Brief induction chemoimmunotherapy with Rituximab + Bendamustine + Mitoxantrone followed by Rituximab in elderly patients with advanced stage previously untreated follicular lymphoma - IILFLE09

• Conditions: Elderly patients with advanced stage previously untreated follicular lymphoma; MedDRA version: 14.1Level: HLTClassification code 10016903Term: Follicle centre lymphomas, follicular grade I, II, IIISystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2009-012337-29-IT
• Lead Sponsor: FONDAZIONE ITALIANA LINFOMI ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-09
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

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

Inclusion Criteria

1. Histological proven diagnosis of B-cell CD20+ follicular NHL, grade I, II and IIIa of WHO Classification 2. Untreated patients with the exception of prior limited radiotherapy 3. Stage III or IV who require therapy according to SIE and GELF criteria (see Appendix A) 4. Stage II with at least one of the following: a. Bulky disease (>7 cm) b. LDH >normal c. Systemic symptoms d. Beta2-Microglobulin >3 mg/l e. Extra-nodal involvement f. 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 10^9/l and Platelets count ≥75 x 10^9/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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

Exclusion Criteria

1. Men not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy 2. 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 3. Medical condition requiring long term use (>1 months) of systemic corticosteroids 4. Active bacterial, viral, or fungal infection requiring systemic therapy 5. Concurrent medical condition which might exclude administration of therapy 6. Cardiac insufficiency (NYHA grade III/IV; see Appendix D) 7. Myocardial infarction within 6 months of entry on study 8. Severe chronic obstructive pulmonary disease with hypoxemia 9. Severe diabetes mellitus difficult to control with adequate insulin therapy 10. Hypertension that is difficult to control 11. Impaired renal function with creatinine clearance <30 ml/min (see Appendix E) 12. HIV positivity 13. HBV positivity with the exception of patients HbsAg negative and Ab anti-Hbcore positive (these patients need to receive prophylaxis with Lamivudine) 14. HCV positivity with the exception of patients with no laboratory signs of active chronic hepatitis and HCV-RNA negativity 15. CNS involvement by lymphoma 16. Participation at the same time in another study in which investigational drugs are used 17. Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins 18. Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

Study & Design

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