Stage I/II Follicular Lymphoma
Conditions
Interventions
Trade Name: ARZERRA
Product Name: OFATUMUMAB
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
FONDAZIONE ITALIANA LINFOMI ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed follicular lymphoma grade I-IIIa; • Stage IA or IIA (no more than 2 contiguous nodal regions) non bulky (=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: • Follicular lymphoma grade IIIb; • Stage greater than II with more than 2 nodal sites and/or B symptoms and/or bulky disease (>7 cm); • FLIPI >2, FLIPI2 >2; • Age 2.0 times upper normal limit; total bilirubin >1.5 times upper normal limit; ALT >2.5 times upper normal limit; alkaline phosphatase >2.5 times upper normal limit. • Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at screening. Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence • Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the proportion of patients obtaining disappearance of Bcl-2-IgH rearranged cells in peripheral blood and/or bone marrow by PCR, after treatment with Ofatumumab. ;Secondary Objective: To evaluate clinical response rate, relapse-free survival (RFS) and progression-free survival (PFS) in patients treated with local radiotherapy and molecularly–based Ofatumumab consolidation and/or retreatment; these objectives will be defined by clinical and instrumental procedures, according to Cheson criteria. To evaluate the role of quantitative PCR determination of basal Bcl-2-IgH rearranged cells in PB and BM in predicting the probability of negativization after local radiotherapy and the probability of relapse. ;Primary end point(s): The proportion of Bcl-2 negativization after Ofatumumab treatment will be estimated by the proportion, and its confidence interval, of residual Bcl-2 positive cases after radiotherapy, which will became negative after Ofatumumab treatment.;Timepoint(s) of evaluation of this end point: 30 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical response rate will be evaluated by the proportion and its confidence interval of patients achieving overall response (OR) complete response (CR) and partial response (PR). Progression Free Survival (PFS) is defined as the length of time between the date of treatment conclusion and the earliest date of disease progression or death due to any cause; If the patients doesn’t not have a documented date of progression or death, the PFS will be censored at the date of last adequate assessment. Relapse Free Survival (RFS) is defined as the length of time between the achievement of Complete Remission (CR) and Relapse of disease RFS and PFS in patients treated with local radiotherapy and molecularly–based Ofatumumab consolidation and/or retreatment will be evaluated by Kaplan-Meier survival analysis.;Timepoint(s) of evaluation of this end point: 72 months | — |
Countries
Italy
Contacts
Public ContactSECRETARY
FONDAZIONE ITALIANA LINFOMI ONLUS
Outcome results
None listed