None listed
Conditions
Interventions
Stage 1: Cohort A Type of group
Rituximab intravenous infusion 375 milligram per square meter (mg/m^2) administered every 2 or 3 months.
Group name:Stage 2: Cohort F Type of group
Rituximab subcutaneous injection at 1400 mg dose level, administered every 2 or 3 months.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Informed consent in writing and ability and willingness to comply with the visitation program and with the evaluations required by the protocol. • Age> 18 years • A lymph node biopsy should be performed before starting induction treatment to histologically confirm follicular NHL CD20 positive grade 1.2 or 3a, according to the WHO classification system, which requires treatment. • Patients treated with rituximab (375 mg / m ^), and who responded to treatment; that is, patients must have achieved a documented PR or CR at the end of induction treatment (according to Annex 6). • Patients must have finished induction therapy and must have received at least one dose of maintenance therapy with rituximab IV. The minimum induction therapy required is 4 cycles of rituximab with any number of chemotherapy cycles. • Patients should start maintenance therapy with rituximab 6 months. • Negative serum pregnancy test at baseline, before treatment for premenopausal women and for women whose onset of menopause occurred <2 years ago, or within a period of 14 days with a confirmatory pregnancy test in urinate a week before starting the study treatment.
Exclusion criteria
Exclusion criteria: • Histological evidence of transformation of NHL or types of NHL other than FL according to the WHO classification. • Women who are pregnant or breastfeeding. • Men or women of childbearing age, unless they are surgically sterile or use an appropriate contraceptive method, such as oral contraceptives, intrauterine device, or contraceptive barrier method along with spermicidal gel. Effective contraceptives are required throughout the study and at least 12 months after the last dose of rituximab. • History of central nervous system disease (CNS lymphoma or lymphomatous meningitis). • Any abnormal laboratory value • Seropositivity for Hepatitis B virus (unless it is evident that it is due to vaccination). • Known HIV infection. • Known infection of a bacterial, viral, fungal, mycobacterial or other type of infection (excluding fungal infections of the nail bed), or any major episode of infection that requires hospitalization or treatment with IV antibiotics within 4 weeks of selection, or oral antibiotics within 2 weeks prior to selection. • History of malignant diseases other than follicular NHL that may affect compliance with the protocol or the interpretation of the results. Patients with a history of squamous or basal cell carcinoma, or carcinoma in situ of the cervix, who received treatment and were cured, are generally eligible. • Recent major surgery (within 4 weeks prior to selection), excluding lymph node biopsy. • History of organ transplants. • Evidence of significant and concomitant uncontrolled diseases, which could affect compliance with the protocol or the interpretation of the results, including significant cardiovascular disease (such as heart disease class III or IV according to the New York Heart Association, heart attack myocardium within the last 6 months, unstable arrhythmias or unstable angina) or lung disease (including obstructive pulmonary disease and a history of symptomatic bronchospasm). • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, other than rituximab. Known sensitivity or allergy to murine products. Known hypersensitivity to any of the study drugs or their ingredients (i.e., hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human antibodies). • Ongoing or recent treatment (within 30 days prior to the start of the selection) with another investigational drug or participation in another therapeutic research study. • Evidence of any other coexisting disease or medical or psychological condition, metabolic dysfunction, physical examination finding, or clinical laboratory finding that constitutes a reasonable suspicion of a disease or condition that constitutes a contraindication for the use of a research drug, or a patient at high risk of treatment complications or who could compromise their ability to grant informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Through laboratory evaluations to determine the levels of human anti-chimeric antibodies Measure:Minimum Observed Plasma Trough Concentration (C trough) Timepoints:Up to 29 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Through laboratory evaluations to determine the levels of human anti-chimeric antibodies Measure:Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau) Timepoints:Up to 29 months ; Outcome name:Through laboratory evaluations to determine the levels of human anti-chimeric antibodies Measure:Maximum Observed Plasma Concentration (Cmax) Timepoints:Up to 29 months ; Outcome name:Through laboratory evaluations to determine the levels of human anti-chimeric antibodies Measure:Time to Reach Maximum Observed Plasma Concentration (Tmax) Timepoints:Up to 29 months ; Outcome name:Through laboratory evaluations to determine the levels of human anti-chimeric antibodies Measure:Plasma Decay Half-Life (t1/2) Timepoints:Up to 29 months ; Outcome name:Through laboratory evaluations to determine the levels of human anti-chimeric antibodies Measure:Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) Timepoints:Up to 29 months | — |
Countries
Argentina, Australia, Brazil, Canada, Czech Republic, Denmark, Ecuador, Finland, France, Israel, Italy, Korea South, Mexico, Norway, Poland, Russian Federation, Slovakia, Spain, Sweden, Switzerland, United Kindgdom
Contacts
Public ContactANIBAL ENRIQUE SALAS
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed