Non-Hodgkin's Lymphoma
Conditions
Keywords
NHL, Indolent, Follicular
Brief summary
This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with relapsed or refractory CD20-positive indolent NHL. The trial will enroll in two phases: a Phase I dose-escalation portion for patients with indolent NHL and a Phase II portion with enrollment of additional patients with follicular NHL into two expanded treatment cohorts in order to expand the safety database and collect preliminary anti-lymphoma activity data.
Interventions
DRUGPRO131921
Escalating doses by IV infusion
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicities and adverse events | Length of study |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; CD19-positive B-cell counts | Length of study |
| Overall response; and progression-free survival (Ph. 2 only) | Length of study |
Outcome results
None listed