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

NCT00317408 | Unknown

• 14 other identifiers: CDR0000466639EICNHL-ALCL-RELAPSEAIEOP-EICNHL-ALCL-RELAPSEBFM-EICNHL-ALCL-RELAPSEBSPHO-EICNHL-ALCL-RELAPSEDCOG-EICNHL-ALCL-RELAPSENOPHO-EICNHL-ALCL-RELAPSEPPLLSG-EICNHL-ALCL-RELAPSESFCE-EICNHL-ALCL-RELAPSESHOP-EICNHL-ALCL-RELAPSECCLG-NHL-2006-01EU-205118EU-20618EUDRACT-2005-003321-57
• Study Type: interventional
• Target: 96
• Locations: 12 countries
• Sites: 98

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.

Conditions

Lymphoma

Keywords

anaplastic large cell lymphoma; recurrent childhood anaplastic large cell lymphoma; stage III childhood anaplastic large cell lymphoma; stage IV childhood anaplastic large cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Event-free survival as measured by the Kaplan-Meier method

Secondary Outcomes (5)

• Proportion of patients who are treated on protocol among all patients who meet the inclusion criteria

• Overall survival

• Acute and long term toxicity

• Rate of acute and chronic graft-vs-host disease in patients with allogeneic stem cell transplantation

• Treatment related mortality

Interventions

anti-thymocyte globulin BIOLOGICAL

busulfan DRUG

carboplatin DRUG

carmustine DRUG

cyclosporine DRUG

cytarabine DRUG

dexamethasone DRUG

etoposide phosphate DRUG

idarubicin DRUG

ifosfamide DRUG

leucovorin calcium DRUG

lomustine DRUG

melphalan DRUG

methotrexate DRUG

mitoxantrone hydrochloride DRUG

prednisolone DRUG

thiotepa DRUG

vinblastine sulfate DRUG

vindesine DRUG

allogeneic hematopoietic stem cell transplantation PROCEDURE

autologous hematopoietic stem cell transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

total-body irradiation RADIATION

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed anaplastic large cell lymphoma (ALCL) * Progressive disease OR first relapse * No second or subsequent relapse of ALCL * Slides available for national central pathology review * Availability of 1 of the following (for allogeneic stem cell transplantation only): * HLA-identical matched sibling donor * 10/10 HLA-matched nonsibling donor (related or unrelated) * 9/10 HLA-matched nonsibling donor (1-antigen-mismatched related or unrelated donor) * \< 9/10 HLA-mismatched donor (related or unrelated) * Stem cells may be obtained from unmanipulated bone marrow or peripheral blood stem cells after filgrastim (G-CSF) stimulation PATIENT CHARACTERISTICS: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Adequate hepatic, renal, and cardiac function * No HIV infection or AIDS * No severe immunodeficiency * No other prior malignancy * No pre-existing disease or condition prohibiting study treatment PRIOR CONCURRENT THERAPY: * At least 2 months since prior chemotherapy or radiotherapy * No significant pretreatment for first relapse * No prior organ transplantation * No concurrent participation in another clinical trial

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma: lead

Study Sites (98)

St. Anna Children's Hospital

Vienna, A-1090, Austria

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

University Hospital Brno

Brno, CZ-662 63, Czechia

Location

Charles University Hospital

Prague, CZ-150 06, Czechia

Location

Centre Leon Berard

Lyon, 69373, France

Location

Kinderklinik - Universitaetsklinikum Aachen

Aachen, D-52074, Germany

Location

Klinikum Augsburg

Augsburg, D-86156, Germany

Location

Helios Klinikum Berlin

Berlin, 13125, Germany

Location

Charite University Hospital - Campus Virchow Klinikum

Berlin, D-13353, Germany

Location

Evangelisches Krankenhauus Bielfeld

Biefeld, 33617, Germany

Location

Kinderklinik der Universitaet Bonn

Bonn, D-53113, Germany

Location

Staedtisches Klinikum - Howedestrase

Braunschweig, 38118, Germany

Location

Klinikum Bremen-Mitte

Bremen, D-28205, Germany

Location

Klinikum Chemnitz gGmbH

Chemnitz, D-09116, Germany

Location

Kliniken der Stadt Koeln gGmbH - Kinderkrankenhaus Riehl

Cologne, D-50735, Germany

Location

Children's Hospital

Cologne, D-50924, Germany

Location

Carl - Thiem - Klinkum Cottbus

Cottbus, D-03048, Germany

Location

Vestische Kinderklinik

Datteln, 45704, Germany

Location

Klinikum Dortmund

Dortmund, D-44137, Germany

Location

Universitatsklinikum Carl Gustav Carus

Dresden, D-01307, Germany

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, D-40225, Germany

Location

Helios Klinikum Erfurt

Erfurt, 99089, Germany

Location

Universitaets - Kinderklinik

Erlangen, D-91054, Germany

Location

Universitaetsklinikum Essen

Essen, D-45147, Germany

Location

Klinikum der J.W. Goethe Universitaet

Frankfurt, D-60590, Germany

Location

Universitaetskinderklinik - Universitaetsklinikum Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

Kinderklinik

Giessen, D-35385, Germany

Location

Universitaetsklinikum Goettingen

Göttingen, D-37075, Germany

Location

Klinik und Poliklinik Fuer Kinder-und Jugendmedizin - Universitaetsklinikum Greifswald

Greifswald, 17475, Germany

Location

University Medical Center Hamburg - Eppendorf

Hamburg, D-20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Universitaets-Kinderklinik Heidelberg

Heidelberg, D-69120, Germany

Location

Gemeinschaftskrankenhaus

Herdecke, 58313, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg, 66421, Germany

Location

Universitaets - Kinderklinik

Jena, D-07745, Germany

Location

Staedtisches Klinikum Karlsruhe gGmbH

Karlsruhe, 76133, Germany

Location

Klinikum Kassel

Kassel, D-34125, Germany

Location

University Hospital Schleswig-Holstein - Kiel Campus

Kiel, D-24105, Germany

Location

Klinikum Kemperhof Koblenz

Koblenz, D-56065, Germany

Location

Klinikum Krefeld GmbH

Krefeld, D-47805, Germany

Location

Universitaets - Kinderklinik

Leipzig, D-04317, Germany

Location

St. Annastift Krankenhaus

Ludwigshafen, 67065, Germany

Location

Universitaets - Kinderklinik - Luebeck

Lübeck, D-23538, Germany

Location

Universitatsklinikum der MA

Magdeburg, 39120, Germany

Location

Johannes Gutenberg University

Mainz, D-55101, Germany

Location

Staedtisches Klinik - Kinderklinik

Mannheim, D-68167, Germany

Location

Universitaets - Kinderklinik

Marburg, 35033, Germany

Location

Klinikum Minden

Minden, D-32423, Germany

Location

Krankenhaus Muenchen Schwabing

Munich, 80804, Germany

Location

Dr. von Haunersches Kinderspital der Universitaet Muenchen

Munich, D-80337, Germany

Location

Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster

Münster, D-48149, Germany

Location

Kinderklinik Kohlhof

Neunkirchen, D-66539, Germany

Location

Cnopf'sche Kinderklinik

Nuremberg, 90419, Germany

Location

Klinikum Oldenburg

Oldenburg, 26133, Germany

Location

Klinik St. Hedwig-Kinderklinik

Regensburg, 93049, Germany

Location

Kinderklinik - Universitaetsklinikum Rostock

Rostock, D-18057, Germany

Location

Saarbrucker Winterbergkliniken

Saarbrücken, 66119, Germany

Location

Johanniter-Kinderklinik

Sankt Augustin, 53757, Germany

Location

Klinikum Schwerin

Schwerin, D-19049, Germany

Location

Kinderklink Siegen Deutsches Rotes Kreuz

Siegen, D-57072, Germany

Location

Olgahospital

Stuttgart, D-70176, Germany

Location

Krankenanstalt Mutterhaus der Borromaerinnen

Trier, D-54290, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, D-72076, Germany

Location

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Ulm, D-89075, Germany

Location

Dr. Horst-Schmidt-Kliniken

Wiesbaden, D-65199, Germany

Location

Helios Kliniken Wuppertal University Hospital

Wuppertal, D-42283, Germany

Location

Universitaets - Kinderklinik Wuerzburg

Würzburg, D-97080, Germany

Location

Our Lady's Hospital for Sick Children Crumlin

Dublin, 12, Ireland

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Erasmus MC - Sophia Children's Hospital

Rotterdam, 3015 GJ, Netherlands

Location

Akademia Medyczna im. Piastow Slaskich

Wroclaw, 50-367, Poland

Location

Goeteborg University

Gothenburg, S-141685, Sweden

Location

Kantonspital Aarau

Aarau, CH-5001, Switzerland

Location

Universitaets-Kinderspital beider Basel

Basel, CH-4005, Switzerland

Location

Ospedale "la Carita", Locarno

Locarno, 6600, Switzerland

Location

Kinderspital Luzern

Lucerne, CH-6000, Switzerland

Location

Ostschweizer Kinderspital

Sankt Gallen, CH-9006, Switzerland

Location

University Children's Hospital

Zurich, CH-8032, Switzerland

Location

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

Middlesex Hospital

London, England, W1T 3AA, United Kingdom

Location

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, England, M27 4HA, United Kingdom

Location

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

Location

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

Related Publications (2)

• Knorr F, Zimmermann M, Bader P, Lang P, Muller I, Basu O, Burkhardt B, Seidl J, Damm-Welk C, Pichler H, Attarbaschi A, Meissner B, Beier R, Woessmann W. Allogeneic HSCT for consolidation in pediatric refractory or relapsed ALK-positive anaplastic large cell lymphoma. Blood Adv. 2026 Feb 3:bloodadvances.2025018774. doi: 10.1182/bloodadvances.2025018774. Online ahead of print.

  PMID: 41632689 DERIVED

• Knorr F, Brugieres L, Pillon M, Zimmermann M, Ruf S, Attarbaschi A, Mellgren K, Burke GAA, Uyttebroeck A, Wrobel G, Beishuizen A, Aladjidi N, Reiter A, Woessmann W; European Inter-Group for Childhood Non-Hodgkin Lymphoma. Stem Cell Transplantation and Vinblastine Monotherapy for Relapsed Pediatric Anaplastic Large Cell Lymphoma: Results of the International, Prospective ALCL-Relapse Trial. J Clin Oncol. 2020 Dec 1;38(34):3999-4009. doi: 10.1200/JCO.20.00157. Epub 2020 Jul 30.

  PMID: 32730187 DERIVED

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large-Cell, Anaplastic

Interventions

Antilymphocyte Serum; Busulfan; Carboplatin; Carmustine; Cyclosporine; Cytarabine; Dexamethasone; etoposide phosphate; Idarubicin; Ifosfamide; Leucovorin; Lomustine; Melphalan; Methotrexate; Mitoxantrone; Prednisolone; Thiotepa; Vinblastine; Vindesine; Peripheral Blood Stem Cell Transplantation; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Coordination Complexes; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Aminopterin; Anthraquinones; Anthrones; Anthracenes; Quinones; Triethylenephosphoramide; Aziridines; Azirines; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Radiotherapy; Investigative Techniques

Study Officials

• Alfred Reiter, MD

  University Hospital Erlangen

  STUDY CHAIR

• Denise Williams, MD

  Cambridge University Hospitals NHS Foundation Trust

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 19, 2006
• First Posted: April 24, 2006
• Study Start: April 1, 2004
• Primary Completion: February 1, 2014
• Last Updated: September 25, 2015

Record last verified: 2015-09

Locations

FR (1); DE (62); SE (1); BE (1); AU (1); CH (6); PL (1); IE (1); GB (20); CZ (2); NL (1); IT (1)