Title
ALL-SCT BFM International- HSCT in Children and Adolescents With ALL
Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia
Phase
Phase 3Lead Sponsor
St. Anna KinderkrebsforschungStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Lymphoblastic Leukemia, Acute, Childhood;Intervention/Treatment
muromonab cd3 Anti-thymocyte Globulin (Rabbit) fludarabine thiotepa etoposide treosulfan ...Study Participants
405With 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).
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.
patients with MSD receive as conditioning VP16 60mg/kg/d on day -3
patients with a MSD receive TBI (12Gy in 6 fractions) as conditioning
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
patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive TBI (12Gy in 6 fractions)
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
patients with MMD-transplantation (8/10)receive VP16 60mg/kg/d on day -4, ATG from day -3 to day-1 20mg/kg/d
patients with a MMD-transplantation (8/10) receive 12 Gy in 6 fractions
patients with a MSD receive a conditioning of TBI (12 Gy, 6 fractions) and VP16 60mg/kg for one day (-3)
patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive TBI (12Gy in 6 fractions), VP16 60mg/kg/d on day -3 and ATG fresenius 20mg/kg/d on day -3,-2,-1
Patients with a MMD receive stem cells either from cord blood, a haploidentical donor (parent) or from a non-related donor with a match less or equal 8/10
Inclusion Criteria: age at time of initial diagnosis or relapse diagnosis, respectively under or equal 18 years indication for allogeneic hematopoietic stem cell transplantation(HSCT) complete remission before hematopoietic stem cell transplantation (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 hematopoietic stem cell transplantation (HSCT) hematopoietic stem cell transplantation (HSCT) is performed in a study participating centre. Exclusion Criteria: age at time of initial diagnosis or relapse diagnosis, respectively above 18 years no indication for allogeneic HSCT no complete remission before SCT no written consent of the parents (legal guardian) and, if necessary, the minor patient via Informed Consent Form pregnancy secondary malignancy previous HSCT HSCT is not performed in a study participating centre.
