Diffuse Large B-cells non-Hodgkin Lymphoma MedDRA version: 20.0 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: REVLIMID - 5 MG CAPSULA RIGIDA - USO ORALE BLISTER (PCTFE/PVC/ALU) 21 CASPULE
Product Name: Revlimid 5 mg
Product Code: [IMP1]
Pharmaceutical Form: Capsule, hard
CAS Number: 191732-72-6
C
Sponsors
FONDAZIONE ITALIANA LINFOMI ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven CD20 positive Diffuse Large B-cell Lymphoma, according to WHO classification (local pathologist) 2. Age = 70 years 3. Previously untreated 4. CGA assessment performed before starting treatment 5. FRAIL patients defined as follows: Age >= 80 years (with UNFIT profile): ADL >= 5 residual functions and/or IADL >= 6 residual functions and/or CIRS: 0 comorbidity of grade 3-4 and 5-8 comorbidities of grade 2 Age 8 comorbidities of grade 2 6. Ann Arbor Stage I - IV 7. At least one bi-dimensionally measurable lesion defined as > 1.5 cm in its largest dimension on CT scan 8. ECOG performance status of 0- 3 9. No active hepatitis C virus (HCV) infection. In case of HCV positivity HCV-RNA is required. Only patients with HCV-RNA negative are accepted. 10. Adequate hematologic function (unless caused by bone marrow infiltrate), defined as follows: - Hemoglobin > 10 g/dL - WBC > 2500/mmc with PMN > 1000/ mmc - Platelets count = 75000/mmc - Creatinine clearance = 10 mL/min 11. Ability and willingness to comply with the study protocol procedure 12. Life expectancy > 6 months 13. Patients must give written informed consent. 14. Male subjects 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 at least 28 days following investigational product discontinuation, even if he has undergone a successful vasectomy. 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 68
Exclusion criteria
Exclusion criteria: 1. Histological diagnosis different from CD20 positive Diffuse Large B-cell Lymphoma are excluded. 2. Previous exposure to cytotoxic agents 3. Suspect or clinical evidence of CNS involvement by lymphoma 4. Contraindication to the use of Rituximab or of Lenalidomide 5. HBsAg positivity; HBsAg-negative patients with anti-HBc antibody can be enrolled if Hepatitis B Virus (HBV)-DNA are negative and antiviral treatment with Lamivudine or Tenofir is provided. 6. HIV positivity 7. Active herpes zoster infection; previously infected patients is accepted only with concomitant treatment with Valacyclovir 8. Any history of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer 9. AST /ALT > 2 x UNL; bilirubin > 2 x UNL; serum creatinine > 2.5 mg /dL 10. Creatinine clearance < 10 mL/min 11. Evidence of any severe active acute or chronic infection 12. Severe cardiac dysfunction (NYHA grade III-IV) 13. Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent 14. Absence of caregivers in non-autonomous patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives are to better define the R2 efficacy and safety in terms of: - Complete Response Rate (CR), - Progression-Free Survival (PFS), - Overall Survival (OS), - Event-Free Survival (EFS), - Drop-out rate, - Rate of treatment discontinuation due to AE or treatment intolerance, - QoL assessement at baseline,4 months, 6 months and 12 months by EORTC-QLQ-C30 and FACT-Lym questionnaire. - Hematologic adverse events of any WHO grade (NCI CTCAE 4.03).;Main Objective: To evaluate the efficacy and the safety of the R2 (Lenalidomide + Rituximab) combination in first line DLBCL patients not candidate for the standard R-CHOP (or R-CHOP like) treatments due to frail status. The efficacy will be measured as overall response rate (ORR, defined as complete plus partial remission rate). The safety will be measured as rate of the extra-hematologic adverse events of WHO grade 3-4 (NCI CTCAE 4.03);Primary end point(s): Efficacy: overall response rate (ORR) Safety: clinical relevant toxicity, defined as the proportion of patients experiencing a grade 3 or greater non haematological toxicity. ;Timepoint(s) of evaluation of this end point: Efficacy: 48 months safety: 48 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Complete response rate (CR) ; Haematological toxicity of any WHO grade; Overall Survival (OS); Progression Free Survival (PFS); Event-Free Survival (EFS); Quality of Life (FACT-Lym and EORTC-QLQ-C39);Timepoint(s) of evaluation of this end point: 48 months; 48 months; 60months; 60 months; 60 months; 60 months | — |
Countries
Italy
Contacts
Public ContactUffici Studi FIL
Fondazione Italiana Linfomi Onlus
Outcome results
None listed