Efficacy and Safety of R-HAD Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory MCL
NCT ID: NCT01449344
Last Updated: 2017-03-07
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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UNKNOWN
PHASE3
128 participants
INTERVENTIONAL
2009-05-09
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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R-HAD + Bortezomib
Rituximab
Rituximab 375mg/m² IV , day 1
High dose Ara-C
Ara-C 2000 mg/m² (patients \>65 years or s/p myeloablative treatment: 1000 mg/m²) IV, d 2 and 3
Dexamethasone
Dexamethasone 40 mg PO, day 1-4
Bortezomib
Bortezomib 1.5 mg/m² IV, day 1 and 4
R-HAD
Rituximab
Rituximab 375mg/m² IV , day 1
High dose Ara-C
Ara-C 2000 mg/m² (patients \>65 years or s/p myeloablative treatment: 1000 mg/m²) IV, d 2 and 3
Dexamethasone
Dexamethasone 40 mg PO, day 1-4
Interventions
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Rituximab
Rituximab 375mg/m² IV , day 1
High dose Ara-C
Ara-C 2000 mg/m² (patients \>65 years or s/p myeloablative treatment: 1000 mg/m²) IV, d 2 and 3
Dexamethasone
Dexamethasone 40 mg PO, day 1-4
Bortezomib
Bortezomib 1.5 mg/m² IV, day 1 and 4
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Relapse or progression following 1 to 3 prior lines of anti-neoplastic standard therapy. Therapy in remission after initial induction like intensified chemotherapy for stem cell separation followed by myeloablative therapy or any kind of maintenance therapy is classified as one line of therapy with the induction therapy..
* If Rituximab was part of prior treatment, documented time to progression must be at least 12 weeks after this particular regimen.
* If high-dose Ara-C was part of prior treatment, documented time to progression must be at least 6 months after this particular regimen.
* Patients relapsed after autologous stem cell transplantation or not appropriate for myeloablative treatment.
* At least 1 measurable or assessable site of disease; in case of bone marrow infiltration only, bone marrow aspiration/ biopsy is mandatory for all staging evaluations.
* age \> 18 years
* ECOG/WHO Performance Score 0-2 unless lymphoma related.
* The following laboratory values at screening, unless lymphoma related:
* Absolute neutrophil count (ANC) \> = 1500 cells/microlitre
* Platelets \> = 100,000 cells/microlitre
* Transaminases (AST and ALT) \<=3 x upper limit of normal (ULN)
* Total bilirubin \<=2 x ULN
* Creatinine \<=2 mg/dL or calculated creatinine clearance \>=50 mL/min
* Toxic effects of previous therapy or surgery resolved to NCI CTC grade 2 or better.
* Premenopausal fertile females must agree to use a highly effective method of birth control for the duration of the therapy. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
* Men must agree not to father a child for the duration of therapy and must agree to advice a female partner to use a highly effective method of birth control.
* Written informed consent before performance of any study-related procedure.
Exclusion Criteria
* Treatment within another clinical trial within 30 days before trial entry or planned during this trial
* Anti-neoplastic (including radiation and antibody treatment) or experimental therapy within 4 weeks before planed Day 1 of Cycle 1 (Nitrosoureas within 6 weeks ) or radioimmunoconjugates or toxin immunoconjugates such as Ibritumomab tiuxetan (Zevalin™) or Tositumomab (Bexxar®) within 12 weeks before planed Day 1 of Cycle 1
* Known hypersensitivity to Rituximab, boron or mannitol.
* Active malignancy other than MCL within 5 years before Day 1 of Cycle 1, with the exception of complete resection of basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy.
* Active systemic infection requiring treatment.
* HIV, hepatitis B or C
* Patient has \>= grade 2 peripheral sensory neuropathy or neuropathic pain defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE).
* Symptomatic degenerative or toxic encephalopathy
* Serious medical condition (such as severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease, systemic infections etc) or psychiatric illness likely to interfere with participation in this clinical study
* Female subject is pregnant or breast-feeding (pregnancy testing is mandatory for premenopausal women).
18 Years
ALL
No
Sponsors
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Klinikum der Universitaet Muenchen, Grosshadern
OTHER
ClinAssess GmbH
INDUSTRY
GELARC Service de Pharmacovigilance, Pierre Benite
UNKNOWN
Prof. Dr. M. Dreyling (co-chairman)
OTHER
Responsible Party
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Prof. Dr. M. Dreyling (co-chairman)
Coordinating investigator, Germany
Principal Investigators
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Martin Dreyling, MD
Role: PRINCIPAL_INVESTIGATOR
Klinikum der Universität München, Grosshadern
Locations
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CH Victor Dupouy, Service hématologie
Argenteuil, , France
Centre Hospitalier de la côte Basque, Service hématologie
Bayonne, , France
CH de Blois, Service hématologie
Blois, , France
Institut Bergonie, Service Hématologie
Bordeaux, , France
CH Sud Francilien de Corbeil, Service hématologie
Corbeil-Essonnes, , France
Hôpital Henri Mondor, Service hématologie
Créteil, , France
Hôpital Albert Michallon, Service hématologie
Grenoble, , France
CH Mulhouse, Service hématologie
Le Mans, , France
Clinique Victor Hugo, Service hématologie
Le Mans, , France
CH du Mans, Service hématologie
Le Mans, , France
CHU de Nice, Service hématologie
Nice, , France
CHU Necker, Service d'hématologie - adulte
Paris, , France
Hôpital Haut Lévêque, Service hématologie
Pessac, , France
CHU Lyon Sud, Service hématologie
Pierre-Bénite, , France
Hôpital Jean Bernard, Service hématologie
Poitiers, , France
CH René Dubos, Service hématologie
Pontoise, , France
CHU Robert Debré, Service hématologie
Reims, , France
Hôpital Bretonneau, Service hématologie, Bâtiment H. Kaplan
Tours, , France
CHU Brabois, Service hématologie
Vandœuvre-lès-Nancy, , France
CH de Bretagne Atlantique, Service Hématologie
Vannes, , France
Institut Gustave ROUSSY
Villejuif, , France
Kreisklinik Altötting-Burghausen, Sektion Hämatologie/Onkologie und Palliativmedizin
Altötting, , Germany
Klinikum St. Marien, Med. Klinik II
Amberg, , Germany
Vivantes Klinikum Neukölln, Medizinische Klinik I - Hämatologie und Onkologie
Berlin, , Germany
Knappschaftskrankenhaus, Onkologische Ambulanz
Bottrop, , Germany
Praxis für Hämatologie/Onkologie,
Burgwedel, , Germany
Klinikum der Universität zu Köln, Klinik I f. Innere Medizin
Cologne, , Germany
Marien Hospital Düsseldorf
Düsseldorf, , Germany
Universitätsklinik Essen, Klinik für Hämatologie
Essen, , Germany
Klinikum der J.W. Goethe-Universtität Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie
Frankfurt am Main, , Germany
Ernst-Moritz-Arndt-Universität, Hämatologie/Onkologie
Greifswald, , Germany
Kath. Krankenhaus Hagen gem. GmbH St.-Marien-Hospital
Hagen, , Germany
Asklepios Klinik St. Georg, Abteilung Hämatologie
Hamburg, , Germany
St.-Marien-Hopsital Gem. GmbH
Hamm, , Germany
Universitätsklinik des Saarlandes
Homburg/Saar, , Germany
Westpfalz-Klinikum GmbH, I. Medizinische Klinik
Kaiserslautern, , Germany
UKSH im Städt. Krankenhaus Kiel, II. Med. Klinik und Poliklinik im SSK
Kiel, , Germany
Praxis Dr. Vehling-Kaiser
Landshut, , Germany
Klinikum Magdeburg gemeinnützige GmbH, Klinik f. Hämatologie/Onkologie
Magdeburg, , Germany
Klinikum d. Phillips-Universität, Klinik für Innere Medizin Hämatol./Onkologie/Immunologie
Marburg, , Germany
Kliniken Maria Hilf GmbH (Krankenhaus St. Franziskus)
Mönchengladbach, , Germany
Klinikum Schwäbisch Gmünd, Zentrum Innere Medizin
Mutlangen, , Germany
LMU München - Klinikum Großhadern Medizinische Klinik III
München, , Germany
Klinikum Nord Nürnberg, 5. Med. Klinik, Onkologie/Hämatologie
Nuremberg, , Germany
Schlossberg Klinik, Oberstaufen Internistische Onkologie
Oberstaufen, , Germany
Diakonie Klinikum Jung Stilling Krankenhaus
Siegen, , Germany
Diakonieklinikum Stuttgart, Medizinische Klinik II
Stuttgart, , Germany
Robert-Bosch-Krankenhaus, Hämatologie/Onkologie
Stuttgart, , Germany
Mutterhaus der Borromäerinnen, Medizinische Abteilung
Trier, , Germany
Krankenhaus der Barmherzigen Brüder, 1. Medizinische Abteilung
Trier, , Germany
Universitätsklinikum Ulm, Innere Medizin III
Ulm, , Germany
Harz-Klinikum Wernigerode-Blankenburg GmbH, Innere Medizin, Hämato-Onkologie und Palliativmedizin
Wernigerode, , Germany
Ammerland-Klinik GmbH, Klinik für innere Medizin
Westerstede, , Germany
Heinrich-Braun-Krankenhaus, Klinik für Innere Medizin III
Zwickau, , Germany
Countries
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References
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Fischer L, Jiang L, Durig J, Schmidt C, Stilgenbauer S, Bouabdallah K, Solal-Celigny P, Scholz CW, Feugier P, de Wit M, Trappe RU, Hallek M, Graeven U, Hanel M, Hoffmann M, Delwail V, Macro M, Greiner J, Giagounidis AAN, Dargel B, Durot E, Foussard C, Silkenstedt E, Weigert O, Pott C, Klapper W, Hiddemann W, Unterhalt M, Hoster E, Ribrag V, Dreyling M. The addition of bortezomib to rituximab, high-dose cytarabine and dexamethasone in relapsed or refractory mantle cell lymphoma-a randomized, open-label phase III trial of the European mantle cell lymphoma network. Leukemia. 2024 Jun;38(6):1307-1314. doi: 10.1038/s41375-024-02254-2. Epub 2024 Apr 27.
Other Identifiers
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MCL2005-01
Identifier Type: -
Identifier Source: org_study_id
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