Efficacy of Lenalidomide in Combination With Subcutaneous Rituximab + miniCHOP in DLBCL Patients of 80 y/o or+
NCT ID: NCT02128061
Last Updated: 2021-04-13
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
PHASE3
250 participants
INTERVENTIONAL
2014-08-31
2021-01-31
Brief Summary
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Detailed Description
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Primary endpoint of the study is to compare the efficacy of R2-miniCHOP (Sub-cutaneous Rituximab-miniCHOP + lenalidomide) and R-miniCHOP ((Sub-cutaneous Rituximab-miniCHOP) in patients of 80 years old or more with not previously treated CD20+ diffuse large B-cell lymphoma as measured by the overall survival (OS).
Secondary endpoints are:
* To evaluate the efficacy and the safety of R2-miniCHOP as measured by the PFS (Progression Free Survival), EFS (Event Free Survival), the DoR (duration of response), the DFS (disease free survival), response rate at the end of the treatment, the additional toxicities
* To evaluate the simplified scale prognostic impact (IADL, MNA, G8, CIRS-G)
* To assess the quality of life before and after treatment This study is a multicentric, phase III, open-label, randomized (1:1) trial evaluating the efficacy of R2-miniCHOP in patients aged of 80 years or more with non-previously treated CD20+ diffuse large B-cell lymphoma (age-adjusted IPI= 0 to 3), Ann Arbor stage II to IV with a performance status ECOG from 0 to 2.
This study includes a run in phase to assess feasibility, safety and tolerance of subcutaneous rituximab injections and oral lenalidomide (10 mg D1-D14) in combination with dose-reduced intensity CHOP regimen.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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R-miniCHOP
All patients will be treated with R-miniCHOP at a three-weeks interval for 6 cycles CYCLOPHOSPHAMIDE IV: 400 mg/m² Day 1 (D1) DOXORUBICINE IV : 25 mg/m² D1 VINCRISTINE IV : 1 mg Total Dose (TD) D1 PREDNISONE PO : 40 mg/m² D1 to D5 RITUXIMAB SC\* : 1400 mg TD D1
\*The first cycle of rituximab is delivered by IV at the dose of 375 mg/m2
Rituximab
R2-miniCHOP
All patients will be treated with R2-miniCHOP at a three-weeks interval for 6 cycles CYCLOPHOSPHAMIDE IV: 400 mg/m² D1 - DOXORUBICINE IV : 25 mg/m² D1 - VINCRISTINE IV : 1 mg TD D1 - PREDNISONE PO : 40 mg/m² D1 to D5 - RITUXIMAB SC\* : 1400 mg TD D1 LENALIDOMIDE PO\*\* :10 mg TD D1 to D14
\*The first cycle of rituximab is delivered by IV at the dose of 375 mg/m2
Lenalidomide
Rituximab
Interventions
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Lenalidomide
Rituximab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
May also be included: De Novo transformed DLBCL from low grade lymphoma (Follicular, other...) and DLBCL associated with some small cell Infiltration in bone marrow or lymph node; or CD20+ B-cell lymphoma, with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma; or CD20+ Follicular lymphoma grade 3B (according to WHO classification); or CD20+ Aggressive B-cell lymphoma unclassifiable.
* With a Cluster of Differentiation antigen 10 (CD10) immunostaining performed by the participating center pathologist
* Aged ≥ 80 years old
* Ann Arbor stage II, III or IV
* Patient previously untreated for DLBCL Lymphoma
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* With a minimum life expectancy of 3 months
* Negative HIV, HBV and HCV serologies test within 4 weeks before inclusion (except after hepatitis B vaccination or for patients who are HBs Ag negative, anti-HBs positive and/or anti-HBc positive but viral DNA negative)
* Patient able to give his consent and having signed a written Informed consent
* Patient affiliated to social security system, if applicable
* Male patients must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 3 months following study drug discontinuation, even if they have undergone a successful vasectomy.
* All patients must agree to fulfill the global Lenalidomide Pregnancy Prevention Risk Management Plan as applicable according to the randomization arm (randomization arm)
Exclusion Criteria
* Any history of treated or non-treated small-B cell lymphoma
* Central nervous system or meningeal involvement by lymphoma
* Contra-indication to any drug contained in the chemotherapy regimens ; for anthracycline use, ejection fraction should be \> 50%
* Any serious active disease (according to the investigator's decision)
* History of deep venous thrombosis or arterial thromboembolism events within the past 12 months before inclusion
* Poor renal function (creatinine clearance \< 40 ml/min, according to Modification of Diet in Renal Disease (MDRD) formula)
* Poor hepatic function (total bilirubin level \>30mmol/l, transaminases \>2.5 maximum normal level) unless these abnormalities are related to the lymphoma
* Poor bone marrow reserve as defined by neutrophils \<1.5 G/l or platelets \<100 G/l, unless related to bone marrow infiltration
* Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma Patients previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score ≤7, and a prostate specific antigen (PSA) ≤10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (i.e., prostatectomy or radiotherapy) 2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or \<1 ng/mL if they did not undergo prostatectomy
* Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
* Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy
* Prior use of lenalidomide
* Prior ≥ Grade 3 allergic reaction/hypersensitivity to thalidomide
* Prior ≥ Grade 3 rash or any desquamating (blistering) rash while taking thalidomide
* Subjects with ≥ Grade 2 neuropathy
* Adult patient under tutelage
* Female of childbearing potential are excluded. (Note: Females are defined as not of childbearing potential if there is documentation of "natural menopause for at least 24 consecutive months, a hysterectomy or bilateral oophorectomy")
80 Years
ALL
No
Sponsors
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Centre Henri Becquerel
OTHER
The Lymphoma Academic Research Organisation
OTHER
Responsible Party
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Principal Investigators
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Fabrice Jardin, MD,Professor
Role: PRINCIPAL_INVESTIGATOR
The Lymphoma Study Association - LYSA
Locations
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ZNA Stuivenberg
Antwerp, , Belgium
A. Z. Sint-Jan
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Université Catholique de Louvain Saint Luc
Brussels, , Belgium
Hôpital Erasme
Brussels, , Belgium
Grand Hôpital de Charleroi
Charleroi, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
AZ Groeninge
Kortrijk, , Belgium
CHR Citadelle
Liège, , Belgium
CHU de Liège
Liège, , Belgium
Hôpital Sainte Elisabeth
Namur, , Belgium
Clinique Saint Pierre
Ottignies, , Belgium
CHR Peltzer La Tourelle
Verviers, , Belgium
CHRU Mont Godinne
Yvoir, , Belgium
CH d'Abbeville
Abbeville, , France
CH du Pays d'Aix
Aix-en-Provence, , France
CHU d'Amiens
Amiens, , France
CHU d'Angers
Angers, , France
CH Victor Dupouy
Argenteuil, , France
CH d'Arras
Arras, , France
CH d Avignon - Hopital Henri Duffaut
Avignon, , France
CH Côte Basque
Bayonne, , France
CHU Jean Minjoz
Besançon, , France
CH de Blois
Blois, , France
Institut Bergonié
Bordeaux, , France
Polyclinique Bordeaux Nord
Bordeaux, , France
CH de Boulogne-sur-Mer
Boulogne-sur-Mer, , France
CH de Bourg en Bresse
Bourg-en-Bresse, , France
CHU Morvan
Brest, , France
CH de Brive
Brivé, , France
IHBN
Caen, , France
CH de Cannes
Cannes, , France
Clinique Du Parc
Castelnau-le-Lez, , France
Médipôle de Savoie
Challes-les-Eaux, , France
CHU de Châlon sur Sâone
Chalon-sur-Sâone, , France
CH Métropole Savoie
Chambéry, , France
Hôpital d'Instruction des Armées Percy
Clamart, , France
CHU Estaing
Clermont-Ferrand, , France
Pôle Santé République
Clermont-Ferrand, , France
CH Sud Francilien de Corbeil
Corbeil-Essonnes, , France
APHP - Hopital Henri Mondor
Créteil, , France
CHU de Dijon - Hôpital le Bocage
Dijon, , France
CH de Dunkerque
Dunkirk, , France
CH Eure Seine
Évreux, , France
CHU de Grenoble
Grenoble, , France
Institut Daniel Hollard
Grenoble, , France
CH Départemental de Vendée
La Roche-sur-Yon, , France
Hôpital St Louis
La Rochelle, , France
CH de Versailles - Hopital André Mignot
Le Chesnay, , France
Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
CH du Mans
Le Mans, , France
Clinique Victor Hugo
Le Mans, , France
CHRU Lille - Hôpital Claude Huriez
Lille, , France
Hôpital Saint Vincent de Paul
Lille, , France
CHU de Limoges
Limoges, , France
Centre Léon Bérard
Lyon, , France
Institut Paoli Calmette
Marseille, , France
Hôpital de la conception
Marseille, , France
CH des Chanaux
Mâcon, , France
CH de Meaux
Meaux, , France
Hôpital de Mercy
Metz, , France
Centre Hospitalier Annecy Genevois
Metz-Tessy, , France
CHU de Montpellier
Montpellier, , France
CHU de Mulhouse
Mulhouse, , France
CHU de Nantes
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
CHU de Nîmes
Nîmes, , France
CHR de la Source
Orléans, , France
Hopital Saint Antoine
Paris, , France
APHP - Hôpital Saint Louis
Paris, , France
Hôpital de la Pitié Salpêtrière
Paris, , France
APHP - Hôpital Necker
Paris, , France
CH de Perpigan
Perpignan, , France
CHU du Haut Leveque
Pessac, , France
Clinique Francheville
Périgueux, , France
CH Périgueux
Périgueux, , France
Chu Lyon Sud
Pierre-Bénite, , France
CHU de Poitiers
Poitiers, , France
CH René Dubos
Pontoise, , France
CH de Cornouaille
Quimper, , France
CHU Robert Debre
Reims, , France
CHU de Rennes
Rennes, , France
CH de Roubaix
Roubaix, , France
Centre Henri Becquerel
Rouen, , France
CH de Saint Brieuc
Saint-Brieuc, , France
Centre René Huguenin - Institut Curie
Saint-Cloud, , France
Groupe Hospitalier Sud Réunion
Saint-Pierre, , France
CH Saint Quentin
Saint-Quentin, , France
CHU de Saint Malo
St-Malo, , France
Strasbourg Oncologie Libérale
Strasbourg, , France
CHU de Strasbourg
Strasbourg, , France
CHI Toulon La Seyne-sur-mer
Toulon, , France
CHU Purpan - Toulouse
Toulouse, , France
CHRU Bretonneau
Tours, , France
Hôpital de Valence
Valence, , France
CHU de Brabois
Vandœuvre-lès-Nancy, , France
CH de Bretagne Atlantique
Vannes, , France
Countries
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Other Identifiers
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SENIOR
Identifier Type: -
Identifier Source: org_study_id
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