A Phase II study of Bendamustine in Combination With Rituximab as Initial Treatment for Patients With Indolent non-follicular Non-Hodgkin’s Lymphoma

• Conditions: Patients with advanced untreated Indolent non Follicular non-Hodgkin Lymphomas; MedDRA version: 14.1Level: PTClassification code 10065856Term: Non-Hodgkin's lymphoma unspecified histology indolentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2010-019248-37-IT
• Lead Sponsor: FONDAZIONE ITALIANA LINFOMI ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-20
• Last Update Posted: 28 December 2015

Recruitment & Eligibility

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

Inclusion Criteria

1) Understand and voluntarily sign an informed consent form 2) Histological (bone marrow or lymph nodes biopsy) proven diagnosis of B-cell CD20- positive non-follicular NHL according to REAL/WHO Classification: i. small lymphocytic lymphoma-SLL (bone marrow or lymph nodes biopsy) ii. lymphoplasmacytic/citoid lymphoma/ Waldenstrom macroglobulinemia (bone marrow or lymph nodes biopsy) iii. nodal marginal zone lymphoma (lymph nodes biopsy) 3) Untreated patients 4) Stage III or IV or stage II with more than three involved sites 5) Presence of at least one of the following criteria for the definition of active disease a. Systemic symptoms b. Hemoglobin less than 10 g/dL (due to lymphoma) c. Platelets less than 100 x 109/L (due to lymphoma) d. Diffuse bone marrow infiltrate e. Lymphocyte doubling time less than 12 months (in leukemic cases) f. Bulky disease (>7 cm) 6) Aged 18 - 75 Life expectancy >6 months 7) ECOG performance status 0-2 8) LVEF =45% or FS =37% 9) ANC =1 x 109/l and Platelets count =75 x 109/l, unless due to bone marrow involvement by follicular lymphoma 10) Creatinine up to 1.5 x ULN 11) Conjugated bilirubin up to 2 x ULN 12) Alkaline phosphatase and transaminases up to 2 x ULN 13) Written informed content
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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. Patients with diagnosis of marginal zone lymphoma of splenic or MALT origin 2. Patients with diagnosis of typical Chronic Lymphocytic Leukemia (CLL) 3. Men not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy 4. History of other malignancies within 3 years prior to study entry except for: adequately treated carcinoma in situ of the cervix; 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 5. Medical condition requiring long term use (>1 months) of systemic corticosteroids 6. Active bacterial, viral, or fungal infection requiring systemic therapy 7. Concurrent medical condition which might exclude administration of therapy 8. Cardiac insufficiency (NYHA grade III/IV) 9. Myocardial infarction within 6 months of entry on 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. Impaired renal function with creatinine clearance <30 ml/min 14. HIV positivity 15. HBV positivity with the exception of patients HbsAg negative and Ab anti-Hbcore positive (these patientes need to receive prophylaxis with Lamivudine) 16. HCV positivity with the exception of patients with HCV RNA negative. 17. CNS involvement by lymphoma 18. Participation at the same time in another study in with investiogational drugs are used 19. Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins 20. Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent 21. Women in pregnancy or breastfeeding

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the overall response rate (CR+PR) obtained with Bendamustine in combination with Rituximab in previously untreated INFL.;Secondary Objective: • To evaluate the safety of Bendamustine in combination with Rituximab in previous untreated INFL • To evaluate the overall survival (OS) • To evaluate the progression-free survival (PFS) • To evaluate the disease –free survival (DFS);Primary end point(s): Overall response rate and complete remission rate