NCT01423500

ALL-SCT BFM International- HSCT in Children and Adolescents With ALL

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 405 (estimated)
• Sponsor: St. Anna Kinderkrebsforschung · Academic / Other
• Sex: All
• Age: 3 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

With this protocol the ALL-SCT BFM international study group wants * to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). * to evaluate the efficacy of hematopoietic stem cell transplantation (HSCT)from mismatched family or unrelated donors (MMD) as compared to HSCT from matched sibling donors or matched donors. * to determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. * to prospectively evaluate and compare the incidence of acute and chronic Graft-versus-Host-Disease (GvHD) after HSCT from matched sibling donor (MSD), from matched donor (MD) and from mismatched donor (MMD).

Detailed description

Patients with high risk or relapsed acute lymphoblastic leukaemia (ALL) have a worse prognosis compared to all other patients with ALL. For these patients additional therapy approaches are required after they have achieved remission with multimodal chemotherapy. Allogeneic haematopoetic stem cell transplantation shows promising results mainly due to an immunological antileukaemic control by the graft-versus-leukaemia effect but treatment related mortality and morbidity remains a serious problem.

Conditions

• Lymphoblastic Leukemia, Acute, Childhood;

Interventions

Type	Name	Description
DRUG	VP16	patients with MSD receive as conditioning VP16 60mg/kg/d on day -3
RADIATION	TBI	patients with a MSD receive TBI (12Gy in 6 fractions) as conditioning
DRUG	VP16, ATG	patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive VP16 60mg/kg/d on day -3 and ATG fresenius 20mg/kg/d on day -3,-2,-1
RADIATION	TBI	patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive TBI (12Gy in 6 fractions)
DRUG	Fludarabine, OKT3, Treosulfan, Thiotepa	patients with a MMD (haploidentical or cord blood) receive Fludarabine 30mg/m²/d on day -9 to -5, ATG fresenius 20mg/kg/d on day -3,-2,-1, Treosulfan 14g/m²/d on day -7 to -5 and Thiotepa 2x5mg/kg/d on day -4
DRUG	VP16, ATG	patients with MMD-transplantation (8/10)receive VP16 60mg/kg/d on day -4, ATG from day -3 to day-1 20mg/kg/d
RADIATION	TBI	patients with a MMD-transplantation (8/10) receive 12 Gy in 6 fractions

Timeline

• Start date: 2007-01-01
• Primary completion: 2011-09-01
• Completion: 2016-09-01
• First posted: 2011-08-26
• Last updated: 2015-06-26

Locations

24 sites across 11 countries: Austria, Czechia, Denmark, France, Israel, Italy, Netherlands, Poland, Slovakia, Sweden, Turkey (Türkiye)