non-Hodgkin lymphoma
Conditions
Interventions
Obinutuzumab will be administered intravenously at a flat dose of 1000 mg on
Day 1, 8 and 15 during Cycle 1, and on Day 1 of subsequent cycles.
Following induction obinutuzumab plus chemotherapy, ma
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age > 18 years, - Able and willing to comply with all study related procedures including completion of patient-reported outcome endpoints, - Ability to comply with the study protocol, in the investigator's judgment, - Patients with previously untreated Stage III or IV FL or Stage II bulky disease scheduled to receive obinutuzumab plus chemotherapy due to at least one of the following criteria:, o Bulky disease, o Local symptoms or compromise of normal organ function due to progressive nodal disease or extranodal tumor mass, o Presence of B symptoms, o Presence of symptomatic extra nodal disease, o Cytopenias due to underlying lymphoma, o Involvement of 3 nodal sites, each with a diameter of 3 cm, o Symptomatic splenic enlargement, - Histologically documented CD-20-positive FL, as determined by the local laboratory, See protocol for other criteria
Exclusion criteria
Exclusion criteria: - Relapsed / refractory FL, - Prior treatment for FL with chemotherapy, radiotherapy or immunotherapy, - Grade IIIb FL, - Histological evidence of transformation of FL into high-grade B-cell NHL, - Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone/prednisolone (at a dose equivalent to >30 mg/day prednisone), methylprednisolon, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1, - History of solid organ transplantation and anti-CD20 antibody therapy, See protocol for other criteria *
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to evaluate the safety of obinutuzumab administered as an SDI during cycle 2 and from cycle 2 onwards in patients with previously untreated advanced FL on the basis of the following endpoints: The incidence of Grade >= 3 IRRs* (with severity determined according to NCI CTCAE Version 5.0 during the first SDI cycle: - cycle 2 in patients who received obinutuzamab at the standard infusion rate without experiencing a Grade 3 IRR in cycle 1 - cycle 3 in patients who experienced a Grade 3 IRR when administered obinuzutumab at the standard infusion rate in cycle 1 and subsequently received obinutuzamab at the standard infusion rate in cycle 2 without experiencing a Grade 3 IRR. IRRs are defined as all adverse events (AEs) that occur during or within 24 hours from the end of study treatment infusion and are judged as related to infusion of study treatment components (obinutuzumab and chemotherapy during induction and obinutuzumab alone during maintenance) by the investigator. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence, nature, and severity of all AEs during cycle 1 and from cycle 1 onwards (including maintenance) • Incidence of IRRs regardless of grade by cycle (separately) • Time to IRR (in hours) from infusion to onset of the IRR during cycle 2 • Duration (in minutes) of obinutuzumab administration by cycle (all cycles including maintenance) • Type and duration of Grade >=3 IRRs associated with the obinutuzumab administered as an SDI by cycle. For more information about outcomes see paragraph 2.2 and 2.3 in the protocol | — |
Countries
Netherlands
Outcome results
None listed