Status:
TERMINATED
A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
Lead Sponsor:
Genentech, Inc.
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 enro...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00452127
Start Date
May 1 2007
Last Update
January 28 2013
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