Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

Condition(s) studied

Investigational drug(s) / intervention(s)

VP16: 60 mg/kg BW,1 day in TBI/VP16 conditioning; 40 mg/kg BW in Bu/VP16/Cy conditioning

TBI: 2 x 2Gy/day , 3 days (total 12Gy)

Thiotepa: 2x5 mg/kg BW, 1 day

Treosulfan: 14g/m² BS, 3 days

Fludarabine: 30 mg/m² BS, 5 days

Busulfan: iV, dosage according therapeutic drug monitoring, 4 days

ATG Thymoglobulin: MD: ATG Thymo: 2,5mg/kg BW/d 3 days.

Cyclophosphamide: as part of conditioning 60 mg/kg BW 2 days or as GvHD Prophylaxis 50mg/kg BW/d 2 days with Mesna

Grafalon: MD: 15mg/kg BW/d 3 days MMD: 10mg/kg BW/d 3 days

Study 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

Primary outcome measure(s)

• Overall Survival (OS) Stratum 1a (randomisation TBI+ chemo-conditioning vs. chemo-conditioning only) — first: 18 months after inclusion of first patient, afterwards annually up to 10 years
  Stratum 1 - randomisation related question was closed in December 2018; patients are in active follow-up: To show that a non total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human leucocyte antigen (HLA) identical sibling donor (MSD) or a HLA matched donor (MD). The primary endpoint is the OS calculated from the date of the randomisation. Death from any cause will be considered an event.
• Event free survival (EFS) Stratum 2 (mismatched donor transplantation) — first: 18 months after inclusion of first patient, afterwards annually up to 10 years
  EFS after allogeneic HSCT. EFS calculated from date of recruitment to disease progression or relapse, secondary neoplasm and death from any cause.
• Overall Survival (OS), Stratum 1b: MSD/MD without randomisation — first: 18 months after inclusion of first patient, afterwards annually up to 10 years
  To explore the impact of risk factors on the incidence of adverse events of special interest (AESIs) and on overall survival and event free survival in the entire MSD/MD cohort

Trial sites (119)

+ 79 more sites — see the full list on the official registry below.

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