a trial of the safety of escalating doses of pro131921 in patients with relapsed or refractory indolent non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

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.


Eligibility 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

Keywords: nhl indolent follicular