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Etoposide phosphate

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Alkylating Agents

patients with a MSD receive a conditioning of total body irradiation (TBI) (12 Gy, 6 fractions) and VP16 60mg/kg for one day (-3)

patients with a HLA (Human Leukocyte Antigen) matched unrelated Donor (9/10 oder 10/10) receive total body irradiation (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 mismatched donor 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

patients with MSD receive as conditioning VP16 60mg/kg/d on day -3

VP16

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

VP16, ATG

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 20mg/kd/d on day -3 to day -1, Treosulfan 14g/m²/d on day -7 to -5 and Thiotepa 2x5mg/kg/d on day -4

Fludarabine, OKT3, Treosulfan, Thiotepa

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

Arend v. Stackelberg, MD, PhD

Martin Schrappe, MD, Prof.

With this protocol the ALL-SZT BFM international study group wants

to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family or unrelated matched donors (MD) is equivalent to the HSCT from matched sibling donors (MSD).

to evaluate the efficacy of haematopoietic stem cell transplantation (HSCT) from mismatched family or unrelated mismatched donors (MMD) as compared to HSCT from matched sibling donor (MSD) and matched donor (MD).

to determine whether therapy has been carried out according to the main haematopoietic stem cell transplantation (HSCT) protocol recommendations. The standardisation of the treatment options during haematopoietic stem cell transplantation (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 haematopoietic stem cell transplantation (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.

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

Evaluation of the incidence and severity of acute Grade I-IV Graft-versus-Host-Disease (GvHD) and of limited or extensive chronic GvHD

valuation of organ dysfunctions according to WHO Toxicity score

evaluation of growth retardation and endocrine dysfunction

Evaluation of incidence of aseptic bone necrosis

Evaluation of incidence of secondary cancer after total body irradiation (TBI) and/or chemotherapy

International BFM Study Group

St. Anna Kinderkrebsforschung

MD, PHD

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

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

Christina Peters Peters, Prof MD PHD

Petr Sedlacek, Prof. MD

Marianne Ifversen, MD

Jean-Hugues Dalle, Prof. MD

Jerry Stein, Prof. MD

Adriana Balduzzi, MD

Marc Bierings, MD

Jacek Wachowiak, MD, Prof.

Sabina Sufliarska, MD

Jacek Toporski, MD

Sema Anak, Prof MD

Akif Yesilipek, MD Prof

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).

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.

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

Event-free and overall survival after allogeneic HSCT

evaluation of the incidence and severity of acute Grade I-IV graft versus Host disease and of limited or extensive chronic graft versus host disease

evaluation of organ dysfunctions according to WHO Toxicity score

Evaluation of incidence of aseptic bone necrosis.

Evaluation of incidence of secondary cancer after total body irradiation and/or chemotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia	NCT01423747	Lymphoblastic L...	VP16 TBI VP16, ATG TBI Fludarabine, OK... VP16, ATG TBI	3 Months - 18 Years	St. Anna Kinderkrebsforschung
ALL-SCT BFM International- HSCT in Children and Adolescents With ALL	NCT01423500	Lymphoblastic L...	VP16 TBI VP16, ATG TBI Fludarabine, OK... VP16, ATG TBI	3 Months - 18 Years	St. Anna Kinderkrebsforschung

Spots Global Cancer Trial Database for fludarabine, okt3, treosulfan, thiotepa