cell transplantation (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 hematopoietic stem cell transplantation (HSCT)
  • hematopoietic stem cell transplantation (HSCT) is performed in a study participating centre.

Exclusion

  • age at time of initial diagnosis or relapse diagnosis, respectively above 18 years
  • no indication for allogeneic HSCT
  • no complete remission before SCT
  • no written consent of the parents (legal guardian) and, if necessary, the minor patient via Informed Consent Form
  • pregnancy
  • secondary malignancy
  • previous HSCT
  • HSCT is not performed in a study participating centre.

Key Trial Info

Start Date :

January 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2016

Estimated Enrollment :

405 Patients enrolled

Trial Details

Trial ID

NCT01423500

Start Date

January 1 2007

End Date

September 1 2016

Last Update

June 26 2015

Active Locations (24)

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Page 1 of 6 (24 locations)

1

Universitätsklinik für Kinder- und Jugendheilkunde, Klin. Abt. f. Hämato-Onkologie

Graz, Austria, 8036

2

Universitätsklinik für Kinder- und Jugendheilkunde

Innsbruck, Austria, 6020

3

St. Anna Children's Hospital

Vienna, Austria, A-1090

4

Department of Paediatric Haematology and Oncology HSCT-Unit

Prague, Czechia, 15006