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With this protocol the ALL-SCT BFM international study group wants
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSD - Matched Sibling Donor | Other | patients with a MSD receive a conditioning of TBI (12 Gy, 6 fractions) and VP16 60mg/kg for one day (-3) |
|
| MD - Matched Donor | Other | 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 |
|
| MMD - Mismatched Donor | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VP16 | Drug | patients with MSD receive as conditioning VP16 60mg/kg/d on day -3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event free survival | Event-free and overall survival after allogeneic HSCT | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients with GvHD acute and chronic Graft-versus-Host-Disease (GvHD) | 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 | 10 years |
| occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Peters Peters, Prof MD PHD | St. Anna Kinderkrebsforschung | Study Chair |
| Petr Sedlacek, Prof. MD | Department of Paediatric Haematology and Oncology. HSCT Unit Prague | Principal Investigator |
| Marianne Ifversen, MD | Paediatric Clinic II, Rigshospitalet Copenhagen | Principal Investigator |
| Jean-Hugues Dalle, Prof. MD | HSCT Unit Robert Debré Hospital Paris | Principal Investigator |
| Jerry Stein, Prof. MD | Schneider Children's Medical Center, Israel | Principal Investigator |
| Adriana Balduzzi, MD | Ospedale San Gerardo Monza | Principal Investigator |
| Marc Bierings, MD | Wilhelmina Children's Hospital Utrecht | Principal Investigator |
| Jacek Wachowiak, MD, Prof. | Department of Paediatric Oncology, Haematology and Transplantology, University of Medical Sciences Poznan | Principal Investigator |
| Sabina Sufliarska, MD | HSCT Unit, University Children's Hospital Bratislava |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Kinder- und Jugendheilkunde, Klin. Abt. f. Hämato-Onkologie | Graz | 8036 | Austria | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15812540 | Result | Peters C, Schrauder A, Schrappe M, von Stackelberg A, Stary J, Yaniv I, Gadner H, Klingebiel T; BFM Study Group, the IBFM-Study Group and the Paediatric Disease Working Party of the EBMT. Allogeneic haematopoietic stem cell transplantation in children with acute lymphoblastic leukaemia: the BFM/IBFM/EBMT concepts. Bone Marrow Transplant. 2005 Mar;35 Suppl 1:S9-11. doi: 10.1038/sj.bmt.1704835. | |
| 21195303 |
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| TBI | Radiation | patients with a MSD receive TBI (12Gy in 6 fractions) as conditioning |
|
|
| VP16, ATG | Drug | 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 |
|
|
| TBI | Radiation | patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive TBI (12Gy in 6 fractions) |
|
|
| Fludarabine, OKT3, Treosulfan, Thiotepa | Drug | 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 |
|
|
| VP16, ATG | Drug | patients with MMD-transplantation (8/10)receive VP16 60mg/kg/d on day -4, ATG from day -3 to day-1 20mg/kg/d |
|
|
| TBI | Radiation | patients with a MMD-transplantation (8/10) receive 12 Gy in 6 fractions |
|
|
evaluation of organ dysfunctions according to WHO Toxicity score |
| 10 years |
| occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT | evaluation of growth retardation and endocrine dysfunction | 10 years |
| occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT | Evaluation of incidence of aseptic bone necrosis. | 10 years |
| occurrence and course of subsequent malignancies after chemotherapy with subsequent allogeneic HSCT | Evaluation of incidence of secondary cancer after total body irradiation and/or chemotherapy | 10 years |
| Principal Investigator |
| Jacek Toporski, MD | Department of Paediatric Oncology Lund | Principal Investigator |
| Sema Anak, Prof MD | Paediatric HSCT Unit, Istanbul School of Medicine | Principal Investigator |
| Akif Yesilipek, MD Prof | Dep. of Paediatric Haematology-Oncology and HSCT, Akdeniz University School of Medicine | Principal Investigator |
| Universitätsklinik für Kinder- und Jugendheilkunde |
| Innsbruck |
| 6020 |
| Austria |
| St. Anna Children's Hospital | Vienna | A-1090 | Austria |
| Department of Paediatric Haematology and Oncology HSCT-Unit | Prague | 15006 | Czechia |
| Pediatric Clinic II, Rigshospitalet | Copenhagen | 4074 | Denmark |
| Pediatric Immuno-Hematology Unit Robert Debré Hospital | Paris | 75935 | France |
| Rambam Medical Center | Haifa | 31096 | Israel |
| Schneider Children's Medical Center of Israel | Petah Tikva | 49202 | Israel |
| Clinica Pediatrica dell'Universita di Milano Bicocca, Hospitale San Gerardo | Monza | 20052 | Italy |
| Leiden University Hospital | Leiden | 2300 | Netherlands |
| Radboud University - Nijmegen Medical Centre | Nijmegen | 6500 | Netherlands |
| Department of Paediatric Haematology and Oncology, Wilhelmina Children's Hospital | Utrecht | 3584 | Netherlands |
| University Hospital, Collegium Medicum UMK, Pediatric Hematology and Oncology | Bydgoszcz | 85-094 | Poland |
| Department of Transplantation, University Children's Hospital | Cracow | 30-663 | Poland |
| Children's University Hospital - Hematology - Oncology | Lublin | 20-093 | Poland |
| Department of Pediadric Oncology, Hematology and Transplantology, University of Medical Sciences | Poznan | 60-572 | Poland |
| Wroclaw Medical University, Dept. of Children Hematology and Oncology | Wroclaw | 50-345 | Poland |
| Department of Pediatric Bone Marrow Transplantation Unit, University Childrens´ Hospital | Bratislava | 833 40 | Slovakia |
| Department of Pediatric Oncology, Lund University Hospital | Lund | 221-85 | Sweden |
| Department of Pediatrics, Gülhane Military Medical Academy | Ankara | 06018 | Turkey (Türkiye) |
| Dept. of Paediatrics - BMT Unit, School of Medicine, University of Ankara | Ankara | 06100 | Turkey (Türkiye) |
| Department of Pediatric Hematology-Oncology and Pediatric Stem Cell Transplantation, Akdeniz University School of Medicine | Antalya | 07070 | Turkey (Türkiye) |
| Department of Pediatric Hematology, Oncology and BMT, Istanbul School of Medicine | Istanbul | 343990 | Turkey (Türkiye) |
| Pediatric BMT Centre, Ege University | Izmir | 35100 | Turkey (Türkiye) |
| Result |
| Pulsipher MA, Peters C, Pui CH. High-risk pediatric acute lymphoblastic leukemia: to transplant or not to transplant? Biol Blood Marrow Transplant. 2011 Jan;17(1 Suppl):S137-48. doi: 10.1016/j.bbmt.2010.10.005. |
| 25753432 | Result | Peters C, Schrappe M, von Stackelberg A, Schrauder A, Bader P, Ebell W, Lang P, Sykora KW, Schrum J, Kremens B, Ehlert K, Albert MH, Meisel R, Matthes-Martin S, Gungor T, Holter W, Strahm B, Gruhn B, Schulz A, Woessmann W, Poetschger U, Zimmermann M, Klingebiel T. Stem-cell transplantation in children with acute lymphoblastic leukemia: A prospective international multicenter trial comparing sibling donors with matched unrelated donors-The ALL-SCT-BFM-2003 trial. J Clin Oncol. 2015 Apr 10;33(11):1265-74. doi: 10.1200/JCO.2014.58.9747. Epub 2015 Mar 9. |
| 33242441 | Derived | Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available. |
| 31319153 | Derived | Balduzzi A, Dalle JH, Wachowiak J, Yaniv I, Yesilipek A, Sedlacek P, Bierings M, Ifversen M, Sufliarska S, Kalwak K, Lankester A, Toporski J, Di Maio L, Glogova E, Poetschger U, Peters C. Transplantation in Children and Adolescents with Acute Lymphoblastic Leukemia from a Matched Donor versus an HLA-Identical Sibling: Is the Outcome Comparable? Results from the International BFM ALL SCT 2007 Study. Biol Blood Marrow Transplant. 2019 Nov;25(11):2197-2210. doi: 10.1016/j.bbmt.2019.07.011. Epub 2019 Jul 15. |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| D014916 | Whole-Body Irradiation |
| C024352 | fludarabine |
| D016853 | Muromonab-CD3 |
| C018404 | treosulfan |
| D013852 | Thiotepa |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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