A multicenter, phase III, randomized study to evaluate the efficacy of a response-adapted strategy to define maintenance after standard chemoimmunotherapy in patients with advanced-stage Follicular Lymphoma

Conditions: Previously untreated intermediate-high risk according to the FLIPI2 stage II-IV follicular lymphoma requiring therapeutic intervention.
MedDRA version: 14.1Level: PTClassification code 10061170Term: Follicle centre lymphoma, follicular grade I, II, IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2012-003170-60-IT

Lead Sponsor: FONDAZIONE ITALIANA LINFOMI ONLUS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• Histological diagnosis of B-Cell CD20+ Follicular Lymphoma (FL), grade I, II, IIIa according to the WHO 2008 classification • ECOG performance status 0-2 • Age = 18 years • Ann Arbor stage II-IV • FLIPI2>0 • Presence of evaluable/measurable disease after diagnostic biopsy • At least one of the following criteria for defining active disease: - systemic symptoms - cytopenia due to bone marrow involvement - LDH> upper normal value - any nodal or extranodal tumor mass with a diameter >7cm - involvement of = 3 nodal sites, each with a diameter of = 3cm - extranodal disease - rapidly progressive disease • Life expectancy > 6 months • Left ventricular ejection fraction (LVEF) ? 50% • Serum negativity for HIV • Serum negativity for HBsAg; HBcAb positive but HBV-DNA negative patients are allowed with mandatory Lamivudine prophylaxis. • Serum negativity for HCV, except for those patients without signs of active viral replication assessed by HCV-RNA copies • Serum creatinine < 2mg/dl , serum bilirubin < 1.5mg/dl, aspartate amino-transferase (AST/GOT) ? 2.5xUNV, alanine amino-transferase (ALT/GPT) ? 2.5xUNV, and alkaline phosphatase ? 4 times the upper limit of normal (unless the increase is attributed directly to the presence of tumour by the Investigator) • Patients with no previous treatment for the lymphoma with the exception of locoregional radiotherapy (IF-RT) • Adequate measure adoption to avoid pregnancy • Written informed consent given at time of registration • Patient must be accessible for treatment and follow up
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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 202

Exclusion Criteria

• Histological diagnosis of : -any lymphoma other than follicular lymphoma and all CD20 negative B-cell lymphomas -grade III b follicular lymphoma -evidence of transformation to high grade lymphoma • Ann Arbor stage I • Suspect or clinical evidence of CNS involvement by lymphoma • History of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or 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 • Evidence of any severe active acute or chronic infection • Concurrent co-morbid medical condition which might exclude administration of full dose chemotherapy • Severe chronic obstructive pulmonary disease with hypoxemia • Severe diabetes mellitus difficult to control with adequate insulin therapy • Myocardial infarction within 6 months before study entry • Clinically significant secondary cardiovascular disease e.g. uncontrolled hypertension, (resting diastolic blood pressure >115 mmHg), uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA class III-IV • HbsAg-positive, HIV-positive, or HCVAb-positive patients • 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 • Follicular lymphoma, showing a negative baseline PET scan