Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent
Ability and willingness to comply with the requirements of the study protocol
Age ≥ 18 years
Documented history of histologically confirmed CD20-positive follicular NHL (Phases I and II); for Phase I, other CD20-positive indolent lymphomas (marginal zone lymphoma and small lymphocytic lymphoma) are also included. Patients with a history of a CD20-positive NHL of mixed (indolent/aggressive) histology may also be included in Phase I if the most recent relapse biopsy shows only indolent NHL
Indolent lymphoma (Phase I) or follicular lymphoma (Phase II) that either has relapsed after a documented history of response (CR, CRu, or PR) of ≥6 months to a rituximab-containing regimen or was refractory to a previous rituximab-containing regimen
Bi-dimensionally measurable disease, with at least one lesion \>1.5 cm in its largest dimension
Absolute B-cell count ≥LLN at screening (Phase I only)
ECOG performance status of 0, 1, or 2
For patients of reproductive potential (males and females), use of a reliable means of contraception during the study and for 1 year following the last dose of study treatment
For females of childbearing potential, a negative serum pregnancy test within 14 days prior to enrollment
You may not be if
Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab or radioimmunotherapy)
Prior use of any non-CD20-targeted monoclonal antibody therapy within 6 months of enrollment
Current or recent lymphoma treatment
History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
Evidence of myelodysplasia or myelodysplastic changes on bone marrow examination
Untreated or persistent/recurrent malignancy (other than lymphoma)
Known active bacterial, viral, fungal, mycobacterial, or other infection
A major episode of infection requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening or oral antimicrobials within 2 weeks of screening
History of recurrent significant infection or bacterial infections
Positive hepatitis B or C serology
Positive human immunodeficiency virus (HIV) serology
Pregnancy or lactation
Central nervous system lymphoma
Recent major surgery within 4 weeks of screening, other than diagnostic surgery
