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

• Status: Completed
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

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 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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Lymphoma Academic Research Organisation
• Collaborator: Centre Henri Becquerel
• Treatments: Lenalidomide; Rituximab; Thalidomide

Criteria

Inclusion Criteria:

• 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

• 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 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

• 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")