Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fondazione Italiana Linfomi - ETS
With
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Age
65–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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