Actively Recruiting
ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma
Led by Prof. Dr. M. Dreyling (co-chairman) · Updated on 2017-12-19
870
Participants Needed
112
Research Sites
513 weeks
Total Duration
On this page
Sponsors
P
Prof. Dr. M. Dreyling (co-chairman)
Lead Sponsor
L
LMU Klinikum
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of Mantle Cell Lymphoma according to WHO classification
- Suitable for high-dose treatment including high-dose Ara-C
- Stage II-IV (Ann Arbor classification)
- Age 18 to 65 years
- Previously untreated Mantle Cell Lymphoma
- At least one measurable lesion; bone marrow biopsy required if only bone marrow is involved
- ECOG/WHO performance status of 0 to 2
- Adequate laboratory values: ANC ≥ 1000 cells/µL, platelets ≥ 100,000 cells/µL, AST and ALT ≤ 3 times upper limit of normal, total bilirubin ≤ 2 times upper limit of normal unless Gilbert-Meulengracht Syndrome, creatinine ≤ 2 mg/dL or creatinine clearance ≥ 50 mL/min
- Written informed consent according to regulations
- Sexually active men and women of child-bearing potential must agree to use highly effective contraception during the study and for 90 days after last dose
You will not qualify if you...
- Major surgery within 4 weeks before randomization
- Need for anticoagulation with warfarin or similar vitamin K antagonists
- History of stroke or brain bleeding within 6 months before randomization
- Need for treatment with strong CYP3A4/5 inhibitors
- Any life-threatening illness or organ dysfunction that could affect safety or study outcomes
- Vaccination with live attenuated vaccines within 4 weeks before randomization
- Known central nervous system involvement by Mantle Cell Lymphoma
- Significant allergic reactions to ibrutinib or its components
- Known hypersensitivity to murine antibodies or anti-murine antibody reactivity
- Prior lymphoma treatment except prephase therapy per protocol
- Serious heart disease, uncontrolled arrhythmias, heart failure, or recent heart attack
- Serious lung disease causing low oxygen levels
- Severe uncontrolled diabetes
- Kidney or liver impairment not caused by lymphoma
- Active hepatitis B or C infection or known HIV infection
- Previous organ, bone marrow, or stem cell transplantation
- Other cancers within the last 3 years except certain skin or cervical cancers
- Pregnancy or breastfeeding
- Any condition that may prevent compliance with study or follow-up
- Unable to give consent or understand the trial
- Participation in another clinical trial within 30 days before randomization in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 112 locations
1
Aalborg University Hospital, Dept of Hematology
Aalborg, Denmark, 9000
Not Yet Recruiting
2
Aarhus University Hospital, Dept of Hematology
Aarhus C, Denmark, 8000
Not Yet Recruiting
3
Rigshospitalet, Clinic of Hematology
Copenhagen, Denmark, 2100
Not Yet Recruiting
4
Herlev Hospital, Department of Hematology L121
Herlev, Denmark, 2730
Not Yet Recruiting
5
Odense University Hospital, Dept of Hematology X
Odense C, Denmark, 5000
Not Yet Recruiting
6
Sjaelland University Hospital, Dept of Hematology
Roskilde, Denmark, 4000
Not Yet Recruiting
7
Zentralklinik Augsburg, II. Med. Klinik, Hämatologie int. Onkologie
Augsburg, Germany, 86156
Actively Recruiting
8
Onkologische Gemeinschaftspraxis Dr. Janssen/Dr. Reichert in der Ubbo-Emmius-Klinik
Aurich, Germany, 26603
Actively Recruiting
9
Klinikum Bayreuth, Klinik f. Onkologie und Hämatologie
Bayreuth, Germany, 95445
Actively Recruiting
10
Vivantes Klinikum Am Urban, Klinik f. Innere Medizin, Hämatologie und Onkologie
Berlin, Germany, 10967
Actively Recruiting
11
Charité Univ.-Medizin Berlin, Med. Klinik - Hämatologie, Onkologie und Tumorimmunologie
Berlin, Germany, 12200
Not Yet Recruiting
12
Helios Klinikum Berlin-Buch, Hämatologie, Onkologie und Tumorimmunologie
Berlin, Germany, 13125
Actively Recruiting
13
Knappschaftskrankenhaus Bochum-Langendreer
Bochum, Germany, 44892
Actively Recruiting
14
Universitätsklinikum Bonn
Bonn, Germany, 53127
Actively Recruiting
15
Diako ev. Diakonie-KH gGmbH, Med. Klinik II, Hämatologie und Onkologie
Bremen, Germany, 28239
Actively Recruiting
16
Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin II
Chemnitz, Germany, 09113
Actively Recruiting
17
Uniklinik Köln, Klinik I für Innere Medizin
Cologne, Germany, 50937
Actively Recruiting
18
DONAUISAR Klinikum Deggendorf, Innere Medizin II
Deggendorf, Germany, 94469
Actively Recruiting
19
St.-Johannes-Hospital
Dortmund, Germany, 44137
Actively Recruiting
20
Gemeinschaftspraxis Dr. Mohm und Prange-Krex - Fachärzte für Innere Medizin und Hämatologie und Onkologie
Dresden, Germany, 01307
Actively Recruiting
21
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Germany, 01307
Actively Recruiting
22
Universitätsklinikum Düsseldorf, Klinik f. Hämatologie, Onkologie und klinische Immunologie
Düsseldorf, Germany, 40225
Actively Recruiting
23
Marien Hospital Düsseldorf
Düsseldorf, Germany, 40479
Actively Recruiting
24
Helios Klinikum Erfurt GmbH, Zentrum f. Innere Medizin u. internistische Onkologie, Hämostaseologie
Erfurt, Germany, 99089
Actively Recruiting
25
Universitätsklinikum Erlangen, Med. Klinik 5, Hämatologie und internistische Onkologie
Erlangen, Germany, 91054
Actively Recruiting
26
St.-Antonius-Hospital Eschweiler, Klinik für Hämatologie und Onkologie
Eschweiler, Germany, 52249
Actively Recruiting
27
Universitätsklinikum Essen, Klinik f. Hämatologie
Essen, Germany, 45147
Actively Recruiting
28
Universitätsklinikum Freiburg, Klinik f. Innere Medizin, Hämatologie, Onkologie u. Stammzelltransplantation
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
29
Universitätsmedizin Göttingen, Zentrum f. Innere Medizin, Klinik f. Hämatologie und Medizinische Onkologie
Göttingen, Germany, 37075
Actively Recruiting
30
Universitätsmedizin Greifswald, Klinik u. Poliklinik f. Innere Medizin C, Hämatologie u. Onkologie-, Transplantationszentrum
Greifswald, Germany, 17475
Actively Recruiting
31
Katholisches Krankenhaus Hagen gGmbH, St.-Marien-Hospital, Klinik f. Hämatologie und Onkologie
Hagen, Germany, 58095
Actively Recruiting
32
Universitätsklinikum Hamburg-Eppendorf (UKE), II. Med. Klinik u. Poliklinik, Onkologie, Hämatologie, KMT
Hamburg, Germany, 20246
Actively Recruiting
33
Asklepios Klinik Altona, II. Med.Abt. f. Hämatologie und internistische Onkologie, Stammzelltransplantation
Hamburg, Germany, 22763
Actively Recruiting
34
Universitätsklinikum Heidelberg, Med. Klinik - Innere Medizin V - Hämatologie, Onkologie und Rheumatologie
Heidelberg, Germany, 69120
Actively Recruiting
35
Universitätsklinikum des Saarlandes, Klinik f. Innere Medizin I Hämatologie & Onkologie
Homburg, Germany, 66421
Actively Recruiting
36
Klinikum Idar-Oberstein GmbH, Medizinische Klinik I
Idar-Oberstein, Germany, 55743
Actively Recruiting
37
Universitätsmedizin Jena, Klinik f. Innere Medizin II, Abteilung Hämatologie u. Internistische Onkologie
Jena, Germany, 07747
Actively Recruiting
38
Städtisches Klinikum Karlsruhe, Med. Klinik III, Hämatologie und Onkologie
Karlsruhe, Germany, 76133
Actively Recruiting
39
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik f. Innere Medizin II - Hämatologie und Onkologie
Kiel, Germany, 24105
Actively Recruiting
40
Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin, Klinik f. Innere Medizin
Koblenz, Germany, 56068
Actively Recruiting
41
Praxisklinik f. Hämatologie und Onkologie Koblenz
Koblenz, Germany, 56068
Actively Recruiting
42
Onkologisch-Hämatologische Praxis Dr. Vehling-Kaiser
Landshut, Germany, 84028
Actively Recruiting
43
Klinikum Landshut gGmbH, Med. Klinik III, Hämatologie/Internistische Onkologie
Landshut, Germany, 84034
Actively Recruiting
44
Caritas-KHLebach, Gemeinschaftspraxis f. Hämatologie und Onkologie, Onkologisches Zentrum Lebach
Lebach, Germany, 66822
Actively Recruiting
45
Universitätsklinikum Leipzig AöR, selbständige Abteilung f. Hämatologie und Internistische Onkologie, Hämostaseologische Ambulanz
Leipzig, Germany, 04103
Actively Recruiting
46
Klinikum Lippe GmbH, Onkologie und Hämatologie
Lemgo, Germany, 32657
Actively Recruiting
47
Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Med. Klinik A
Ludwigshafen, Germany, 67063
Actively Recruiting
48
Universitätsklinikum Magdeburg AöR, Klinik f. Hämatologie und Onkologie
Magdeburg, Germany, 39120
Actively Recruiting
49
Universitätsmedizin der Univ. Mainz, III. Med. Klinik u. Poliklinik
Mainz, Germany, 55131
Actively Recruiting
50
Johannes Wiesling Klinikum Minden, Klinik f. Hämatologie/Onkologie, Hämostaseologie und Palliativmedizin
Minden, Germany, 32429
Actively Recruiting
51
Klinikum der Universität München, Med. Klinik und Poliklinik III
München, Germany, 81377
Actively Recruiting
52
Klinikum Rechts der Isar, III. Med. Klinik - Hämatologie und Onkologie
München, Germany, 81675
Actively Recruiting
53
Universitätsklinikum Münster, Med. Klinik A, Translationale Onkologie / Lymphome
Münster, Germany, 48149
Actively Recruiting
54
Klinikum Nürnberg,5. Medizinische Klinik, Onkologie / Hämatologie
Nuremberg, Germany, 90419
Actively Recruiting
55
Klinikum Oldenburg gGmbH, Med. Klinik II
Oldenburg, Germany, 26133
Actively Recruiting
56
Klinikum Ernst von Bergmann Potsdam gGmbH, Zentrum f. Innere Medizin, Klinik f. Hämatologie und Onkologie
Potsdam, Germany, 14467
Actively Recruiting
57
KH Barmherzige Brüder, Klinik f. Onkologie und Hämatologie
Regensburg, Germany, 93049
Actively Recruiting
58
Universitätsmedizin Rostock, Abt. f. Hämatologie und Onkologie, Klinik und Poliklinik für Innere Medizin
Rostock, Germany, 18057
Actively Recruiting
59
Klinikum Stuttgart - Katharinenhospital, Klinik f. Hämatologie und Onkologie
Stuttgart, Germany, 70174
Actively Recruiting
60
Robert-Bosch-Krankenhaus, Abt.f. Hämatologie und Onkologie
Stuttgart, Germany, 70376
Actively Recruiting
61
Klinikum Traunstein, Hämatologie - Onkologie- Palliativmedizin
Traunstein, Germany, 83278
Actively Recruiting
62
Klinikum Mutterhaus der Borromäerinnen gGmbH, Okologisches Zentrum
Trier, Germany, 54290
Actively Recruiting
63
Universitätsklinikum Tübingen, Med Klinik I, Innere Medizin II
Tübingen, Germany, 72026
Actively Recruiting
64
Universitätsklinikum Ulm, Klinik für Innere Medizin III
Ulm, Germany, 89081
Actively Recruiting
65
Klinikum Wolfsburg, Med. Klinik II
Wolfsburg, Germany, 38440
Actively Recruiting
66
Universitätsklinikum Würzburg, Med. Klinik u. Poliklinik II /ZIM
Würzburg, Germany, 97080
Not Yet Recruiting
67
Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo, SC Ematologia
Alessandria, Italy, 15121
Actively Recruiting
68
Policlinico S. Orsola Malpighi, Istituto di Ematologia e Oncologia Medica Seragnoli
Bologna, Italy, 40138
Not Yet Recruiting
69
Comprensorio Sanitario di Bolzano, Ematologia e trapianto di midollo osseo
Bolzano, Italy, 39100
Not Yet Recruiting
70
Spedali Civili, Struttura Complessa di Ematologia
Brescia, Italy, 25123
Not Yet Recruiting
71
Ospedale Businco, UO Ematologia - CTMO
Cagliari, Italy, 09121
Not Yet Recruiting
72
ASO S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo
Cuneo, Italy, 12100
Not Yet Recruiting
73
AOU Policlinico Careggi, Unità Funzionale di Ematologia
Florence, Italy, 50134
Not Yet Recruiting
74
IRCCS AOU S. Martino - IST, Clinica Ematologia
Genova, Italy, 16132
Not Yet Recruiting
75
IRCCS AOU S. Martino - IST, Ematologia
Genova, Italy, 16132
Not Yet Recruiting
76
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Ematologia
Meldola (FC), Italy, 47014
Not Yet Recruiting
77
Istituto Scientifico San Raffaele, Unità Ricerca Clinica Linfomi
Milan, Italy, 20132
Not Yet Recruiting
78
Ospedale Niguarda, Struttura Complessa di Ematologia
Milan, Italy, 20162
Not Yet Recruiting
79
Università di Modena e Reggio Emilia Policlinico - COM Centro Oncologico Modenese, Dipartimento di Oncologia ed Ematologia
Modena, Italy, 41124
Not Yet Recruiting
80
Ospedale S. Gerardo, Divisione di Ematologia
Monza, Italy, 20052
Not Yet Recruiting
81
"IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale", Ematologia Oncologica
Naples, Italy, 80131
Actively Recruiting
82
AOU Maggiore della Carità - Università del Piemonte Orientale, S.C.D.U Ematologia
Novara, Italy, 28100
Not Yet Recruiting
83
AO Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia
Palermo, Italy, 90146
Not Yet Recruiting
84
IRCCS Fondazione Policlinico San Matteo, Clinica Ematologia
Pavia, Italy, 27100
Not Yet Recruiting
85
Azienda Ospedaliera Pisana Ospedale "S.Chiara", Dipartimento di Oncologia Divisione di Ematologia
Pisa, Italy, 56126
Not Yet Recruiting
86
Ospedale S. Maria delle Croci, U.O di Ematologia
Ravenna, Italy, 48121
Not Yet Recruiting
87
Azienda Ospedaliera Bianchi, Melacrino, Morelli, Divisione di Ematologia
Reggio Calabria, Italy, 89125
Not Yet Recruiting
88
Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS, Ematologia
Reggio Emilia, Italy, 42123
Not Yet Recruiting
89
Ospedale degli Infermi, U.O. Ematologia
Rimini, Italy, 47923
Not Yet Recruiting
90
Policlinico Tor Vergata, UOC Oncoematologia
Roma, Italy, 00133
Not Yet Recruiting
91
Università La Sapienza, Ematologia
Roma, Italy, 00161
Not Yet Recruiting
92
Casa Sollievo della Sofferenza, U.O. Ematologia
San Giovanni Rotondo, Italy, 71013
Not Yet Recruiting
93
A.O. Città della Salute e della Scienza, SC Ematologia
Torino, Italy, 10126
Not Yet Recruiting
94
A.O. U. Città della Salute e della Scienza, S C Ematologia U
Torino, Italy, 10126
Not Yet Recruiting
95
Ospedale Cà Foncello, U.O.C. Ematologia
Treviso, Italy, 31100
Not Yet Recruiting
96
Ospedale Cardinale Panico, Divisione di Ematologia
Tricase, Italy, 73054
Not Yet Recruiting
97
ASUI Integrata di Udine, Clinica Ematologia
Udine, Italy, 33100
Not Yet Recruiting
98
Ospedale Policlinico G.B. Rossi, "Centro trapianto midollo osseo Ematologia"
Verona, Italy, 37134
Actively Recruiting
99
Ospedale S. Bortolo, Ematologia
Vicenza, Italy, 36100
Actively Recruiting
100
Haukeland University Hospital , Dept. of Oncology and Medical Physics
Bergen, Norway, 5021
Not Yet Recruiting
101
Oslo University Hospital, Dept of Oncology
Oslo, Norway, 0310
Not Yet Recruiting
102
Stavanger University Hospital, Division for Hematology&Oncology
Stavanger, Norway, 4011
Not Yet Recruiting
103
UNN Tromsø, Oncology Dep
Tromsø, Norway, 9038
Not Yet Recruiting
104
St. Olavs Hospital, Department of Oncology
Trondheim, Norway, 7006
Not Yet Recruiting
105
Sahlgrenska University Hospital, Section of Hematology and Coagulation, Dept of internal medicine
Gothenburg, Sweden, 413 45
Not Yet Recruiting
106
University Hospital, Dept of Hematolgy
Linköping, Sweden, 581 85
Actively Recruiting
107
Sunderbyn Hospital, Dept of Medicine
Luleå, Sweden, 971 80
Not Yet Recruiting
108
Skane University Hospital
Lund, Sweden, 221 85
Actively Recruiting
109
Örebro University Hospital, Dept of Oncology
Örebro, Sweden, 701 85
Actively Recruiting
110
Karolinska University Hospital, Center of Hematology
Stockholm, Sweden, 141 86
Actively Recruiting
111
Norrland University Hospital, Dept of Oncology
Umeå, Sweden, 901 85
Not Yet Recruiting
112
Academic Hospital, Dept of Oncology
Uppsala, Sweden, 751 85
Actively Recruiting
Research Team
D
Döndü Gözel
CONTACT
C
Christian Schmidt, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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