Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
St. Anna Kinderkrebsforschung
1,800 participants
Apr 1, 2013
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria15
- 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
- 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
Interventions
60 mg/kg BW,1 day in TBI/VP16 conditioning; 40 mg/kg BW in Bu/VP16/Cy conditioning
2 x 2Gy/day , 3 days (total 12Gy)
2x5 mg/kg BW, 1 day
14g/m² BS, 3 days
30 mg/m² BS, 5 days
iV, dosage according therapeutic drug monitoring, 4 days
MD: ATG Thymo: 2,5mg/kg BW/d 3 days.
as part of conditioning 60 mg/kg BW 2 days or as GvHD Prophylaxis 50mg/kg BW/d 2 days with Mesna
MD: 15mg/kg BW/d 3 days MMD: 10mg/kg BW/d 3 days
Locations(119)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT01949129