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| Name | Class |
|---|---|
| International BFM Study Group | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSD - matched sibling donor | Other | patients with a MSD receive a conditioning of total body irradiation (TBI) (12 Gy, 6 fractions) and VP16 60mg/kg for one day (-3) |
|
| MD - matched donor | Other | 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 |
|
| MMD - mismatched Donor | Other | 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 |
|
| 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 and overall survival after allogeneic haematopoietic stem cell transplantation (HSCT) | 14 years |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of acute and chronic Graft-versus-Host-Disease (GvHD) | Evaluation of the incidence and severity of acute Grade I-IV Graft-versus-Host-Disease (GvHD) and of limited or extensive chronic GvHD | 14 years |
| occurrence and course of late effects after chemotherapy with subsequent allogeneic hematopoietic stem cell transplantation (HSCT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arend v. Stackelberg, MD, PhD | ALL-REZ BFM Study Center Berlin Germany | Study Chair |
| Martin Schrappe, MD, Prof. | ALL BFM study center Kiel, Germany | Study Chair |
| 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 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 |
|
|
| 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 |
|
|
valuation of organ dysfunctions according to WHO Toxicity score |
| 14 years |
| occurrence and course of late effects after chemotherapy with subsequent allogeneic hematopoietic stem cell transplantation (HSCT) | evaluation of growth retardation and endocrine dysfunction | 14 |
| occurrence and course of late effects after chemotherapy with subsequent allogeneic hematopoietic stem cell transplantation (HSCT) | Evaluation of incidence of aseptic bone necrosis | 14 years |
| occurrence and course of secondary malignancies after chemotherapy with subsequent allogeneic hematopoietic stem cell transplantation (HSCT) | Evaluation of incidence of secondary cancer after total body irradiation (TBI) and/or chemotherapy | 14 years |
| Universitätsklinik für Kinder- und Jugendheilkunde |
| Innsbruck |
| 6020 |
| Austria |
| St. Anna Kinderspital | Vienna | 1090 | Austria |
| Charité Campus Virchow- Klinikum, Klinikum der Pädiatrie, Onkologie/Hämatologie/KMT | Berlin | 13353 | Germany |
| Klinik und Poliklinik für Kinderheilkunde, Hämatologie, Onkologie | Dresden | 01307 | Germany |
| Universitätsklinikum Düsseldorf, Klinik f. Kinderonkologie, Hämatologie u. Immunologie | Düsseldorf | 40001 | Germany |
| Klinik für Kinder und Jugendliche der Universität Erlangen-Nürnberg | Erlangen | 91054 | Germany |
| Universitätsklinikum Essen, Zentrum für Kinderheilkunde, Abt. für Hämatologie/Onkologie | Essen | 45122 | Germany |
| Klinik für Kinderheilkunde III, Hämatologie und Onkologie, Johann Wolfgang Goethe Universität | Frankfurt am Main | 60590 | Germany |
| Universitätsklinikum Freiburg, Zentrum für Kinderheilkunde und Jugendmedizin, Klinik IV: Päd. Hämatologie und Onkologie | Freiburg im Breisgau | 79106 | Germany |
| Zentrum für Kinderheilkunde, Abt. Hämatologie und Onkologie | Giessen | 35385 | Germany |
| Klinkum der Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg, Uni. Klinik un Poliklinik für Kinder- und Jugendmedizin | Halle | 06097 | Germany |
| Universitätsklinikum Hamburg-Eppendorf, Kinderklinik, Abt. für Hämatologie und Onkologie | Hamburg | 20246 | Germany |
| Med. Hochschule Hannover, Päd. Hämatologie und Onkologie | Hanover | 30625 | Germany |
| Universitätskinderklinik, Päd. Hämatologie, Onkologie und Immunologie | Heidelberg | 69120 | Germany |
| Klinik für Knochenmarktransplantation | Idar-Oberstein | 55743 | Germany |
| Klinik für Kinder- und Jugendmedizin | Jena | 07724 | Germany |
| Universitätsklinikum Kiel, Klinik für Allgemeine Pädiatrie | Kiel | 24105 | Germany |
| Klinikum der Universität München, Dr. von Haunersches Kinderspital, Abt. für Hämatologie / Onkologie | München | 80337 | Germany |
| Städt. Krankenhaus München-Schwabing, Universitätskinderklinik der TU | München | 80804 | Germany |
| Universitätsklinikum Münster, Klinik und Poliklinik für Kinderheilkunde, päd. Hämatologie / Onkologie | Münster | 48149 | Germany |
| Univ.-Klinik für Kinderheilkunde und Jugendmedizin | Tübingen | 72076 | Germany |
| Universitätskinderklinik | Ulm | 89075 | Germany |
| Universitätsklinik, päd. Onkologie/Stammzelltransplantation | Würzburg | 97080 | Germany |
| 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. |
| 26869631 | Derived | Preuner S, Peters C, Potschger U, Daxberger H, Fritsch G, Geyeregger R, Schrauder A, von Stackelberg A, Schrappe M, Bader P, Ebell W, Eckert C, Lang P, Sykora KW, Schrum J, Kremens B, Ehlert K, Albert MH, Meisel R, Lawitschka A, Mann G, Panzer-Grumayer R, Gungor T, Holter W, Strahm B, Gruhn B, Schulz A, Woessmann W, Lion T. Risk assessment of relapse by lineage-specific monitoring of chimerism in children undergoing allogeneic stem cell transplantation for acute lymphoblastic leukemia. Haematologica. 2016 Jun;101(6):741-6. doi: 10.3324/haematol.2015.135137. Epub 2016 Feb 11. |
| 25605857 | Derived | Bader P, Kreyenberg H, von Stackelberg A, Eckert C, Salzmann-Manrique E, Meisel R, Poetschger U, Stachel D, Schrappe M, Alten J, Schrauder A, Schulz A, Lang P, Muller I, Albert MH, Willasch AM, Klingebiel TE, Peters C. Monitoring of minimal residual disease after allogeneic stem-cell transplantation in relapsed childhood acute lymphoblastic leukemia allows for the identification of impending relapse: results of the ALL-BFM-SCT 2003 trial. J Clin Oncol. 2015 Apr 10;33(11):1275-84. doi: 10.1200/JCO.2014.58.4631. Epub 2015 Jan 20. |
| 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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