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

Who is this study for? Patients with Mantle Cell Lymphoma
Status: Recruiting
Location: See all (112) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

∙ 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

• 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.

Locations
Other Locations
Denmark
Aalborg University Hospital, Dept of Hematology
NOT_YET_RECRUITING
Aalborg
Aarhus University Hospital, Dept of Hematology
NOT_YET_RECRUITING
Aarhus C
Rigshospitalet, Clinic of Hematology
NOT_YET_RECRUITING
Copenhagen
Herlev Hospital, Department of Hematology L121
NOT_YET_RECRUITING
Herlev
Odense University Hospital, Dept of Hematology X
NOT_YET_RECRUITING
Odense C
Sjaelland University Hospital, Dept of Hematology
NOT_YET_RECRUITING
Roskilde
Germany
Zentralklinik Augsburg, II. Med. Klinik, Hämatologie int. Onkologie
RECRUITING
Augsburg
Onkologische Gemeinschaftspraxis Dr. Janssen/Dr. Reichert in der Ubbo-Emmius-Klinik
RECRUITING
Aurich
Klinikum Bayreuth, Klinik f. Onkologie und Hämatologie
RECRUITING
Bayreuth
Charité Univ.-Medizin Berlin, Med. Klinik - Hämatologie, Onkologie und Tumorimmunologie
NOT_YET_RECRUITING
Berlin
Helios Klinikum Berlin-Buch, Hämatologie, Onkologie und Tumorimmunologie
RECRUITING
Berlin
Vivantes Klinikum Am Urban, Klinik f. Innere Medizin, Hämatologie und Onkologie
RECRUITING
Berlin
Knappschaftskrankenhaus Bochum-Langendreer
RECRUITING
Bochum
Universitätsklinikum Bonn
RECRUITING
Bonn
Diako ev. Diakonie-KH gGmbH, Med. Klinik II, Hämatologie und Onkologie
RECRUITING
Bremen
Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin II
RECRUITING
Chemnitz
Uniklinik Köln, Klinik I für Innere Medizin
RECRUITING
Cologne
DONAUISAR Klinikum Deggendorf, Innere Medizin II
RECRUITING
Deggendorf
St.-Johannes-Hospital
RECRUITING
Dortmund
Gemeinschaftspraxis Dr. Mohm und Prange-Krex - Fachärzte für Innere Medizin und Hämatologie und Onkologie
RECRUITING
Dresden
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
RECRUITING
Dresden
Marien Hospital Düsseldorf
RECRUITING
Düsseldorf
Universitätsklinikum Düsseldorf, Klinik f. Hämatologie, Onkologie und klinische Immunologie
RECRUITING
Düsseldorf
Helios Klinikum Erfurt GmbH, Zentrum f. Innere Medizin u. internistische Onkologie, Hämostaseologie
RECRUITING
Erfurt
Universitätsklinikum Erlangen, Med. Klinik 5, Hämatologie und internistische Onkologie
RECRUITING
Erlangen
St.-Antonius-Hospital Eschweiler, Klinik für Hämatologie und Onkologie
RECRUITING
Eschweiler
Universitätsklinikum Essen, Klinik f. Hämatologie
RECRUITING
Essen
Universitätsklinikum Freiburg, Klinik f. Innere Medizin, Hämatologie, Onkologie u. Stammzelltransplantation
RECRUITING
Freiburg Im Breisgau
Universitätsmedizin Göttingen, Zentrum f. Innere Medizin, Klinik f. Hämatologie und Medizinische Onkologie
RECRUITING
Göttingen
Universitätsmedizin Greifswald, Klinik u. Poliklinik f. Innere Medizin C, Hämatologie u. Onkologie-, Transplantationszentrum
RECRUITING
Greifswald
Katholisches Krankenhaus Hagen gGmbH, St.-Marien-Hospital, Klinik f. Hämatologie und Onkologie
RECRUITING
Hagen
Asklepios Klinik Altona, II. Med.Abt. f. Hämatologie und internistische Onkologie, Stammzelltransplantation
RECRUITING
Hamburg
Universitätsklinikum Hamburg-Eppendorf (UKE), II. Med. Klinik u. Poliklinik, Onkologie, Hämatologie, KMT
RECRUITING
Hamburg
Universitätsklinikum Heidelberg, Med. Klinik - Innere Medizin V - Hämatologie, Onkologie und Rheumatologie
RECRUITING
Heidelberg
Universitätsklinikum des Saarlandes, Klinik f. Innere Medizin I Hämatologie & Onkologie
RECRUITING
Homburg
Klinikum Idar-Oberstein GmbH, Medizinische Klinik I
RECRUITING
Idar-oberstein
Universitätsmedizin Jena, Klinik f. Innere Medizin II, Abteilung Hämatologie u. Internistische Onkologie
RECRUITING
Jena
Städtisches Klinikum Karlsruhe, Med. Klinik III, Hämatologie und Onkologie
RECRUITING
Karlsruhe
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik f. Innere Medizin II - Hämatologie und Onkologie
RECRUITING
Kiel
Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin, Klinik f. Innere Medizin
RECRUITING
Koblenz
Praxisklinik f. Hämatologie und Onkologie Koblenz
RECRUITING
Koblenz
Klinikum Landshut gGmbH, Med. Klinik III, Hämatologie/Internistische Onkologie
RECRUITING
Landshut
Onkologisch-Hämatologische Praxis Dr. Vehling-Kaiser
RECRUITING
Landshut
Caritas-KHLebach, Gemeinschaftspraxis f. Hämatologie und Onkologie, Onkologisches Zentrum Lebach
RECRUITING
Lebach
Universitätsklinikum Leipzig AöR, selbständige Abteilung f. Hämatologie und Internistische Onkologie, Hämostaseologische Ambulanz
RECRUITING
Leipzig
Klinikum Lippe GmbH, Onkologie und Hämatologie
RECRUITING
Lemgo
Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Med. Klinik A
RECRUITING
Ludwigshafen
Universitätsklinikum Magdeburg AöR, Klinik f. Hämatologie und Onkologie
RECRUITING
Magdeburg
Universitätsmedizin der Univ. Mainz, III. Med. Klinik u. Poliklinik
RECRUITING
Mainz
Johannes Wiesling Klinikum Minden, Klinik f. Hämatologie/Onkologie, Hämostaseologie und Palliativmedizin
RECRUITING
Minden
Klinikum der Universität München, Med. Klinik und Poliklinik III
RECRUITING
München
Klinikum Rechts der Isar, III. Med. Klinik - Hämatologie und Onkologie
RECRUITING
München
Universitätsklinikum Münster, Med. Klinik A, Translationale Onkologie / Lymphome
RECRUITING
Münster
Klinikum Nürnberg,5. Medizinische Klinik, Onkologie / Hämatologie
RECRUITING
Nuremberg
Klinikum Oldenburg gGmbH, Med. Klinik II
RECRUITING
Oldenburg
Klinikum Ernst von Bergmann Potsdam gGmbH, Zentrum f. Innere Medizin, Klinik f. Hämatologie und Onkologie
RECRUITING
Potsdam
KH Barmherzige Brüder, Klinik f. Onkologie und Hämatologie
RECRUITING
Regensburg
Universitätsmedizin Rostock, Abt. f. Hämatologie und Onkologie, Klinik und Poliklinik für Innere Medizin
RECRUITING
Rostock
Klinikum Stuttgart - Katharinenhospital, Klinik f. Hämatologie und Onkologie
RECRUITING
Stuttgart
Robert-Bosch-Krankenhaus, Abt.f. Hämatologie und Onkologie
RECRUITING
Stuttgart
Klinikum Traunstein, Hämatologie - Onkologie- Palliativmedizin
RECRUITING
Traunstein
Klinikum Mutterhaus der Borromäerinnen gGmbH, Okologisches Zentrum
RECRUITING
Trier
Universitätsklinikum Tübingen, Med Klinik I, Innere Medizin II
RECRUITING
Tübingen
Universitätsklinikum Ulm, Klinik für Innere Medizin III
RECRUITING
Ulm
Klinikum Wolfsburg, Med. Klinik II
RECRUITING
Wolfsburg
Universitätsklinikum Würzburg, Med. Klinik u. Poliklinik II /ZIM
NOT_YET_RECRUITING
Würzburg
Italy
Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo, SC Ematologia
RECRUITING
Alessandria
Policlinico S. Orsola Malpighi, Istituto di Ematologia e Oncologia Medica Seragnoli
NOT_YET_RECRUITING
Bologna
Comprensorio Sanitario di Bolzano, Ematologia e trapianto di midollo osseo
NOT_YET_RECRUITING
Bolzano
Spedali Civili, Struttura Complessa di Ematologia
NOT_YET_RECRUITING
Brescia
Ospedale Businco, UO Ematologia - CTMO
NOT_YET_RECRUITING
Cagliari
ASO S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo
NOT_YET_RECRUITING
Cuneo
AOU Policlinico Careggi, Unità Funzionale di Ematologia
NOT_YET_RECRUITING
Florence
IRCCS AOU S. Martino - IST, Clinica Ematologia
NOT_YET_RECRUITING
Genova
IRCCS AOU S. Martino - IST, Ematologia
NOT_YET_RECRUITING
Genova
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Ematologia
NOT_YET_RECRUITING
Meldola (fc)
Istituto Scientifico San Raffaele, Unità Ricerca Clinica Linfomi
NOT_YET_RECRUITING
Milan
Ospedale Niguarda, Struttura Complessa di Ematologia
NOT_YET_RECRUITING
Milan
Università di Modena e Reggio Emilia Policlinico - COM Centro Oncologico Modenese, Dipartimento di Oncologia ed Ematologia
NOT_YET_RECRUITING
Modena
Ospedale S. Gerardo, Divisione di Ematologia
NOT_YET_RECRUITING
Monza
IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale, Ematologia Oncologica
RECRUITING
Napoli
AOU Maggiore della Carità - Università del Piemonte Orientale, S.C.D.U Ematologia
NOT_YET_RECRUITING
Novara
AO Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia
NOT_YET_RECRUITING
Palermo
IRCCS Fondazione Policlinico San Matteo, Clinica Ematologia
NOT_YET_RECRUITING
Pavia
Azienda Ospedaliera Pisana Ospedale S.Chiara, Dipartimento di Oncologia Divisione di Ematologia
NOT_YET_RECRUITING
Pisa
Ospedale S. Maria delle Croci, U.O di Ematologia
NOT_YET_RECRUITING
Ravenna
Azienda Ospedaliera Bianchi, Melacrino, Morelli, Divisione di Ematologia
NOT_YET_RECRUITING
Reggio Calabria
Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS, Ematologia
NOT_YET_RECRUITING
Reggio Emilia
Ospedale degli Infermi, U.O. Ematologia
NOT_YET_RECRUITING
Rimini
Policlinico Tor Vergata, UOC Oncoematologia
NOT_YET_RECRUITING
Roma
Università La Sapienza, Ematologia
NOT_YET_RECRUITING
Roma
Casa Sollievo della Sofferenza, U.O. Ematologia
NOT_YET_RECRUITING
San Giovanni Rotondo
A.O. Città della Salute e della Scienza, SC Ematologia
NOT_YET_RECRUITING
Torino
A.O. U. Città della Salute e della Scienza, S C Ematologia U
NOT_YET_RECRUITING
Torino
Ospedale Cà Foncello, U.O.C. Ematologia
NOT_YET_RECRUITING
Treviso
Ospedale Cardinale Panico, Divisione di Ematologia
NOT_YET_RECRUITING
Tricase
ASUI Integrata di Udine, Clinica Ematologia
NOT_YET_RECRUITING
Udine
Ospedale Policlinico G.B. Rossi, Centro trapianto midollo osseo Ematologia
RECRUITING
Verona
Ospedale S. Bortolo, Ematologia
RECRUITING
Vicenza
Norway
Haukeland University Hospital , Dept. of Oncology and Medical Physics
NOT_YET_RECRUITING
Bergen
Oslo University Hospital, Dept of Oncology
NOT_YET_RECRUITING
Oslo
Stavanger University Hospital, Division for Hematology&Oncology
NOT_YET_RECRUITING
Stavanger
UNN Tromsø, Oncology Dep
NOT_YET_RECRUITING
Tromsø
St. Olavs Hospital, Department of Oncology
NOT_YET_RECRUITING
Trondheim
Sweden
Sahlgrenska University Hospital, Section of Hematology and Coagulation, Dept of internal medicine
NOT_YET_RECRUITING
Gothenburg
University Hospital, Dept of Hematolgy
RECRUITING
Linköping
Sunderbyn Hospital, Dept of Medicine
NOT_YET_RECRUITING
Luleå
Skane University Hospital
RECRUITING
Lund
Örebro University Hospital, Dept of Oncology
RECRUITING
Örebro
Karolinska University Hospital, Center of Hematology
RECRUITING
Stockholm
Norrland University Hospital, Dept of Oncology
NOT_YET_RECRUITING
Umeå
Academic Hospital, Dept of Oncology
RECRUITING
Uppsala
Contact Information
Primary
Döndü Gözel
Doendue.Goezel@med.uni-muenchen.de
+49 89 4400
Backup
Christian Schmidt, Dr.
Christian_Schmidt@med.uni-muenchen.de
+49 89 4400
Time Frame
Start Date: 2016-07
Estimated Completion Date: 2026-05
Participants
Target number of participants: 870
Treatments
Active_comparator: Standard Arm A
R-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
Experimental: Experimental Arm A+I
R-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)
Experimental: Experimental Arm I
R-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)
Sponsors
Leads: Prof. Dr. M. Dreyling (co-chairman)
Collaborators: LMU Klinikum

This content was sourced from clinicaltrials.gov