None listed
Conditions
Brief summary
The ALL SCTped 2012 FORUM is a multinational study that explore the efficacy and efficiency of two different chemo-conditioning regimens (Flu/Thio with Treo or ivBu) in comparison to the standard conditioning regimen (TBI/VP16) for children and adolescents with Acute Lymphoblastic Leukaemia undergoing Allogeneic Stem Cell Transplantation. Who is it for? Patients with Acute lymphoblastic leukaemia diagnosed before or equal to the age of 18 and will be undergoing an Allogeneic stem cell transplantation before or equal to the age of 21. Study details: This study will compare 2 different conditioning regimens. Eligible patients will be randomised (allocated by chance) to either total body irradiation containing regimen (TBI) or to non-total body irradiation regimen (non-TBI) and this will be followed by haematopoietic stem cell transplant (HSCT). The study will compare the outcome of children with ALL who receive a total body irradiation conditioning regimen versus irradiation free conditioning followed by haematopoietic stem cell transplant (HSCT). The study will also compare the outcome after mismatched donors, haploidentical family donors or mismatched cord blood.
Interventions
This is a multinational, multi-centre, randomised, phase II/III study comparing chemo based myeloablative conditioning regimen Fludarabine/Thiotepa/Busulphan or Fludarabine/Thiotepa/Treosulfan with Total body irradiation/Etoposide prior to Hematopoetic stem cell transplantation (HSCT) for children and adolescents with Acute lymphoblastic leukaemia (ALL) in complete remission (CR).
Stratum 1 and stratum 2 -
Stratum 1: for patient who are older than age of 4 with a Human leucocyte antigen (HLA)
This is a multinational, multi-centre, randomised, phase II/III study comparing chemo based myeloablative conditioning regimen Fludarabine/Thiotepa/Busulphan or Fludarabine/Thiotepa/Treosulfan with Total body irradiation/Etoposide prior to Hematopoetic stem cell transplantation (HSCT) for children and adolescents with Acute lymphoblastic leukaemia (ALL) in complete remission (CR). Stratum 1 and stratum 2 - Stratum 1: for patient who are older than age of 4 with a Human leucocyte antigen (HLA) identical sibling donor (MSD) or a HLA matched donor (MD). Stratum 2: for patients with a HLA mismatched donors, mismatched unrelated donors (MMD), mismatched cord blood or HLA haplo-identical family members. Fludarabine/Thiotepa/Busulphan or Fludarabine/Thiotepa/Treosulfan according to country's decision. *Drug: Thiotepa 1x5 mg/kg for 2 day from day -8 of HSCT, intravenous infusion *Drug: Fludarabine 37.5 mg/m^2 intravenous infusion for 30 mins for 4 days, start on day -6 of HSCT *Drug: Busulphan intravenous infusion, dosage according therapeutic drug monitoring, for 4 days start at day -6 of HSCT. *Drug: Treosulfan 14g/m^2 for 3 days, start on day -6 from HSCT, intravenous infusion.
Sponsors
St. Anna Kinderkrebsforschung
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
All patients with ALL (except for patients with mature B-ALL) who fulfil the following criteria: - Age at diagnosis less than or equal to 18 years. Age at HSCT less than or equal to 21 years. - indication for allogeneic HSCT - complete remission (CR) before SCT - 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
- 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; Renal impairment (< 30% of normal glomerular filtration rate) Severe pulmonary, hepatic or cardial impairment due to toxicity or infection - Karnofsky / Lansky score < 50% - Subjects unwilling or unable to comply with the study procedures
Outcome results
None listed