PHASE II STUDY OF LENALIDOMIDE IN COMBINATION WITH RITUXIMAB (R) FOR THE TREATMENT OF INDOLENT NON FOLLICULAR NON HODGKIN LYMPHOMA - ND

Phase 1

• Conditions: 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: 9.1Level: LLTClassification code 10029463; MedDRA version: 9.1Level: LLTClassification code 10003911; MedDRA version: 9.1Level: LLTClassification code 10041652; MedDRA version: 9.1Level: LLTClassification code 10025345

• Registration Number: EUCTR2008-001591-80-IT
• Lead Sponsor: G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-22
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 < 50 mL/min, at physician discretion could enter in the study starting at lenalidomide dose level -2 (10 mg ); 9) Total bilirubin up to 2 x ULN. Total bilirubin values higher than 2 x ULN are admitted if related to localization of the disease; 10) Alkaline phosphatase up to 2 x ULN and transaminases up to 3 x ULN; 11) Female and male patients must agree to participate in pregnancy prevention program signed informed Consent 12) Written informed Consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified