Status:
COMPLETED
Brief Chemoimmunotherapy With R+B+M Followed by R in Elderly Patients Advanced Stage Untreated Follicular Lymphoma
Lead Sponsor:
Fondazione Italiana Linfomi - ETS
Collaborating Sponsors:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
65-80 years
Phase:
PHASE2
Brief 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 pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01523860
Start Date
June 1 2009
End Date
January 1 2015
Last Update
March 1 2016
Active Locations (37)
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1
Divisione di Ematologia Ospedale SS. Antonio e Biagio
Alessandria, Alessandria, Italy, 15100
2
SOS Ematologia Ospedale C. Massaia
Asti, Asti, Italy, 14100
3
Ematologia con Trapianto, Università di Bari
Bari, Bari, Italy, 70124
4
Medicina Interna, Ospedale degli Infermi
Biella, Biella, Italy, 13800