diffuse large B cell lymphoma
Conditions
Interventions
Trade Name: revlimid
Pharmaceutical Form: Capsule, hard
Trade Name: gemcitabine
Pharmaceutical Form: Powder for solution for infusion
Trade Name: oxaliplatine
Pharmaceutical Form: Solution for infus
Sponsors
CHU Amiens-Picardie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 75 years old 2. Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2008) including all clinical subtypes (primary mediastinal, intravascular, etc...), with all aaIPI. May also be included : 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 or CD20+ Aggressive B-cell lymphoma unclassifiable? 3. Relapse = 6 months 4. ADL = 2 5. Negative HIV, HBV (anti-HBc negativity) and HCV serologies test within 4 weeks before inclusion 6. Patient able to give consent and has signed a written informed consent 7. Patient should comply with Celgene’s pregnancy prevention plan for Lenalidomide , if randomized to receive lenalidomide 8. Patient registered in the national health-care system 9. Patients with a minimum life expectancy of 4 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 114
Exclusion criteria
Exclusion criteria: 1. Tout autre type histologique de lymphome , y compris les lymphomes à petites cellules B traités 2. Lymphome avec atteinte du Système nerveux central ou atteinte méningée 3. Toute maladie grave active 4. Fonction rénale : clairance de la créatinine 30 mmol/l, taux de transaminases > 2,5 maximum normal), sauf si ces anomalies sont liées au lymphome 6. Neuropathie de grade > 1 7. Insuffisance médullaire, définie par un taux de neutrophiles<1,5 G/l ou des plaquettes <100 G/l, sauf si elle est liée à une infiltration de moelle osseuse 8. Autres affections malignes concomitantes ou antérieures, à l'exception d'un carcinome in situ du col utérin traité de manière adéquate, d'un carcinome basocellulaire ou squameux de la peau, ou d'un cancer en rémission complète depuis <5 ans 9. Traitement préalable par un anticorps monoclonal anti-CD20 dans les 6 mois précédant le début de la thérapie 10. Utilisation préalable de lénalidomide 11. Traitement par tout médicament expérimental dans les 30 jours précédant le premier cycle de chimiothérapie prévu et pendant l'étude 12. Réaction allergique ou hypersensibilité aux imides de grade 3 ou 4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -progression free survival at 6 months with maintain autonomy without loss of 0.5 point of ADL in elderly patients 75 years old and over with relapsed diffuse large B-cell lymphoma treated with Rituximab plus Lenalidomide or Rituximab plus investigator’s choice (R -GEMOX ou R-bendamustine);Secondary Objective: -Evaluate response rate and overall survival in each arm of treatment -Correlate the geriatric parameters studied (G8, albumin level, depression, falls in the previous year) with overall survival in each arm. -Evaluate quality of life before, during, and after the treatment in each arm -Evaluate toxicity according to the National Cancer Institute Toxicity Criteria -Evaluate safety in real-time. -Evaluate rate of institutionalization at 6 months ;Primary end point(s): PFS with maintain of autonomy at 6 months -Progression free survival is defined as the time interval between randomization and the date of progression or death, whatever occurs first. If a subject has not progressed or died, PFS will be censored at the time of last visit with adequate assessment. The disease progression status will be assessed using the Cheson 14 criteria (Appendix 2). -ADL scale ranks adequacy of performance in six functions (bathing, dressing, toileting, transferring, continence, and feeding) (Appendix 1). The maintain of autonomy is defined as no loss more than 0.5 point of baseline score at 6 months ;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall response rate is defined with CT scan according to Cheson 2014 criteria - Overall survival at 2 years is calculated from the date of randomization until death from any cause - G8 questionnaire, Albumin and weight, Mini GDS scale, falls in the previous year (Appendix 3 and 5 - QLQ-ELD14 at baseline, at end of induction , at end of treatment and 2 years post randomization (Appendix 4) - Toxicity (NCI-CTCAE v5.0) at each course (Appendix 6) - Number of toxic deaths and the number of hospitalizations for severe adverse events or decompensation of comorbidities related to treatment for the monitoring of safety - Rate of institutionalization at 6 months - Impact of miniDataset (G-CODE) on toxicities and survival (Appendix 7) at baseline, at end of induction , at end of treatment and 2 years post randomisation ;Timepoint(s) of evaluation of this end point: 1 year after last administration of lenalidomide | — |
Countries
France
Outcome results
None listed