Previously untreated intermediate-high risk according to the FLIPI2 stage II-IV follicular lymphoma requiring therapeutic intervention. MedDRA version: 14.1 Level: PT Classification code 10061170 Term: Follicle centre lymphoma, follicular grade I, II, III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ZEVALIN*INFUS 1F 2ML 1,6MG/ML
Pharmaceutical Form: Injection
INN or Proposed INN: YTTRIUM (90Y) IBRITUMOMAB TIUXETAN
CAS Number: 174722-31-7
Concentration unit: mCi/kg millicurie(s)/kilogr
Sponsors
FONDAZIONE ITALIANA LINFOMI ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 202
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether a PET and MRD response-based maintenance therapy is more effective in terms of Progression-Free Survival (PFS) than a standard maintenance therapy with Rituximab in patients with untreated, advanced, follicular lymphoma.;Secondary Objective: To evaluate the efficacy of maintenance with observation or pre-emptive Rituximab therapy administered on the basis of MRD status and the efficacy of a standard maintenance for 2 years in patients at low risk of progression after induction chemoimmunotherapy. To evaluate the efficacy of intensified maintenance with (90)Y Ibritumomab Tiuxetan followed by Rituximab maintenance therapy and the efficacy of a standard maintenance for 2 years in patients at high risk of progression after induction chemoimmunotherapy. To compare a response-based maintenance therapy with a standard maintenance therapy in terms of toxicity. To verify the predictive value of MRD detection. To perform a cross evaluation of the predictive value of MRD analysis and FDG-PET.;Primary end point(s): Progression free survival (PFS) defined as the time from entry onto the study until lymphoma progression or death as a result of any cause.;Timepoint(s) of evaluation of this end point: the time from entry onto the study until lymphoma progression or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): overall survival (OS), overall response rate (ORR), duration of remission (DR) and event free survival (EFS). Molecular response evaluated by PCR assessment of Bcl2/IgH rearrangement;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Italy
Contacts
Public ContactSegreteria Amminstrativa
Fondazione Italiana Linfomi ONLUS
Outcome results
None listed