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
Plain Language Summary
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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