AzTrials
AzTrials

Mantle Cell LymphomaPhase 3NCT02858258

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

A Phase 3 study testing R-CHOP/R-DHAP, Ibrutinib (Induction) and ASCT conditioning in people with Mantle Cell Lymphoma, run by Prof. Dr. M. Dreyling (co-chairman) at 112 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
R-CHOP/R-DHAP, Ibrutinib (Induction) and ASCT conditioning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
870 participants
Where
112 sitesin 5 countries
Study dates
Jul 2016to May 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must meet the following criteria:
  • Histologically confirmed diagnosis of MCL according to WHO classification
  • suitable for high-dose treatment including high-dose Ara-C
  • Stage II-IV (Ann Arbor)
  • Age ≥ 18 years and ≤ 65 years
  • Previously untreated MCL
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  • At least 1 measurable lesion; in case of bone marrow infiltration only, bone marrow aspiration and biopsy is mandatory for all staging evaluations.
  • ECOG/WHO performance status ≤ 2
  • The following laboratory values at screening (unless related to MCL):
  • Absolute neutrophil count (ANC) ≥1000 cells/µL
  • Platelets ≥100,000 cells/µL
  • Transaminases (AST and ALT) ≤3 x upper limit of normal (ULN)
  • Total bilirubin ≤2 x ULN unless due to known Morbus Meulengracht [Gilbert-Meulengracht-Syndrome])
  • Creatinine ≤2 mg/dL or calculated creatinine clearance ≥ 50 mL/min
  • Written informed consent form according to ICH/EU GCP and national regulations
  • Sexually active men and women of child-bearing potential must agree to use highly effective contraceptives (eg, condoms, implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or sterilized partner) while on study; this should be maintained for 90 days after the last dose of study drug.

Who cannot join

  • Any potential subject who meets any of the following criteria will be excluded from participating in the study.
  • Major surgery within 4 weeks prior to randomization.
  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg phenprocoumon).
  • History of stroke or intracranial hemorrhage within 6 months prior to randomization.
  • Requires treatment with strong CYP3A4/5 inhibitors.
  • Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
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  • Vaccinated with live, attenuated vaccines within 4 weeks prior to randomization.
  • Known CNS involvement of MCL
  • Clinically significant hypersensitivity (eg, anaphylactic or anaphylactoid reactions to the compound of ibrutinib itself or to the excipients in its formulation)
  • Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies
  • Previous lymphoma therapy with radiation, cytostatic drugs, anti-CD20 antibody or interferon except prephase therapy according to trial protocol
  • Serious concomitant disease interfering with a regular therapy according to the study protocol:
  • Cardiac (Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification or LVEF below LLN )
  • Pulmonary (e.g. chronic lung disease with hypoxemia)
  • Endocrinological (e.g. severe, not sufficiently controlled diabetes mellitus)
  • Renal insufficiency (unless caused by the lymphoma): creatinine > 2x normal value and/or creatinin clearance < 50 ml/min)
  • Impairment of liver function (unless caused by the lymphoma): transaminases > 3x normal or bilirubin > 2,0 mg/dl unless due to morbus Meulengracht (Gilbert-Meulengracht-Syndrome)
  • Patients with unresolved hepatitis B or C infection or known HIV positive infection (mandatory test)
  • Prior organ, bone marrow or peripheral blood stem cell transplantation
  • Concomitant or previous malignancies within the last 3 years other than basal cell skin cancer or in situ uterine cervix cancer
  • Pregnancy or lactation
  • Any psychological, familiar, sociological, or geographical condition potentially hampering compliance with the study protocol and follow up schedule
  • Subjects not able to give consent
  • Subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical trial
  • Participation in another clinical trial within 30 days before randomization in this study.

Trial locations and contacts

112 sites in 5 countries.

Döndü Gözel contact

+49 89 4400 ext. 77906

Doendue.Goezel@med.uni-muenchen.de

Christian Schmidt, Dr. contact

+49 89 4400 ext. 74900

Christian_Schmidt@med.uni-muenchen.de

112 sites in 5 countries

Germany60 sites, 60 recruiting

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

    Augsburg, 86156

    Christian Schmid, PD Dr.

    Andreas Rank, PD Dr.

    Recruiting

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

    Aurich, 26603

    Jan Janssen, Dr.

    Dietmar Reichert, Dr.

    Recruiting

  • Klinikum Bayreuth, Klinik f. Onkologie und Hämatologie

    Bayreuth, 95445

    Alexander Kiani, Prof.

    Armin Leitner, Dr.

    Recruiting

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

    Berlin, 10967

    Christian Scholz, PD Dr.

    Annette Dierig, Dr.

    Recruiting

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

    Berlin, 12200

    Antonio Pezzutto, Prof.

    Corinna Leng, Dr.

    Not yet recruiting

  • Helios Klinikum Berlin-Buch, Hämatologie, Onkologie und Tumorimmunologie

    Berlin, 13125

    Stephan Fuhrmann, Dr.

    Recruiting

  • Knappschaftskrankenhaus Bochum-Langendreer

    Bochum, 44892

    Wolff Schmiegel, Prof. Dr.

    Recruiting

  • Universitätsklinikum Bonn

    Bonn, 53127

    Matthias Zipfel, Dr.

    Johannes Heiders, Dr.

    Recruiting

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

    Bremen, 28239

    Ralf U. Trappe, Prof.

    Christoph Diekmann, Dr.

    Recruiting

  • Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin II

    Chemnitz, 09113

    Mathias Hänel, PD Dr.

    Andreas Thiel

    Recruiting

  • Uniklinik Köln, Klinik I für Innere Medizin

    Cologne, 50937

    Kai Hübel, Prof.

    Peter Borchmann, Prof.

    Recruiting

  • DONAUISAR Klinikum Deggendorf, Innere Medizin II

    Deggendorf, 94469

    Nicolas Graf, PD Dr.

    Regine Maier

    Recruiting

  • St.-Johannes-Hospital

    Dortmund, 44137

    Ralf G. Meyer, PD Dr.

    Heidrun Hindahl, Dr.

    Recruiting

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

    Dresden, 01307

    Gabriele Prange-Krex, Dr.

    Johannes Mohm, Dr.

    Recruiting

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

    Dresden, 01307

    Frank Kroschinsky, Prof. Dr.

    Rainer Ordemann, Prof. Dr.

    Recruiting

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

    Düsseldorf, 40225

    Guido Kobbe, Prof.

    Mustafa Kondakci, Dr.

    Recruiting

  • Marien Hospital Düsseldorf

    Düsseldorf, 40479

    Aristoteles Giagounidis, Prof. Dr.

    Maika Klaiber-Hakimi, Dr.

    Recruiting

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

    Erfurt, 99089

    Herbert G. Sayer, PD Dr.

    Volker Schmidt, Dr.

    Recruiting

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

    Erlangen, 91054

    Bernd Spriewald, Prof. Dr.

    Stefan Krause, Prof. Dr.

    Recruiting

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

    Eschweiler, 52249

    Peter Staib, PD Dr.

    Frank Schlegel, Dr.

    Recruiting

  • Universitätsklinikum Essen, Klinik f. Hämatologie

    Essen, 45147

    Jan Dürig, Prof.

    Alexander Carpinteiro, Dr.

    Recruiting

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

    Freiburg im Breisgau, 79106

    Reinhard Marks, PD Dr.

    Anna-Lena Illert, Dr.

    Recruiting

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

    Göttingen, 37075

    Wolfram Jung, Dr.

    Justin Hasenkamp, Dr.

    Recruiting

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

    Greifswald, 17475

    Christian Schmidt, Prof.

    William Krüger, Prof.

    Recruiting

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

    Hagen, 58095

    Hans-Walter Lindemann, Dr.

    Cordula Maciejewski

    Recruiting

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

    Hamburg, 20246

    Judith Dierlamm, Prof.

    Lars Arne Berger, Dr.

    Recruiting

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

    Hamburg, 22763

    Hans-Jürgen Salwender, Dr.

    Murwan Ayoub, Dr.

    Recruiting

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

    Heidelberg, 69120

    Mathias Witzens-Harig, Prof.

    Patrick Wuchter, Dr.

    Recruiting

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

    Homburg, 66421

    Michael Pfreundschuh, Prof.

    Jörg Bittenbring, Dr.

    Recruiting

  • Klinikum Idar-Oberstein GmbH, Medizinische Klinik I

    Idar-Oberstein, 55743

    Eva Roemer, Dr.

    Marina Bischoff, Dr.

    Recruiting

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

    Jena, 07747

    Sebastian Scholl, PD Dr.

    Thomas Ernst, PD Dr.

    Recruiting

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

    Karlsruhe, 76133

    Martin Bentz, Prof.

    Joy Dickinson, Dr.

    Recruiting

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

    Kiel, 24105

    Christiane Pott, Prof. Dr.

    Michael Kneba, Prof. Dr.

    Recruiting

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

    Koblenz, 56068

    Dirk Niemann, Dr.

    Ralph Naumann, Prof.

    Recruiting

  • Praxisklinik f. Hämatologie und Onkologie Koblenz

    Koblenz, 56068

    Jörg Thomalla, Dr.

    Christoph von Roye, Dr.

    Recruiting

  • Onkologisch-Hämatologische Praxis Dr. Vehling-Kaiser

    Landshut, 84028

    Ursula Vehling-Kaiser, Dr.

    Mike Haberkorn

    Recruiting

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

    Landshut, 84034

    Barbara Kempf

    Heiko Merkle, Dr.

    Recruiting

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

    Lebach, 66822

    Stephan Kremers, Dr.

    Stefan Bauer, PD Dr.

    Recruiting

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

    Leipzig, 04103

    Dietger Niederwieser, Prof.

    Gerhard Behre, Prof. Dr.

    Recruiting

  • Klinikum Lippe GmbH, Onkologie und Hämatologie

    Lemgo, 32657

    Frank Hartmann, Prof. Dr.

    Tanja Hesse, Dr.

    Recruiting

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

    Ludwigshafen, 67063

    Martin Hoffmann, Dr.

    Michael Uppenkamp, Prof.

    Recruiting

  • Universitätsklinikum Magdeburg AöR, Klinik f. Hämatologie und Onkologie

    Magdeburg, 39120

    Enrico Schalk, Dr.

    Christian Krogel, Dr.

    Recruiting

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

    Mainz, 55131

    Georg Heß, PD Dr.

    Hans-Joachim Beck, Dr.

    Recruiting

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

    Minden, 32429

    Hans-Heinrich Wöltjen, Dr.

    Kai Wille, Dr.

    Recruiting

  • Klinikum der Universität München, Med. Klinik und Poliklinik III

    München, 81377

    Christian Schmidt, Dr., Christian_Schmidt@med.uni-muenchen.de

    Martin Dreyling, Prof.

    Recruiting

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

    München, 81675

    Ulrich Keller, Prof.

    Christian Bogner, Dr.

    Recruiting

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

    Münster, 48149

    Georg Lenz, Prof.

    Christoph Schliemann, PD Dr.

    Recruiting

  • Klinikum Nürnberg,5. Medizinische Klinik, Onkologie / Hämatologie

    Nuremberg, 90419

    Kerstin Schäfer-Eckart, Dr.

    Knut Wendelin, Dr.

    Recruiting

  • Klinikum Oldenburg gGmbH, Med. Klinik II

    Oldenburg, 26133

    Bernd Metzner, PD Dr.

    Ruth Thole, Dr.

    Recruiting

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

    Potsdam, 14467

    Georg Maschmeyer-Krull, Prof.

    Frank Breywisch, Dr,

    Recruiting

  • KH Barmherzige Brüder, Klinik f. Onkologie und Hämatologie

    Regensburg, 93049

    Bernhard Heilmeier, Dr.

    Anke Schlenska-Lange, Dr.

    Recruiting

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

    Rostock, 18057

    Christian Junghanß, Prof.

    Christina Große-Thie, Dr.

    Recruiting

  • Klinikum Stuttgart - Katharinenhospital, Klinik f. Hämatologie und Onkologie

    Stuttgart, 70174

    Gerald Illerhaus, Prof.

    Dennis Hahn, Dr.

    Recruiting

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

    Stuttgart, 70376

    Matthias Vöhringer, Dr.

    Sonja Martin, Dr.

    Recruiting

  • Klinikum Traunstein, Hämatologie - Onkologie- Palliativmedizin

    Traunstein, 83278

    Thomas W. Kubin, Dr.

    Florian Zettl, Dr.

    Recruiting

  • Klinikum Mutterhaus der Borromäerinnen gGmbH, Okologisches Zentrum

    Trier, 54290

    Rolf Mahlberg, Dr.

    Stefan Heidel, Dr.

    Recruiting

  • Universitätsklinikum Tübingen, Med Klinik I, Innere Medizin II

    Tübingen, 72026

    Martin Sökler, Dr.

    Martin Müller, PD Dr.

    Recruiting

  • Universitätsklinikum Ulm, Klinik für Innere Medizin III

    Ulm, 89081

    Stephan Stilgenbauer, Prof.

    Johannes Bloehdorn, Dr.

    Recruiting

  • Klinikum Wolfsburg, Med. Klinik II

    Wolfsburg, 38440

    Steffen Neumann, Dr.

    Nils Homann, Prof.

    Recruiting

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

    Würzburg, 97080

    Max S. Topp, Prof.

    Johannes Düll, Dr.

    Not yet recruiting

Other trials in Germany

Italy33 sites, 33 recruiting

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

    Alessandria, 15121

    Marco Ladetto, Dr.

    Manuela Zanni, Dr.

    Recruiting

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

    Bologna, 40138

    Vittorio Stefoni, Dr.

    Not yet recruiting

  • Comprensorio Sanitario di Bolzano, Ematologia e trapianto di midollo osseo

    Bolzano, 39100

    Michael Mian, Dr.

    Not yet recruiting

  • Spedali Civili, Struttura Complessa di Ematologia

    Brescia, 25123

    Alessandro Re, Dr.

    Not yet recruiting

  • Ospedale Businco, UO Ematologia - CTMO

    Cagliari, 09121

    Maria Giuseppina Cabras, Dr.

    Not yet recruiting

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

    Cuneo, 12100

    Claudia Castellino, Dr.

    Not yet recruiting

  • AOU Policlinico Careggi, Unità Funzionale di Ematologia

    Florence, 50134

    Luigi Rigacci, Dr.

    Not yet recruiting

  • IRCCS AOU S. Martino - IST, Clinica Ematologia

    Genova, 16132

    Marco Gobbi, Prof.

    Not yet recruiting

  • IRCCS AOU S. Martino - IST, Ematologia

    Genova, 16132

    Angela Congiu, Dr.

    Not yet recruiting

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

    Meldola (FC), 47014

    Gerardo Musuraca, Dr.

    Not yet recruiting

  • Istituto Scientifico San Raffaele, Unità Ricerca Clinica Linfomi

    Milan, 20132

    Andres Ferreri, Dr.

    Not yet recruiting

  • Ospedale Niguarda, Struttura Complessa di Ematologia

    Milan, 20162

    Chiara Rusconi, Dr.

    Not yet recruiting

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

    Modena, 41124

    Franco Narni, Prof.

    Not yet recruiting

  • Ospedale S. Gerardo, Divisione di Ematologia

    Monza, 20052

    Silvia Bolis, Dr.

    Not yet recruiting

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

    Naples, 80131

    Antonello Pinto, Dr.

    Recruiting

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

    Novara, 28100

    Gianluca Gaidano, Prof.

    Not yet recruiting

  • AO Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia

    Palermo, 90146

    Caterina Patti, Dr.

    Not yet recruiting

  • IRCCS Fondazione Policlinico San Matteo, Clinica Ematologia

    Pavia, 27100

    Luca Arcaini, Prof.

    Not yet recruiting

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

    Pisa, 56126

    Mario Petrini, Prof.

    Not yet recruiting

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

    Ravenna, 48121

    Monica Tani, Dr.

    Not yet recruiting

  • Azienda Ospedaliera Bianchi, Melacrino, Morelli, Divisione di Ematologia

    Reggio Calabria, 89125

    Caterina Stelitano, Dr.

    Not yet recruiting

  • Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS, Ematologia

    Reggio Emilia, 42123

    Francesco Merli, Dr.

    Not yet recruiting

  • Ospedale degli Infermi, U.O. Ematologia

    Rimini, 47923

    Annalia Molinari, Dr.

    Not yet recruiting

  • Policlinico Tor Vergata, UOC Oncoematologia

    Roma, 00133

    Maria Cantonetti, Prof

    Not yet recruiting

  • Università La Sapienza, Ematologia

    Roma, 00161

    Maurizio Martelli, Prof.

    Not yet recruiting

  • Casa Sollievo della Sofferenza, U.O. Ematologia

    San Giovanni Rotondo, 71013

    Nicola Cascavilla, Dr.

    Not yet recruiting

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

    Torino, 10126

    Umberto Vitolo, Dr.

    Not yet recruiting

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

    Torino, 10126

    Federica Cavallo, Dr.

    Not yet recruiting

  • Ospedale Cà Foncello, U.O.C. Ematologia

    Treviso, 31100

    Piero Maria Stefani, Dr.

    Not yet recruiting

  • Ospedale Cardinale Panico, Divisione di Ematologia

    Tricase, 73054

    Vincenzo Pavone, Dr.

    Not yet recruiting

  • ASUI Integrata di Udine, Clinica Ematologia

    Udine, 33100

    Francesco Zaja, Prof.

    Not yet recruiting

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

    Verona, 37134

    Fabio Benedetti, Dr.

    Recruiting

  • Ospedale S. Bortolo, Ematologia

    Vicenza, 36100

    Carlo Visco, Dr.

    Maria Chiara Tisi, Dr.

    Recruiting

Other trials in Italy

Sweden8 sites, 8 recruiting

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

    Gothenburg, 413 45

    Catharina Lewerin

    Not yet recruiting

  • University Hospital, Dept of Hematolgy

    Linköping, 581 85

    Ingemar Lagerlöf, Dr.

    Ronald Svensson, Dr.

    Recruiting

  • Sunderbyn Hospital, Dept of Medicine

    Luleå, 971 80

    Lena Brandefors, Dr.

    Not yet recruiting

  • Skane University Hospital

    Lund, 221 85

    Mats Jerkeman, MD

    Mats Jerkeman, MD

    Recruiting

  • Örebro University Hospital, Dept of Oncology

    Örebro, 701 85

    Karin Nyström, Dr.

    David Löfgren

    Recruiting

  • Karolinska University Hospital, Center of Hematology

    Stockholm, 141 86

    Kristina Sonnevi, Dr.

    Torsten Dahlen, Dr.

    Recruiting

  • Norrland University Hospital, Dept of Oncology

    Umeå, 901 85

    Karin Papworth

    Sara Sjöström, Dr.

    Not yet recruiting

  • Academic Hospital, Dept of Oncology

    Uppsala, 751 85

    Anna Laurell, Dr.

    Ingrid Glimelius, Dr.

    Recruiting

Other trials in Sweden

Denmark6 sites, 6 recruiting

  • Aalborg University Hospital, Dept of Hematology

    Aalborg, 9000

    Herdis Larsen, Dr.

    Not yet recruiting

  • Aarhus University Hospital, Dept of Hematology

    Aarhus C, 8000

    Hans Bentzen, Dr.

    Not yet recruiting

  • Rigshospitalet, Clinic of Hematology

    Copenhagen, 2100

    Martin Hutchings, Dr.

    Not yet recruiting

  • Herlev Hospital, Department of Hematology L121

    Herlev, 2730

    Pär Lars Josefsson

    Danny Stoltenberg

    Not yet recruiting

  • Odense University Hospital, Dept of Hematology X

    Odense C, 5000

    Jacob Haaber Christensen, Dr.

    Not yet recruiting

  • Sjaelland University Hospital, Dept of Hematology

    Roskilde, 4000

    Christian Bjorn Poulsen, Dr.

    Not yet recruiting

Other trials in Denmark

Norway5 sites, 5 recruiting

  • Haukeland University Hospital , Dept. of Oncology and Medical Physics

    Bergen, 5021

    Anne Turid Bjørnevik, Dr.

    Not yet recruiting

  • Oslo University Hospital, Dept of Oncology

    Oslo, 0310

    Arne Kolstad, Dr.

    Not yet recruiting

  • Stavanger University Hospital, Division for Hematology&Oncology

    Stavanger, 4011

    Peter Meyer, Dr.

    Not yet recruiting

  • UNN Tromsø, Oncology Dep

    Tromsø, 9038

    Fredrik Sund

    Not yet recruiting

  • St. Olavs Hospital, Department of Oncology

    Trondheim, 7006

    Karin Inger Martina Fahl Wader, MD Phd.

    Not yet recruiting

Other trials in Norway

About this study

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

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.

Read the detailed description

Objectives and Endpoints

Primary Objective:

To establish one of three study arms, R-CHOP/R-DHAP followed by ASCT (control arm A), R-CHOP+ibrutinib /R-DHAP followed by ASCT and ibrutinib maintenance experimental arm A+I), and R-CHOP+ibrutinib /R-DHAP followed by ibrutinib maintenance experimental arm I) as future standard based on the comparison of the investigator-assessed failure-free survival (FFS).

Secondary Objectives:

  • To compare the efficacy of the three treatment arms in terms of secondary efficacy endpoints
  • To determine the safety and tolerability of ibrutinib during induction immuno-chemotherapy and during maintenance and to compare the safety profile of the three treatment arms in terms of secondary toxicity endpoints

Primary Endpoint:

FFS defined as time from start of treatment to stable disease at end of immuno-chemotherapy, progressive disease, or death from any cause.

Secondary Efficacy Endpoints:

  • Overall survival (OS)
  • Progression-free survival (PFS) from randomization, from end of induction immuno-chemotherapy in patients with CR or PR at end of induction immuno-chemotherapy, and from the staging 6 weeks after end of induction assessment (at month 6)
  • Overall response and complete remission rates at midterm, at end of induction, 3 months after end of induction immunochemotherapy (at month 6)
  • PR to CR conversion rate during follow-up after end of induction immuno-chemotherapy

Secondary Toxicity Endpoints:

  • Rates of AEs, SAEs, and SUSARs by CTC grade (Version 4.03) during induction immuno-chemotherapy and during periods of follow-up after response to immune-chemotherapy
  • Cumulative incidence rates of SPMs

Exploratory Objectives:

  • To compare feasibility of ASCT in arm A+I vs. arm A
  • To compare minimal residual disease status between the three treatment groups
  • To determine the impact of ibrutinib during induction immuno-chemotherapy and during maintenance therapy on the minimal residual disease status
  • To determine the prognostic value of minimal residual disease status
  • To determine the prognostic value of positron emission tomography with fluorine 18-fluorodeoxyglucose
  • To determine clinical and biological prognostic and predictive factors
  • To determine the role of total body irradiation (TBI) in ASCT conditioning

Exploratory Endpoints:

  • Rate of successful stem cell mobilisations (success: separation of at least 2x2x10(6) CD34-positive cells, including a back-up)
  • Rate of molecular remissions (MRD-negative patients) at midterm, at end of induction immuno-chemotherapy, and at staging time-points during follow-up in patients with remission after end of induction immuno-chemotherapy
  • Time to molecular remission from start of therapy
  • Time to molecular relapse for patients in clinical and molecular remission after end of induction immunochemotherapy
  • RD in FDG-PET negative or positive patients after induction and ASCT

Exploratory objectives may be evaluated only in a subset of patients according to local standards and resources.

Being tested
R-CHOP/R-DHAP, Ibrutinib (Induction), ASCT conditioning, Ibrutinib (Maintenance)
Keywords
MCL
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • R-CHOP/R-DHAPDrug

    Also called rituximab, CHOP, DHAP

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

  • Ibrutinib (Induction)Drug

    Also called Imbruvica

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

  • ASCT conditioningDrug

    Also called THAM or BEAM

    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)

  • Ibrutinib (Maintenance)Drug

    Also called Imbruvica

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

Study groups in NCT02858258
Study groupRoleWhat they receive
Standard Arm AActive comparatorR-CHOP/R-DHAP: Alternating 3 cycles of R-CHOP in cycle 1,3,5 and 3 cyles of R-DHAP in cycle 2,4,6; each 21 day cycle Drug: R-CHOP/R-DHAP ASCT conditioning (ASCT: autologous stemm cell transplantation) Drug: THAM or BEAM
Receives: Drug: R-CHOP/R-DHAP; Drug: ASCT conditioning
Experimental Arm A+IExperimentalR-CHOP+Ibrutinib/R-DHAP: Alternating 3 cycles of R-CHOP + Ibrutinib at Days 1-19 in cycle 1,3,5 and 3 cyles of R-DHAP in cycle 2,4,6; each 21 day cycle Drug: R-CHOP/R-DHAP Drug: Ibrutinib (Induction) ASCT conditioning (ASCT: autologous stemm cell transplantation) Drug: THAM or BEAM 2 years Ibrutinib Maintenance Drug: Ibrutinib (Maintenace)
Receives: Drug: R-CHOP/R-DHAP; Drug: Ibrutinib (Induction); Drug: ASCT conditioning; Drug: Ibrutinib (Maintenance)
Experimental Arm IExperimentalR-CHOP+Ibrutinib / R-DHAP: Alternating 3 cycles of R-CHOP + Ibrutinib at Days1-19 in cycle 1,3,5 and 3 cyles of R-DHAP in cycle 2,4,6; each 21 day cycle Drug: R-CHOP/R-DHAP Drug: Ibrutinib (Induction) 2 years Ibrutinib Maintenance Drug: Ibrutinib (Maintenance)
Receives: Drug: R-CHOP/R-DHAP; Drug: Ibrutinib (Induction); Drug: Ibrutinib (Maintenance)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Failure Free Survival

    Measured: From start of treatment until stable disease at end of immuno-chemotherapy, progressive disease, or death from any cause, whichever comes first, assessed up to 120 months.

Secondary outcomes (5)

  1. Overall Survival

    Measured: From start of treatment until the date of first documented progression, assessed up to 120 months.

  2. Number of participants with treatment-related adverse events as assessed by CTC Version 4.03

    Safety and tolerability

    Measured: From start of Ibrutinib treatment during induction immuno-chemotherapy and during maintenance and to compare the safety profile of the three treatment arms in terms of secondary toxicity endpoints. Through study conduction, an average of up to 30 months.

  3. Progression-free survival (PFS)

    Measured: PFS is the time to progression or death from any cause. Assed up to 120 months.

  4. Number of Secondary Primary Malignancies

    Toxicity Endpoints

    Measured: From start of treatment through the study conduction, up to 120 months.

  5. Number of Adverse Events by CTC grade (Version 4.03)

    Toxicity Endpoints

    Measured: From start of treatment through the study conduction, up to 120 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionMay 2021 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
870 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02858258
Sponsor's protocol ID
TRIANGLE
Status last verified
Dec 2017
First submitted
14 Jul 2016
Last updated
19 Dec 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Dreyling M, Doorduijn J, Gine E, Jerkeman M, Walewski J, Hutchings M, Mey U, Riise J, Trneny M, Vergote VKJ, Shpilberg O, da Silva MG, Leppa S, Jiang L, Stilgenbauer S, Kerkhoff A, Jachimowicz RD, Hess G, Meerten TV, Wirths S, Herhaus P, Novak U, Dierlamm J, Hanel M, Hanoun C, Sonnevi K, Visco C, Donnarumma D, Ferreri AJM, Patti C, Stefani PM, Pott C, Klapper W, Schmidt C, Unterhalt M, Tix T, Ladetto M, Hoster E; European Mantle Cell Lymphoma Network. Addition of autologous stem-cell transplantation to an ibrutinib-containing first-line treatment in patients aged 18-65 years with mantle cell lymphoma (TRIANGLE): 4.5-year follow-up of a three-arm, randomised, open-label, phase 3 superiority trial of the European MCL Network. Lancet. 2026 May 16;407(10542):1953-1967. doi: 10.1016/S0140-6736(26)00362-4.

    PubMed 42134356

  • Dreyling M, Doorduijn J, Gine E, Jerkeman M, Walewski J, Hutchings M, Mey U, Riise J, Trneny M, Vergote V, Shpilberg O, Gomes da Silva M, Leppa S, Jiang L, Stilgenbauer S, Kerkhoff A, Jachimowicz RD, Celli M, Hess G, Arcaini L, Visco C, van Meerten T, Wirths S, Zinzani PL, Novak U, Herhaus P, Benedetti F, Sonnevi K, Hanoun C, Hanel M, Dierlamm J, Pott C, Klapper W, Gozel D, Schmidt C, Unterhalt M, Ladetto M, Hoster E. Ibrutinib combined with immunochemotherapy with or without autologous stem-cell transplantation versus immunochemotherapy and autologous stem-cell transplantation in previously untreated patients with mantle cell lymphoma (TRIANGLE): a three-arm, randomised, open-label, phase 3 superiority trial of the European Mantle Cell Lymphoma Network. Lancet. 2024 May 25;403(10441):2293-2306. doi: 10.1016/S0140-6736(24)00184-3. Epub 2024 May 2.

    PubMed 38705160

  • Kumar A. What is the role of up-front autologous stem cell transplantation in mantle cell lymphoma? Hematology Am Soc Hematol Educ Program. 2022 Dec 9;2022(1):155-162. doi: 10.1182/hematology.2022000333.

    PubMed 36485104

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing R-CHOP/R-DHAP, Ibrutinib (Induction) and ASCT conditioning in people with Mantle Cell Lymphoma, run by Prof. Dr. M. Dreyling (co-chairman) at 112 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in Germany, Italy, Sweden, Denmark, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Döndü Gözel (+49 89 4400 ext. 77906, Doendue.Goezel@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Failure Free Survival (time frame: From start of treatment until stable disease at end of immuno-chemotherapy, progressive disease, or death from any cause, whichever comes first, assessed up to 120 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02858258, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.

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