RecruitingPhase 3NCT02858258

ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma

Autologous Transplantation After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma - a Randomized European Mcl Network Trial

Sponsor

Prof. Dr. M. Dreyling (co-chairman)

Enrollment

870 participants

Start Date

Jul 1, 2016

Study Type

INTERVENTIONAL

Conditions

Mantle Cell Lymphoma

Summary

The primary objective of the the trial is to establish one of three study arms, as future standard based on the comparison of the investigator-assessed failure-free survival.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chemotherapy drugs — including rituximab, ibrutinib, and high-dose cytarabine — followed by a stem cell transplant using the patient's own stem cells, for younger adults newly diagnosed with mantle cell lymphoma, a type of blood cancer affecting the lymph nodes. **You may be eligible if...** - You have a confirmed diagnosis of mantle cell lymphoma from a biopsy - You are between 18 and 65 years old - You have never been treated for mantle cell lymphoma before - Your disease is at stage II, III, or IV - You are healthy enough to tolerate intensive chemotherapy and a stem cell transplant - You have at least one measurable tumor site - Your blood counts and liver function tests are within acceptable ranges **You may NOT be eligible if...** - You have previously received treatment for mantle cell lymphoma - You are over 65 or under 18 years old - Your blood counts or liver function are significantly abnormal - You have other serious health conditions that prevent intensive treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGR-CHOP/R-DHAP

Drug: R-CHOP/DHAP Alternating 3x R-CHOP (Rituximab , Cyclophosphamide ,Doxorubicine ,Vincristine , Prednisone) / 3x R-DHAP (Rituximab , Dexamethasone, Ara-C, Cisplatine, G-CSF)

DRUGIbrutinib (Induction)

Ibrutinib: only in cycle 1,3,5 on Day 1-19

DRUGASCT conditioning

ASCT conditioning THAM or BEAM, stratified per site before trial activation at site THAM (TBI (total body irradiation), Ara-C, Melphalan) or BEAM (BCNU, Etoposide, Cytarabine, Melphalan)

DRUGIbrutinib (Maintenance)

Ibrutinib (Maintenance), daily 560 mg for 2 years;

Locations(112)

Aalborg University Hospital, Dept of Hematology

Aalborg, Denmark

Aarhus University Hospital, Dept of Hematology

Aarhus C, Denmark

Rigshospitalet, Clinic of Hematology

Copenhagen, Denmark

Herlev Hospital, Department of Hematology L121

Herlev, Denmark

Odense University Hospital, Dept of Hematology X

Odense C, Denmark

Sjaelland University Hospital, Dept of Hematology

Roskilde, Denmark

Zentralklinik Augsburg, II. Med. Klinik, Hämatologie int. Onkologie

Augsburg, Germany

Onkologische Gemeinschaftspraxis Dr. Janssen/Dr. Reichert in der Ubbo-Emmius-Klinik

Aurich, Germany

Klinikum Bayreuth, Klinik f. Onkologie und Hämatologie

Bayreuth, Germany

Vivantes Klinikum Am Urban, Klinik f. Innere Medizin, Hämatologie und Onkologie

Berlin, Germany

Charité Univ.-Medizin Berlin, Med. Klinik - Hämatologie, Onkologie und Tumorimmunologie

Berlin, Germany

Helios Klinikum Berlin-Buch, Hämatologie, Onkologie und Tumorimmunologie

Berlin, Germany

Knappschaftskrankenhaus Bochum-Langendreer

Bochum, Germany

Universitätsklinikum Bonn

Bonn, Germany

Diako ev. Diakonie-KH gGmbH, Med. Klinik II, Hämatologie und Onkologie

Bremen, Germany

Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin II

Chemnitz, Germany

Uniklinik Köln, Klinik I für Innere Medizin

Cologne, Germany

DONAUISAR Klinikum Deggendorf, Innere Medizin II

Deggendorf, Germany

St.-Johannes-Hospital

Dortmund, Germany

Gemeinschaftspraxis Dr. Mohm und Prange-Krex - Fachärzte für Innere Medizin und Hämatologie und Onkologie

Dresden, Germany

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, Germany

Universitätsklinikum Düsseldorf, Klinik f. Hämatologie, Onkologie und klinische Immunologie

Düsseldorf, Germany

Marien Hospital Düsseldorf

Düsseldorf, Germany

Helios Klinikum Erfurt GmbH, Zentrum f. Innere Medizin u. internistische Onkologie, Hämostaseologie

Erfurt, Germany

Universitätsklinikum Erlangen, Med. Klinik 5, Hämatologie und internistische Onkologie

Erlangen, Germany

St.-Antonius-Hospital Eschweiler, Klinik für Hämatologie und Onkologie

Eschweiler, Germany

Universitätsklinikum Essen, Klinik f. Hämatologie

Essen, Germany

Universitätsklinikum Freiburg, Klinik f. Innere Medizin, Hämatologie, Onkologie u. Stammzelltransplantation

Freiburg im Breisgau, Germany

Universitätsmedizin Göttingen, Zentrum f. Innere Medizin, Klinik f. Hämatologie und Medizinische Onkologie

Göttingen, Germany

Universitätsmedizin Greifswald, Klinik u. Poliklinik f. Innere Medizin C, Hämatologie u. Onkologie-, Transplantationszentrum

Greifswald, Germany

Katholisches Krankenhaus Hagen gGmbH, St.-Marien-Hospital, Klinik f. Hämatologie und Onkologie

Hagen, Germany

Universitätsklinikum Hamburg-Eppendorf (UKE), II. Med. Klinik u. Poliklinik, Onkologie, Hämatologie, KMT

Hamburg, Germany

Asklepios Klinik Altona, II. Med.Abt. f. Hämatologie und internistische Onkologie, Stammzelltransplantation

Hamburg, Germany

Universitätsklinikum Heidelberg, Med. Klinik - Innere Medizin V - Hämatologie, Onkologie und Rheumatologie

Heidelberg, Germany

Universitätsklinikum des Saarlandes, Klinik f. Innere Medizin I Hämatologie & Onkologie

Homburg, Germany

Klinikum Idar-Oberstein GmbH, Medizinische Klinik I

Idar-Oberstein, Germany

Universitätsmedizin Jena, Klinik f. Innere Medizin II, Abteilung Hämatologie u. Internistische Onkologie

Jena, Germany

Städtisches Klinikum Karlsruhe, Med. Klinik III, Hämatologie und Onkologie

Karlsruhe, Germany

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik f. Innere Medizin II - Hämatologie und Onkologie

Kiel, Germany

Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin, Klinik f. Innere Medizin

Koblenz, Germany

Praxisklinik f. Hämatologie und Onkologie Koblenz

Koblenz, Germany

Onkologisch-Hämatologische Praxis Dr. Vehling-Kaiser

Landshut, Germany

Klinikum Landshut gGmbH, Med. Klinik III, Hämatologie/Internistische Onkologie

Landshut, Germany

Caritas-KHLebach, Gemeinschaftspraxis f. Hämatologie und Onkologie, Onkologisches Zentrum Lebach

Lebach, Germany

Universitätsklinikum Leipzig AöR, selbständige Abteilung f. Hämatologie und Internistische Onkologie, Hämostaseologische Ambulanz

Leipzig, Germany

Klinikum Lippe GmbH, Onkologie und Hämatologie

Lemgo, Germany

Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Med. Klinik A

Ludwigshafen, Germany

Universitätsklinikum Magdeburg AöR, Klinik f. Hämatologie und Onkologie

Magdeburg, Germany

Universitätsmedizin der Univ. Mainz, III. Med. Klinik u. Poliklinik

Mainz, Germany

Johannes Wiesling Klinikum Minden, Klinik f. Hämatologie/Onkologie, Hämostaseologie und Palliativmedizin

Minden, Germany

Klinikum der Universität München, Med. Klinik und Poliklinik III

München, Germany

Klinikum Rechts der Isar, III. Med. Klinik - Hämatologie und Onkologie

München, Germany

Universitätsklinikum Münster, Med. Klinik A, Translationale Onkologie / Lymphome

Münster, Germany

Klinikum Nürnberg,5. Medizinische Klinik, Onkologie / Hämatologie

Nuremberg, Germany

Klinikum Oldenburg gGmbH, Med. Klinik II

Oldenburg, Germany

Klinikum Ernst von Bergmann Potsdam gGmbH, Zentrum f. Innere Medizin, Klinik f. Hämatologie und Onkologie

Potsdam, Germany

KH Barmherzige Brüder, Klinik f. Onkologie und Hämatologie

Regensburg, Germany

Universitätsmedizin Rostock, Abt. f. Hämatologie und Onkologie, Klinik und Poliklinik für Innere Medizin

Rostock, Germany

Klinikum Stuttgart - Katharinenhospital, Klinik f. Hämatologie und Onkologie

Stuttgart, Germany

Robert-Bosch-Krankenhaus, Abt.f. Hämatologie und Onkologie

Stuttgart, Germany

Klinikum Traunstein, Hämatologie - Onkologie- Palliativmedizin

Traunstein, Germany

Klinikum Mutterhaus der Borromäerinnen gGmbH, Okologisches Zentrum

Trier, Germany

Universitätsklinikum Tübingen, Med Klinik I, Innere Medizin II

Tübingen, Germany

Universitätsklinikum Ulm, Klinik für Innere Medizin III

Ulm, Germany

Klinikum Wolfsburg, Med. Klinik II

Wolfsburg, Germany

Universitätsklinikum Würzburg, Med. Klinik u. Poliklinik II /ZIM

Würzburg, Germany

Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo, SC Ematologia

Alessandria, Italy

Policlinico S. Orsola Malpighi, Istituto di Ematologia e Oncologia Medica Seragnoli

Bologna, Italy

Comprensorio Sanitario di Bolzano, Ematologia e trapianto di midollo osseo

Bolzano, Italy

Spedali Civili, Struttura Complessa di Ematologia

Brescia, Italy

Ospedale Businco, UO Ematologia - CTMO

Cagliari, Italy

ASO S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo

Cuneo, Italy

AOU Policlinico Careggi, Unità Funzionale di Ematologia

Florence, Italy

IRCCS AOU S. Martino - IST, Clinica Ematologia

Genova, Italy

IRCCS AOU S. Martino - IST, Ematologia

Genova, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Ematologia

Meldola (FC), Italy

Istituto Scientifico San Raffaele, Unità Ricerca Clinica Linfomi

Milan, Italy

Ospedale Niguarda, Struttura Complessa di Ematologia

Milan, Italy

Università di Modena e Reggio Emilia Policlinico - COM Centro Oncologico Modenese, Dipartimento di Oncologia ed Ematologia

Modena, Italy

Ospedale S. Gerardo, Divisione di Ematologia

Monza, Italy

"IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale", Ematologia Oncologica

Naples, Italy

AOU Maggiore della Carità - Università del Piemonte Orientale, S.C.D.U Ematologia

Novara, Italy

AO Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia

Palermo, Italy

IRCCS Fondazione Policlinico San Matteo, Clinica Ematologia

Pavia, Italy

Azienda Ospedaliera Pisana Ospedale "S.Chiara", Dipartimento di Oncologia Divisione di Ematologia

Pisa, Italy

Ospedale S. Maria delle Croci, U.O di Ematologia

Ravenna, Italy

Azienda Ospedaliera Bianchi, Melacrino, Morelli, Divisione di Ematologia

Reggio Calabria, Italy

Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS, Ematologia

Reggio Emilia, Italy

Ospedale degli Infermi, U.O. Ematologia

Rimini, Italy

Policlinico Tor Vergata, UOC Oncoematologia

Roma, Italy

Università La Sapienza, Ematologia

Roma, Italy

Casa Sollievo della Sofferenza, U.O. Ematologia

San Giovanni Rotondo, Italy

A.O. Città della Salute e della Scienza, SC Ematologia

Torino, Italy

A.O. U. Città della Salute e della Scienza, S C Ematologia U

Torino, Italy

Ospedale Cà Foncello, U.O.C. Ematologia

Treviso, Italy

Ospedale Cardinale Panico, Divisione di Ematologia

Tricase, Italy

ASUI Integrata di Udine, Clinica Ematologia

Udine, Italy

Ospedale Policlinico G.B. Rossi, "Centro trapianto midollo osseo Ematologia"

Verona, Italy

Ospedale S. Bortolo, Ematologia

Vicenza, Italy

Haukeland University Hospital , Dept. of Oncology and Medical Physics

Bergen, Norway

Oslo University Hospital, Dept of Oncology

Oslo, Norway

Stavanger University Hospital, Division for Hematology&Oncology

Stavanger, Norway

UNN Tromsø, Oncology Dep

Tromsø, Norway

St. Olavs Hospital, Department of Oncology

Trondheim, Norway

Sahlgrenska University Hospital, Section of Hematology and Coagulation, Dept of internal medicine

Gothenburg, Sweden

University Hospital, Dept of Hematolgy

Linköping, Sweden

Sunderbyn Hospital, Dept of Medicine

Luleå, Sweden

Skane University Hospital

Lund, Sweden

Örebro University Hospital, Dept of Oncology

Örebro, Sweden

Karolinska University Hospital, Center of Hematology

Stockholm, Sweden

Norrland University Hospital, Dept of Oncology

Umeå, Sweden

Academic Hospital, Dept of Oncology

Uppsala, Sweden

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NCT02858258

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