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Spots Global Cancer Trial Database for Combination Chemotherapy Followed By Stem Cell Transplant in Treating Young Patients With Progressive or Relapsed Anaplastic Large Cell Lymphoma

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Trial Identification

Brief Title: Combination Chemotherapy Followed By Stem Cell Transplant in Treating Young Patients With Progressive or Relapsed Anaplastic Large Cell Lymphoma

Official Title: Treatment Protocol for Relapsed Anaplastic Large Cell Lymphoma of Childhood and Adolescence

Study ID: NCT00317408

Conditions

Lymphoma

Study Description

Brief Summary: RATIONALE: Giving combination chemotherapy and total-body irradiation before a peripheral stem cell transplant that uses the patient's or a donor's stem cells, helps stop both the growth of cancer cells and the patient's immune system from rejecting the stem cells. When the stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy and total-body irradiation followed by a stem cell transplant may be an effective treatment for anaplastic large cell lymphoma. PURPOSE: This clinical trial is studying how well combination chemotherapy followed by stem cell transplant works in treating young patients with progressive or relapsed anaplastic large cell lymphoma.

Detailed Description: OBJECTIVES: Primary * Improve the probability of event-free survival in children and adolescents with early progression of anaplastic large cell lymphoma (ALCL) and/or relapse of ALCL with CD3-positive immunophenotype treated with reinduction combination chemotherapy followed by allogeneic or autologous stem cell transplantation. * Determine whether a conditioning regimen comprising carmustine, etoposide phosphate, cytarabine, and melphalan (BEAM) (without total body irradiation) for autologous stem cell transplantation is an effective treatment for patients with relapsed CD3-negative ALCL occurring after the intensive phase of treatment. * Determine the impact of vinblastine in patients with late relapse of CD3-negative ALCL who have not received vinblastine during frontline therapy. Secondary * Determine overall survival and treatment-related mortality in patients treated with these regimens. * Determine acute and long-term toxicity in patients treated with these regimens. * Determine the rate of acute and chronic graft-vs-host disease in patients treated with allogeneic stem cell transplantation. OUTLINE: This is a multicenter, prospective, nonrandomized study. Patients are stratified according to time from initial diagnosis to progression/relapse, immunophenotype of lymphoma cells (CD3-positive + vs CD3-negative), stem cell donor availability (matched sibling donor vs 9/10 or 10/10 matched unrelated donor), and vinblastine during frontline therapy (yes vs no). * Group 1 (early progression): Patients receive 1 course of ICM chemotherapy followed by 1 course of ICI chemotherapy. * ICM chemotherapy: Patients receive methotrexate, cytarabine, and prednisolone intrathecally (IT) on day 1, mitoxantrone hydrochloride IV over 5 hours on days 1 and 2, carboplatin IV continuously on days 2-5 and ifosfamide IV continuously on days 2-6. * ICI chemotherapy: Patients receive methotrexate, cytarabine, and prednisolone intrathecally on day 1, idarubicin IV over 4 hours on days 1 and 2, carboplatin IV continuously on days 2-5, and ifosfamide IV continuously on days 2-6. Patients then proceed to allogeneic stem cell transplantation. * Group 2 (relapsed disease and CD3-positive lymphoma cells): Patients are stratified according to stem cell donor availability (yes vs no). * Available donor: Patients receive 2 courses of CC chemotherapy and then proceed to allogeneic stem cell transplantation. * Unavailable donor : Patients receive 2 courses of CC chemotherapy comprising dexamethasone orally or IV on days 1-5, vindesine IV on day 1, cytarabine IV over 3 hours on days 1 and 2, etoposide phosphate IV over 2 hours on days 3-5, and methotrexate, cytarabine, and prednisolone IT on day 5. Patients then receive 1 course of CVA chemotherapy comprising oral lomustine on day 1, vinblastine IV on days 1, 8, 15, and 22, and cytarabine IV over 1 hour on days 1-5. Patients undergo leukapheresis for collection of autologous peripheral blood stem cells after the first and/or second course of CC chemotherapy. Patients then proceed to autologous stem cell transplantation. * Group 3 (relapsed disease, CD3-negative immunophenotype, and received vinblastine during frontline therapy): Patients receive 2 courses of CC chemotherapy and 1 course of CVA chemotherapy as described above. Patients undergo leukapheresis for collection of autologous peripheral blood stem cells (PBSC) after the first and/or second course of CC chemotherapy. Patients then proceed to autologous stem cell transplantation. * Group 4 (late relapse, CD3-negative immunophenotype, and did not receive vinblastine during frontline therapy): Patients receive vinblastine IV once weekly for 24 months. Patients with disease progression during or relapsed disease after vinblastine therapy undergo treatment as in group 3. * Autologous stem cell transplantation (SCT): Patients receive a conditioning regimen comprising carmustine IV over 1 hour on day -7, etoposide phosphate IV over 1 hour and cytarabine IV over 30 minutes on days -6 to -3, and melphalan IV over 15 minutes on day -2. Patients undergo autologous SCT on day 0. * Allogeneic SCT: Beginning 4-6 weeks after the start of the last chemotherapy course, patients receive 1 of the following conditioning regimens based on age: * Patients \> 2 years of age undergo total body irradiation on days -7 to -5 and receive thiotepa IV over 1 hour on day -4 and etoposide IV over 4 hours on day -3. Patients undergo allogeneic SCT on day 0. * Patients ≤ 2 years of age receive oral busulfan 4 times daily on days -8 to -5, thiotepa IV over 1 hour twice on day -4, and etoposide phosphate IV over 4 hours on day -3. Patients undergo allogeneic SCT on day 0. Patients undergoing SCT from an unrelated donor also receive antithymocyte globulin IV over 4 hours on days -3 to -1. All patients receive graft-versus-host (GVHD) prophylaxis as described below. * GVHD prophylaxis: GVHD prophylaxis is administered as per donor status. * Matched sibling donor: Patients receive cyclosporine IV over 2 hours or orally on day -1 to 60 followed by a taper. * 10/10 or 9/10 matched unrelated donor: Patients receive cyclosporine IV over 2 hours or orally on days -1 to 100 followed by a taper, methotrexate IV on days 1, 3, and 6, and leucovorin calcium IV on days 2, 4, and 7. * Mismatched donor: Patients do not receive GVHD prophylaxis, however, CD3-positive lymphocytes are extracted from donor stem cells. After completion of study treatment, patients are followed periodically for 10 years. PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

St. Anna Children's Hospital, Vienna, , Austria

U.Z. Gasthuisberg, Leuven, , Belgium

University Hospital Brno, Brno, , Czech Republic

Charles University Hospital, Prague 5, , Czech Republic

Centre Leon Berard, Lyon, , France

Kinderklinik - Universitaetsklinikum Aachen, Aachen, , Germany

Klinikum Augsburg, Augsburg, , Germany

Helios Klinikum Berlin, Berlin, , Germany

Charite University Hospital - Campus Virchow Klinikum, Berlin, , Germany

Evangelisches Krankenhauus Bielfeld, Biefeld, , Germany

Kinderklinik der Universitaet Bonn, Bonn, , Germany

Staedtisches Klinikum - Howedestrase, Braunschweig, , Germany

Klinikum Bremen-Mitte, Bremen, , Germany

Klinikum Chemnitz gGmbH, Chemnitz, , Germany

Kliniken der Stadt Koeln gGmbH - Kinderkrankenhaus Riehl, Cologne, , Germany

Children's Hospital, Cologne, , Germany

Carl - Thiem - Klinkum Cottbus, Cottbus, , Germany

Vestische Kinderklinik, Datteln, , Germany

Klinikum Dortmund, Dortmund, , Germany

Universitatsklinikum Carl Gustav Carus, Dresden, , Germany

Universitaetsklinikum Duesseldorf, Duesseldorf, , Germany

Helios Klinikum Erfurt, Erfurt, , Germany

Universitaets - Kinderklinik, Erlangen, , Germany

Universitaetsklinikum Essen, Essen, , Germany

Klinikum der J.W. Goethe Universitaet, Frankfurt, , Germany

Universitaetskinderklinik - Universitaetsklinikum Freiburg, Freiburg, , Germany

Kinderklinik, Giessen, , Germany

Universitaetsklinikum Goettingen, Goettingen, , Germany

Klinik und Poliklinik Fuer Kinder-und Jugendmedizin - Universitaetsklinikum Greifswald, Greifswald, , Germany

University Medical Center Hamburg - Eppendorf, Hamburg, , Germany

Medizinische Hochschule Hannover, Hannover, , Germany

Universitaets-Kinderklinik Heidelberg, Heidelberg, , Germany

Gemeinschaftskrankenhaus, Herdecke, , Germany

Universitaetsklinikum des Saarlandes, Homburg, , Germany

Universitaets - Kinderklinik, Jena, , Germany

Staedtisches Klinikum Karlsruhe gGmbH, Karlsruhe, , Germany

Klinikum Kassel, Kassel, , Germany

University Hospital Schleswig-Holstein - Kiel Campus, Kiel, , Germany

Klinikum Kemperhof Koblenz, Koblenz, , Germany

Klinikum Krefeld GmbH, Krefeld, , Germany

Universitaets - Kinderklinik, Leipzig, , Germany

St. Annastift Krankenhaus, Ludwigshafen, , Germany

Universitaets - Kinderklinik - Luebeck, Luebeck, , Germany

Universitatsklinikum der MA, Magdeburg, , Germany

Johannes Gutenberg University, Mainz, , Germany

Staedtisches Klinik - Kinderklinik, Mannheim, , Germany

Universitaets - Kinderklinik, Marburg, , Germany

Klinikum Minden, Minden, , Germany

Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster, Muenster, , Germany

Krankenhaus Muenchen Schwabing, Munich, , Germany

Dr. von Haunersches Kinderspital der Universitaet Muenchen, Munich, , Germany

Kinderklinik Kohlhof, Neunkirchen, , Germany

Cnopf'sche Kinderklinik, Nuremberg, , Germany

Klinikum Oldenburg, Oldenburg, , Germany

Klinik St. Hedwig-Kinderklinik, Regensburg, , Germany

Kinderklinik - Universitaetsklinikum Rostock, Rostock, , Germany

Saarbrucker Winterbergkliniken, Saarbrucken, , Germany

Klinikum Schwerin, Schwerin, , Germany

Kinderklink Siegen Deutsches Rotes Kreuz, Siegen, , Germany

Johanniter-Kinderklinik, St. Augustin, , Germany

Olgahospital, Stuttgart, , Germany

Krankenanstalt Mutterhaus der Borromaerinnen, Trier, , Germany

Universitaetsklinikum Tuebingen, Tuebingen, , Germany

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm, Ulm, , Germany

Dr. Horst-Schmidt-Kliniken, Wiesbaden, , Germany

Universitaets - Kinderklinik Wuerzburg, Wuerzburg, , Germany

Helios Kliniken Wuppertal University Hospital, Wuppertal, , Germany

Our Lady's Hospital for Sick Children Crumlin, Dublin, , Ireland

Azienda Ospedaliera di Padova, Padova, , Italy

Erasmus MC - Sophia Children's Hospital, Rotterdam, , Netherlands

Akademia Medyczna im. Piastow Slaskich, Wroclaw, , Poland

Goeteborg University, Goeteborg, , Sweden

Kantonspital Aarau, Aarau, , Switzerland

Universitaets-Kinderspital beider Basel, Basel, , Switzerland

Ospedale "la Carita", Locarno, Locarno, , Switzerland

Kinderspital Luzern, Lucerne 16, , Switzerland

Ostschweizer Kinderspital, St. Gallen, , Switzerland

University Children's Hospital, Zurich, , Switzerland

Birmingham Children's Hospital, Birmingham, England, United Kingdom

Institute of Child Health at University of Bristol, Bristol, England, United Kingdom

Addenbrooke's Hospital, Cambridge, England, United Kingdom

Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom

Leicester Royal Infirmary, Leicester, England, United Kingdom

Royal Liverpool Children's Hospital, Alder Hey, Liverpool, England, United Kingdom

Middlesex Hospital, London, England, United Kingdom

Great Ormond Street Hospital for Children, London, England, United Kingdom

Royal Manchester Children's Hospital, Manchester, England, United Kingdom

Sir James Spence Institute of Child Health at Royal Victoria Infirmary, Newcastle-Upon-Tyne, England, United Kingdom

Queen's Medical Centre, Nottingham, England, United Kingdom

Oxford Radcliffe Hospital, Oxford, England, United Kingdom

Children's Hospital - Sheffield, Sheffield, England, United Kingdom

Southampton General Hospital, Southampton, England, United Kingdom

Royal Marsden - Surrey, Sutton, England, United Kingdom

Royal Belfast Hospital for Sick Children, Belfast, Northern Ireland, United Kingdom

Royal Aberdeen Children's Hospital, Aberdeen, Scotland, United Kingdom

Royal Hospital for Sick Children, Edinburgh, Scotland, United Kingdom

Royal Hospital for Sick Children, Glasgow, Scotland, United Kingdom

Childrens Hospital for Wales, Cardiff, Wales, United Kingdom

Contact Details

Name: Alfred Reiter, MD

Affiliation: University Hospital Erlangen

Role: STUDY_CHAIR

Name: Denise Williams, MD

Affiliation: Cambridge University Hospitals NHS Foundation Trust

Role:

Useful links and downloads for this trial

Clinicaltrials.gov

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