Trial Information
Therapy Protocol ALL SCT BFM International-Open, Multicenter, Controlled, Prospective Study for Therapy and Therapy Optimisation in Patients With Acute Lymphoblastic Leukemia (ALL) and an Indication for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Inclusion Criteria:
all patients with ALL (except for patients with B-ALL) who fulfil the following criteria:
- age at time of initial diagnosis or relapse diagnosis, respectively
≤18 years
- indication for allogeneic HSCT
- complete remission (CR) is achieved before SCT
- written consent of the parents (legal guardian) and, if indicated, 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:
- not signed inform consent of the parents (legal guardian)
- pregnancy
- secondary malignancy
- previous HSCT
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
event-free and overall survival after allogeneic HSCT, occurrence of acute and chronic Graft-versus-Host-Disease (GvHD), occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT
Outcome Time Frame:
11 years
Safety Issue:
Yes
Authority:
Israel: Ministry of Health
Study ID:
ALL-SCT-BFM-0321-08-HMO-CTIL
NCT ID:
NCT00861679
Start Date:
January 2007
Completion Date:
September 2014
Related Keywords:
- Acute Lymphoblastic Leukemia
- HSCT
- ALL
- GvHD
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma