Brief Chemoimmunotherapy With R+B+M Followed by R in Elderly Patients Advanced Stage Untreated Follicular Lymphoma

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a brief chemoimmunotherapy with the combination of Rituximab + Bendamustine + Mitoxantrone in elderly patients with advanced stage Follicular Lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Italiana Linfomi ONLUS
• Collaborator: Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
• Treatments: Bendamustine Hydrochloride; Mitoxantrone; Rituximab

Criteria

Inclusion Criteria:

• Histological proven diagnosis of B-cell CD20+ follicular NHL, grade I, II and IIIa of WHO Classification

• Untreated patients with the exception of prior limited radiotherapy

• Stage III or IV who require therapy according to SIE and GELF criteria

• Stage II with at least one of the following:

• Bulky disease (>7 cm)

• LDH >normal

• Systemic symptoms

• Beta2-Microglobulin >3 mg/l

• Extra-nodal involvement

• Active disease with rapid progression 5.Age from 65 to 80 years, geriatric score "FIT" (see Appendix B) 6.Life expectancy >6 months 7.ECOG performance status 0-2 (see Appendix C) 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.Sending of bone marrow sample for Bcl-2/IgH rearrangement evaluation 14.Written informed content

Exclusion Criteria:

• Men not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy

• 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

• Medical condition requiring long term use (>1 months) of systemic corticosteroids

• Active bacterial, viral, or fungal infection requiring systemic therapy 5. Concurrent medical condition which might exclude administration of therapy

• Cardiac insufficiency (NYHA grade III/IV; see Appendix D)

• Myocardial infarction within 6 months of entry on study

• Severe chronic obstructive pulmonary disease with hypoxemia

• Severe diabetes mellitus difficult to control with adequate insulin therapy

• Hypertension that is difficult to control

• Impaired renal function with creatinine clearance <30 ml/min (see Appendix E)

• HIV positivity

• HBV positivity with the exception of patients HbsAg negative and Ab anti-Hbcore positive (these patients need to receive prophylaxis with Lamivudine)

• HCV positivity with the exception of patients with no laboratory signs of active chronic hepatitis and HCV-RNA negativity

• CNS involvement by lymphoma 16. Participation at the same time in another study in which investigational drugs are used

• Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins

• Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent