Histological proved diagnosis of B-cell CD20-positive non follicular NHL according to REAL/WHO Classification: a. small lymphocytic lymphoma b. lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia, c. nodal marginal zone lymphoma d. splenic marginal zone lymphomae. e. extranodal non-gastric marginal zone lymphoma MedDRA version: 9.1 Level: LLT Classification code 10029463 MedDRA version: 9.1 Level: LLT Classification code 10003911 MedDRA version: 9.1 Level: LLT Classification cod
Conditions
Interventions
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: LENALIDOMIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Trade Name: MABTHERA
Pha
Sponsors
G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histological proved diagnosis of B-cell CD20-positive non follicular NHL according to REAL/WHO Classification: a. small lymphocytic lymphoma b. lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia, c. nodal marginal zone lymphoma d. splenic marginal zone lymphomae e. extranodal non-gastric marginal zone lymphoma Tissue biopsy is mandatory when suspected pathological sites (nodal or extranodal) are easily accessible and in presence of extranodal non-gastric marginal or nodal marginal zone lymphoma diagnosis. In the other cases bone marrow biopsy, when representative, may be considered sufficient for defining lymphoma histotype. 2) Disease relapsing after >2, but less than 4 prior lines of (immuno)chemotherapy. At least one of previous treatment had to include rituximab 3) Presence of at least one of the following criteria for the definition of active disease: - systemic symptoms - bulky disease - progressive marrow failure and/or splenomegaly and/or lymph adenopathy 4) Age 18-75; 5) Life expectancy > 6 months; 6) ECOG performance status 0-2; 7) LVEF ³ 45%; 8) Creatinine clearance > 50 mL/min calculated by Cockcroft-Gault estimation; patients with creatinine clearance > 30 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Previously untreated patients; 2) Patients with diagnosis of typical Chronic Lymphocytic Leukemia (CLL); 3) Women and men not agreeing to take adequate contraceptive precautions during and for at least 4 weeks after cessation of therapy; 4) Pregnant or lactating women; 5) History of other malignancies within 3 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer, low grade, early stage localized prostate cancer treated surgically with curative intent, good prognosis DCIS of the breast treated with lumpectomy alone with curative intent; 6) Active bacterial, viral or fungal infection requiring systemic therapy; 7) Concurrent co-morbid medical condition which might exclude administration of therapy; 8) Cardiac insufficiency (NYHA grade III/IV); 9)Myocardial infarction within 6 months of entry on the study; 10) Severe chronic obstructive pulmonary disease with hypoxemia; 11) Severe diabetes mellitus difficult to control with adequate insulin therapy; 12)Hypertension that is difficult to control; 13) Creatinine clearance < 30 mL/min calculated by Cockcroft-Gault estimation; 14)ANC < 1 x 109/L, unless due to lymphoma involvement and not responding to 5 days of G-CFS treatment. 15)Platelets count < 75.000/mm3 unless due to lymphoma involvement 16) HIV and HBV positivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the antitumor activity of oral lenalidomide 20mg/day (dd1-21q28) when given in combination with rituximab in patients with indolent non follicular NHL Relapsed after >2, but less than 4 prior lines of (immuno)chemotherapy.- Efficacy will be evaluated in term of ORR (CR+PR) and tumour control rate (CR+PR+SD) measured at 26 weeks, four weeks after the last (VI) Rituximab infusion. - To asses to the safety of R-lenalidomide evaluated by standard criteria (CTC-NCI 3.0).;Secondary Objective: - To compare the efficacy of lenalidomide in combination with rituximab in term of duration remission with those obtained after previous line of treatment, when rituximab was utilized.- To evaluate progression free survival (PFS), event free survival (EFS), duration of remission (DR).- To correlate clinical and biological markers of antilymphoma activity of lenalidomide/rituximab combination with specific transcriptional profiles of responder or non responder patients, by means of oligonucleotide microarray DNA analysis;Primary end point(s): - To evaluate the antitumor activity of oral lenalidomide 20mg/day (dd1-21q28) when given in combination with rituximab in patients with indolent non follicular NHL Relapsed after >2, but less than 4 prior lines of (immuno)chemotherapy.- Efficacy will be evaluated in term of ORR (CR+PR) and tumour control rate (CR+PR+SD) measured at 26 weeks, four weeks after the last (VI) Rituximab infusion. - To asses to the safety of R-lenalidomide evaluated by standard criteria (CTC-NCI 3.0). | — |
Countries
Italy
Outcome results
None listed