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Diffuse Large B Cell LymphomaPhase 3NCT02128061

Efficacy of Lenalidomide in Combination With Subcutaneous Rituximab + miniCHOP in DLBCL Patients of 80 y/o or+

A Phase 3 study testing Lenalidomide and Rituximab in people with Diffuse Large B Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 97 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the efficacy of R2-miniCHOP (Sub-cutaneous Rituximab-miniCHOP + lenalidomide) and R-miniCHOP (Sub-cutaneous Rituximab-miniCHOP) in patients aged 80 years old or more with not previously treated cluster of differentiation antigen 20 positive (CD20+) diffuse large B-cell lymphoma… Read more about this study

Who is it for?
Ages 80 years and older
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
Lenalidomide and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
97 sitesin 2 countries
Study dates
Aug 2014to Jan 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2008) including all clinical subtypes (primary mediastinal, intravascular, etc…), with all age-adjusted International Prognostic Index (aaIPI).
  • 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
Show all 13Show fewer
  • 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)

Who cannot join

  • Any other histological type of lymphoma, Burkitt included
  • 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
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  • 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")

Trial locations and contacts

97 sites in 2 countries.

97 sites in 2 countries

France83 sites

  • CH d'Abbeville

    Abbeville, 80142

  • CH du Pays d'Aix

    Aix-en-Provence, 13606

  • CHU d'Amiens

    Amiens, 80054

  • CHU d'Angers

    Angers, 49000

  • CH Victor Dupouy

    Argenteuil, 95107

  • CH d'Arras

    Arras, 62022

  • CH d Avignon - Hopital Henri Duffaut

    Avignon, 84902

  • CH Côte Basque

    Bayonne, 64100

  • CHU Jean Minjoz

    Besançon, 25030

  • CH de Blois

    Blois, 41000

  • Institut Bergonié

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord

    Bordeaux, 33300

  • CH de Boulogne-sur-Mer

    Boulogne-sur-Mer, 62321

  • CH de Bourg en Bresse

    Bourg-en-Bresse, 01000

  • CHU Morvan

    Brest, 29609

  • CH de Brive

    Brivé, 19190

  • IHBN

    Caen

  • CH de Cannes

    Cannes, 06401

  • Clinique Du Parc

    Castelnau-le-Lez, 34170

  • Médipôle de Savoie

    Challes-les-Eaux, 73191

  • CHU de Châlon sur Sâone

    Chalon-sur-Sâone

  • CH Métropole Savoie

    Chambéry, 73011

  • Hôpital d'Instruction des Armées Percy

    Clamart, 92141

  • CHU Estaing

    Clermont-Ferrand, 63000

  • Pôle Santé République

    Clermont-Ferrand, 63050

  • CH Sud Francilien de Corbeil

    Corbeil-Essonnes, 91108

  • APHP - Hopital Henri Mondor

    Créteil, 94010

  • CHU de Dijon - Hôpital le Bocage

    Dijon, 21034

  • CH de Dunkerque

    Dunkirk, 59385

  • CH Eure Seine

    Évreux, 27015

  • CHU de Grenoble

    Grenoble, 38000

  • Institut Daniel Hollard

    Grenoble, 38028

  • CH Départemental de Vendée

    La Roche-sur-Yon

  • Hôpital St Louis

    La Rochelle, 17019

  • CH de Versailles - Hopital André Mignot

    Le Chesnay, 78157

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94275

  • CH du Mans

    Le Mans, 72000

  • Clinique Victor Hugo

    Le Mans, 72000

  • CHRU Lille - Hôpital Claude Huriez

    Lille, 59037

  • Hôpital Saint Vincent de Paul

    Lille

  • CHU de Limoges

    Limoges, 87042

  • Centre Léon Bérard

    Lyon

  • CH des Chanaux

    Mâcon, 71018

  • Institut Paoli Calmette

    Marseille, 13273

  • Hôpital de la conception

    Marseille, 13385

  • CH de Meaux

    Meaux, 77104

  • Hôpital de Mercy

    Metz, 57038

  • Centre Hospitalier Annecy Genevois

    Metz-Tessy, 74374

  • CHU de Montpellier

    Montpellier

  • CHU de Mulhouse

    Mulhouse, 68070

  • CHU de Nantes

    Nantes, 44093

  • Centre Antoine Lacassagne

    Nice, 06189

  • CHU de Nîmes

    Nîmes, 30029

  • CHR de la Source

    Orléans, 45100

  • Hopital Saint Antoine

    Paris, 75012

  • APHP - Hôpital Saint Louis

    Paris, 75475

  • Hôpital de la Pitié Salpêtrière

    Paris, 75651

  • APHP - Hôpital Necker

    Paris, 75743

  • Clinique Francheville

    Périgueux, 24004

  • CH Périgueux

    Périgueux, 24019

  • CH de Perpigan

    Perpignan, 66000

  • CHU du Haut Leveque

    Pessac, 33604

  • Chu Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Poitiers

    Poitiers, 96021

  • CH René Dubos

    Pontoise, 95301

  • CH de Cornouaille

    Quimper, 29107

  • CHU Robert Debre

    Reims, 51092

  • CHU de Rennes

    Rennes, 35033

  • CH de Roubaix

    Roubaix, 59100

  • Centre Henri Becquerel

    Rouen, 76038

  • CH de Saint Brieuc

    Saint-Brieuc, 22000

  • Centre René Huguenin - Institut Curie

    Saint-Cloud, 92210

  • Groupe Hospitalier Sud Réunion

    Saint-Pierre, 97448

  • CH Saint Quentin

    Saint-Quentin, 02321

  • CHU de Saint Malo

    St-Malo, 35400

  • Strasbourg Oncologie Libérale

    Strasbourg, 67000

  • CHU de Strasbourg

    Strasbourg, 67098

  • CHI Toulon La Seyne-sur-mer

    Toulon, 83056

  • CHU Purpan - Toulouse

    Toulouse, 31059

  • CHRU Bretonneau

    Tours, 37044

  • Hôpital de Valence

    Valence, 26953

  • CHU de Brabois

    Vandœuvre-lès-Nancy, 54511

  • CH de Bretagne Atlantique

    Vannes, 56017

Other trials in France

Belgium14 sites

  • ZNA Stuivenberg

    Antwerp

  • A. Z. Sint-Jan

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • Université Catholique de Louvain Saint Luc

    Brussels, 1200

  • Hôpital Erasme

    Brussels

  • Grand Hôpital de Charleroi

    Charleroi, 6000

  • Universitair Ziekenhuis Gent

    Ghent

  • AZ Groeninge

    Kortrijk, 8500

  • CHR Citadelle

    Liège, 4000

  • CHU de Liège

    Liège, 4000

  • Hôpital Sainte Elisabeth

    Namur, 5000

  • Clinique Saint Pierre

    Ottignies, 1340

  • CHR Peltzer La Tourelle

    Verviers, 4800

  • CHRU Mont Godinne

    Yvoir

Other trials in Belgium

About this study

Official title: Sub-cutaneous Rituximab-miniCHOP Versus Sub-cutaneous Rituximab-miniCHOP + Lenalidomide (R2-miniCHOP) in Diffuse Large B Cell Lymphoma for Patients of 80 Years Old or More. A Multicentric Phase III Study of the LYSA Association

The purpose of this study is to compare the efficacy of R2-miniCHOP (Sub-cutaneous Rituximab-miniCHOP + lenalidomide) and R-miniCHOP (Sub-cutaneous Rituximab-miniCHOP) in patients aged 80 years old or more with not previously treated cluster of differentiation antigen 20 positive (CD20+) diffuse large B-cell lymphoma as measured by the overall survival (OS).The SENIOR trial will evaluate the tolerance and efficacy of the combination of the R2-miniCHOP regimen and compare this experimental arm to the standard R-miniCHOP regimen.The statistical plan is based on the hypothesis of an increase by 15% of the 2y-OS in favor of the experimental arm, as compared to the reference arm (R-miniCHOP).

Read the detailed description

The purpose of this study is to compare the efficacy of R2-miniCHOP (Sub-cutaneous Rituximab-miniCHOP + lenalidomide) and R-miniCHOP (Sub-cutaneous Rituximab-miniCHOP) in patients aged 80 years old or more with not previously treated cluster of differentiation antigen 20 positive (CD20+) diffuse large B-cell lymphoma as measured by the overall survival (OS).

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.

Being tested
Lenalidomide, Rituximab
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02128061
Study groupRoleWhat they receive
R-miniCHOPActive comparatorAll 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
Receives: Drug: Rituximab
R2-miniCHOPExperimentalAll 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
Receives: Drug: Lenalidomide; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The overall survival (OS)

    OS will be measured from the date of randomization to the date of death from any cause. Alive patients will be censored at their last contact.

    Measured: OS rates at 2 years

Secondary outcomes (8)

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization into the study to the first observation of documented disease progression/relapse or death due to any cause. If a subject has not progressed or died, PFS will be censored at the time of last visit with adequate assessment.

    Measured: PFS rates at 2 years

  2. Event-Free Survival (EFS)

    EFS will be measured from the date of randomization to the date of first documented disease progression/relapse (Cheson 1999), initiation of new anti-lymphoma therapy or death from any cause. Patients without documented event at the time of analysis will be censored at their visit with adequate assessment.

    Measured: EFS rates at 2 years

  3. Duration of Response (DoR)

    DoR will be measured from the time of attainment of Complete Response/unconfirmed Complete Response (CR/CRu) or Partial Response (PR) to the date of first documented disease progression/relapse or death from any cause. Patients alive and free of progression will be censored at their last visit with adequate assessment.

    Measured: DoR rates at 2 years

  4. Disease-Free Survival (DFS)

    DFS will be measured from the date of attainment of a complete or unconfirmed complete response (at the end of treatment or at permanent treatment discontinuation evaluation) to the date of first observation of documented disease progression or death due to any cause. Complete Response/unconfirmed Complete Response (CR/CRu) patients who have not progressed or died will be censored at the time of last visit with adequate assessment.

    Measured: DFS rates at 2 years

  5. OS according to GCB/non-GCB phenotype

    OS will be described for the R2-miniCHOP group according to Hans algorithm (GCB/non-GCB phenotype).

    Measured: OS according to GCB/non-GCB phenotype rates at 2 years

  6. Response Rate at the end of treatment

    Disease response evaluation at end of treatment (after 6 cycles) will be used to determine the Response Rate. Response will be assessed at end of treatment (after end of the 6th cycle of treatment or at permanent treatment discontinuation).

    Assessment of response will be based on the International Workshop to Standardize Response criteria for non-Hodgkin's lymphoma (NHL) (Criteria for evaluation of response in NHL (Cheson, 1999)).

    Measured: 22 weeks (28 days after the end of the 6, three-weeks interval, cycles of treatment) or within 28 days following permanent treatment discontinuation

  7. Simplified Geriatric Scales

    Four geriatric tools will be performed before any chemotherapy administration (Instrumental Activities of Daily Living (IADL), Mini Nutritional Assessment (MNA), G8, and Cumulative Illness Rating Scale for Geriatrics (CIRS-G) scales). Each scale will be analyzed in order to have a picture of the population at baseline. Thereafter, the prognosis impact in OS and PFS of each scale will be evaluated using univariate (Kaplan Meier) and multivariate analyses (Cox model). Safety analyses will also be performed according to each scale in order to evaluate the toxicity predictive power of these scales.

    Measured: At baseline

  8. Health related Quality of Life (HRQOL)

    HRQOL will be assessed by the Quality of Life Questionnaire-C30 and Elderly14 (QLQ-C30 and the QLQ-ELD14) at randomization and at end of treatment. The improvement or not of the QoL will therefore be assessed.

    The QLQ-ELD14 was developed to supplement the QLQ-C30 for measuring HRQoL in patients aged >70 years in oncology studies.

    Measured: At randomization and 22 weeks after Day 1 of Cycle 1 of R-miniCHOP or R2-miniCHOP (28 days after the end of the 6, three-weeks interval, cycles of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2014 (estimated)
  2. Study startAug 2014
  3. Primary completion5 Nov 2018
  4. Study completionJan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02128061
Sponsor's protocol ID
SENIOR
Status last verified
Mar 2020
First submitted
23 Apr 2014
Last updated
13 Apr 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide and Rituximab in people with Diffuse Large B Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 97 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The overall survival (OS) (time frame: OS rates at 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02128061.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.

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