Nivolumab With Gemcitabine, Oxaliplatin + Rituximab in r/r Elderly Lymphoma Patients
NCT ID: NCT03366272
Last Updated: 2025-01-28
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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COMPLETED
PHASE2/PHASE3
348 participants
INTERVENTIONAL
2017-12-05
2025-01-15
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)-GemOx
eight cycles of (R)-GemOx (Gemcitabine 1000 mg/m2, d1, Oxaliplatin 100 mg/m2, d1, Rituximab 375 mg/m2 in case of B-cell lymphoma disease, repeated every 2 wks)
Rituximab
eight cycles of R-GemOx in 2-wk intervals
Gemcitabine
eight cycles of (R)-GemOx in 2-wk intervals
Oxaliplatin
eight cycles of (R)-GemOx in 2-wk intervals
Nivo-(R)-GemOx
eight cycles of nivolumab (240 mg flatdose) plus (R)-GemOx in 2-wk intervals followed by additional 9 infusions of Nivolumab (480 mg flatdose) in 4-wk intervals as consolidation or up to progression or unacceptable toxicity, whatever occurs first
Nivolumab
eight cycles of nivolumab (240 mg flatdose) plus (R)-GemOx in 2-wk intervals followed by additional 9 infusions of Nivolumab (480 mg flatdose) in 4-wk intervals as consolidation or up to progression or unacceptable toxicity, whatever occurs first
Rituximab
eight cycles of R-GemOx in 2-wk intervals
Gemcitabine
eight cycles of (R)-GemOx in 2-wk intervals
Oxaliplatin
eight cycles of (R)-GemOx in 2-wk intervals
Interventions
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Nivolumab
eight cycles of nivolumab (240 mg flatdose) plus (R)-GemOx in 2-wk intervals followed by additional 9 infusions of Nivolumab (480 mg flatdose) in 4-wk intervals as consolidation or up to progression or unacceptable toxicity, whatever occurs first
Rituximab
eight cycles of R-GemOx in 2-wk intervals
Gemcitabine
eight cycles of (R)-GemOx in 2-wk intervals
Oxaliplatin
eight cycles of (R)-GemOx in 2-wk intervals
Eligibility Criteria
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Inclusion Criteria
* all patient \>65 years of age or \> 18 years if not eligible for neither autologous nor allogeneic stem cell transplantation
* all patient \>65 years of age or older than 18 years if HCT-CI score \> 2 or patients who underwent prior autologous stem cell transplantation and are not eligible for allogeneic stem cell Transplantation
* All risk groups (IPI 0 to 5)
* Diagnosis of aggressive Non-Hodgkin's lymphoma, based on an excisional biopsy of a lymph node or on an appropriate sample of a lymph node or of an extranodal involvement at initial diagnosis or relapse or Progression. The entities treated in the study will be based on the WHO 2017 classification.
* ECOG 0 - 2
* only one prior chemotherapy regimen including an anthracycline. The last cytotoxic drug must be given at least four weeks before entering the study. Rituximab must be part of the first-line regimen in case of B-cell lymphoma (except for primary CD20- negative lymphoma). Patients may have received prior radiation therapy as part of their first-line therapy
* Men who are sexually active with women of childbearing potential (WOCBP) must not father a child during and up to 6 months after GemOx and up to 12 months after Rituximab and/or Nivolumab. They are advised to do cryoconservation of sperm prior to treatment.
* Written informed consent of the patient
* Patient must be covered by social security system
* Persons not able to understand the impact, nature, risks and consequences of the trial (including language barrier)
* Persons not agreeing to the transmission of their pseudonymous data
* Persons depending on sponsor or investigator
* Persons from highly protected Groups
* Allergies and Adverse Drug Reaction History to study drug components
* Participation in another clinical trial with drug intervention within 4 weeks prior to start of the first cycle and during the study. However, participation in a clinical trial of firstline therapy of lymphoma is allowed.
Exclusion Criteria
* Serious accompanying disorder or impaired organ function
* WBC \< 2.5 G/l, Neutrophils \< 2 G/l, Platelets \< 100 G/l
* Prolongation of QTc interval \> 450 ms, demonstrated in one electrocardiogram (done as triplicate). This does not apply for patients with a block of the right and/or left bundle branch.
* Family history for Long QT-Syndrome
* active, known or suspected autoimmune disease
* no requirement for immunosuppressive doses of systemic corticosteroids
* Chronic active hepatitis B or C
* HIV-infection
* Patients with a severe immunodeficiency
* Previous therapy with Nivolumab,Gemcitabine or Oxaliplatin
* Patients with a "currently active" second malignancy other than non-melanoma skin cancer
* CNS involvement of lymphoma
* Persistent neuropathy grade \>2
* Pregnancy or breast-feeding women
* Women of childbearing potential
* Active serious infections not controlled by oral and/or intravenous antibiotics or anti-fungal medication
* Any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Lymphoma Study Association
OTHER
University of Leipzig
OTHER
Universität des Saarlandes
OTHER
Responsible Party
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Principal Investigators
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Gerhard Held, Prof
Role: PRINCIPAL_INVESTIGATOR
Universität des Saarlandes
Locations
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Landeskrankenhaus Feldkirch
Feldkirch, , Austria
Innsbruck University Hospital
Innsbruck, , Austria
Kepler Universitätsklinikum GmbH- Med. Campus III
Linz, , Austria
Ordensklinikum Linz - Elisabethinen
Linz, , Austria
Ordensklinikum Linz - Krankenhaus der Barmherzigen Schwestern Linz
Linz, , Austria
Paracelsus Medical University Salzburg
Salzburg, , Austria
Universitätsklinik für Innere Medizin I, AKH Wien
Vienna, , Austria
Klinikum Wels-Grieskirchen GmbH
Wels, , Austria
INSTITUT JULES BORDET -Hematology
Brussels, , Belgium
UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Hematology
Brussels, , Belgium
UNIVERSITAIR ZIEKENHUIS GENT - Hematology
Ghent, , Belgium
CHU DE LIEGE - Hematology
Liège, , Belgium
UNIVERSITE CATHOLIQUE DE LOUVAIN MONT GODINNE - Hematology
Yvoir, , Belgium
CHU Côte de Nacre - Service Hématologie Clinique
Caen, , France
Hôpital Henri Mondor - Unité "Hémopathies Lymphoïdes" - HDJ 11è
Créteil, , France
CHU Dijon - Hôpital d'Enfants - Hématologie Clinique
Dijon, , France
CHU de Grenoble - Hôpital Albert Michallon - Hématologie Clinique
Grenoble, , France
CH Départemental Vendée - Onco-Hématologie
La Roche-sur-Yon, , France
CHRU de Lille - Hôpital Claude Hurriez
Lille, , France
CHU de Montpellier - Hématologie Clinique
Montpellier, , France
CHU de Nantes - Hôtel Dieu - Hématologie
Nantes, , France
Hôpital Necker - Hématologie Clinique
Paris, , France
Hôpital Saint Louis - Onco-Hématologie
Paris, , France
CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie
Pessac, , France
CHU Lyon Sud - Hématologie
Pierre-Bénite, , France
Hôpital Pontchaillou - Hématologie
Rennes, , France
Centre Henri Becquerel - Hématologie
Rouen, , France
Institut de Cancèrologie Lucien Neuwirth
Saint-Priest-en-Jarez, , France
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, , France
IUCT Oncopole - Hématologie
Toulouse, , France
CHU Nancy - Hôpital de Brabois - Service d'Hématologie et Médecine Interne
Vandœuvre-lès-Nancy, , France
Sozialstiftung Bamberg
Bamberg, , Germany
Charité - Universitätsklinikum Berlin, Med. Klinik m. S. Hämatologie
Berlin, , Germany
Vivantes Klinikum am Urban, Klinik für Innere, Hämatologie und Onkologie
Berlin, , Germany
Klinikum Chemnitz, Innere Medizin III
Chemnitz, , Germany
BAG Freiberg-Richter, Jacobasch, Wolf, Illmer
Dresden, , Germany
Gemeinschaftspraxis Dres. Mohm, Prange-Krex
Dresden, , Germany
St. Antonius-Hospital Eschweiler, Klinik für Hämatologie
Eschweiler, , Germany
Universitätsklinikum Essen, Klinik für Hämatologie
Essen, , Germany
Universitätsmedizin Göttingen, Klinik für Hämatologie
Göttingen, , Germany
Universitätsklinikum Haale (Saale), Klinik für Innere Medizin IV
Haale, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitätsklinikum des Saarlandes, Innere Med. I
Homburg, , Germany
Westpfalz-Klinikum, Klinik für Innere Medizin I
Kaiserslautern, , Germany
St. Vincentius Kliniken Karlsruhe, Med. Klinik Abt. 2
Karlsruhe, , Germany
Uni Gießen und Marburg, Klinik für Hämatologie
Marburg, , Germany
Stauferklinikum Schwäbisch Gmünd, Zentrum für Innere Medizin
Mutlangen, , Germany
Klinikum der Universität München, Med. Klinik und Poliklinik III
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Brüderkrankenhaus St. Josef Paderborn
Paderborn, , Germany
Universitätsklinikum Regensburg, Klinik für Innere Medizin III
Regensburg, , Germany
Universitätsmedizin Rostock, Klinik für Hämatologie
Rostock, , Germany
Klinikum Stuttgart, Klinik für Hämatologie
Stuttgart, , Germany
Klinikum Mutterhaus der Borromäerinnen, Med. Abteilung I
Trier, , Germany
Krankenhaus der Barmherzigen Brüder, I. Med. Abteilung
Trier, , Germany
Universitätsklinikum Tübingen, Innere Medizin II
Tübingen, , Germany
Uniklinikum Ulm, Klinik für Innere Medizin III
Ulm, , Germany
Schwarzwald-Baar Klinikum, Innere Medizin II
Villingen-Schwenningen, , Germany
The Chaim Sheba Medical Center - Division of Hematology and Bone-Marrow Transplantation
Ramat Gan, , Israel
MC Alkmaar
Alkmaar, , Netherlands
AMC Academisch Medisch Centrum
Amsterdam, , Netherlands
VUMC
Amsterdam, , Netherlands
Reinier de Graaf Gasthuis
Delft, , Netherlands
Maxima Medisch Centrum
Eindhoven, , Netherlands
MC Leeuwarden Zuid
Leeuwarden, , Netherlands
Antonius Ziekenhuis
Nieuwegein, , Netherlands
Radboudumc Nijmegen
Nijmegen, , Netherlands
Szpital Specjalistyczny w Brozowie
Brzozów, , Poland
Oncologic Center
Bydgoszcz, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Swietorkrzyskie Centrum Oncologii
Kielce, , Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr. 1
Lublin, , Poland
Oncologic Center
Tomaszów Mazowiecki, , Poland
Marie Sklodowska-Curie Institute and Oncology
Warsaw, , Poland
Wojskowy Instytut Medyczny
Warsaw, , Poland
Instituto Português Oncologia - Hematology
Lisbon, , Portugal
Countries
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Other Identifiers
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DSHNHL 2015-1
Identifier Type: -
Identifier Source: org_study_id
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