ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma
NCT ID: NCT02858258
Last Updated: 2017-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
870 participants
INTERVENTIONAL
2016-07-31
2026-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
R-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)
ASCT 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)
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)
R-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)
Ibrutinib (Induction)
Ibrutinib: only in cycle 1,3,5 on Day 1-19
ASCT 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)
Ibrutinib (Maintenance)
Ibrutinib (Maintenance), daily 560 mg for 2 years;
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)
R-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)
Ibrutinib (Induction)
Ibrutinib: only in cycle 1,3,5 on Day 1-19
Ibrutinib (Maintenance)
Ibrutinib (Maintenance), daily 560 mg for 2 years;
Interventions
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R-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)
Ibrutinib (Induction)
Ibrutinib: only in cycle 1,3,5 on Day 1-19
ASCT 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)
Ibrutinib (Maintenance)
Ibrutinib (Maintenance), daily 560 mg for 2 years;
Other Intervention Names
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Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
* 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.
* 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.
18 Years
65 Years
ALL
No
Sponsors
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LMU Klinikum
OTHER
Prof. Dr. M. Dreyling (co-chairman)
OTHER
Responsible Party
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Prof. Dr. M. Dreyling (co-chairman)
Sponsor Delegated Person / Coordinating Prinicipal Investigator
Principal Investigators
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Martin Dreyling, Prof.
Role: PRINCIPAL_INVESTIGATOR
Klinikum der Universität München
Locations
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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
Napoli, , 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
Countries
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Central Contacts
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Facility Contacts
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Christian Schmidt, Dr.
Role: primary
Mats Jerkeman, MD
Role: primary
References
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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.
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.
Other Identifiers
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TRIANGLE
Identifier Type: -
Identifier Source: org_study_id