An Open-Label, Multicenter, Phase I/II Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Who Have Been Treated With a Purine Nucleoside Analogue-Containing Regimen
Inclusion Criteria:
- Documented history of histologically confirmed B-cell CLL
- Relapsed or refractory CLL with history of prior treatment with purine nucleoside
analogue-containing regimen
- Eligible for treatment of their CLL based on criteria adapted from the National
Cancer Institute-Working Group (NCI-WG) Response Criteria for CLL
- For patients of reproductive potential (males and females), use of a reliable means
of contraception
- For females of childbearing potential, a negative serum pregnancy test
Exclusion Criteria:
- Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab)
- Prior use of any non-CD20 targeted monoclonal antibody therapy within 6 months of
enrollment
- Current or recent CLL treatment
- History of severe allergic or anaphylactic reactions to human, humanized, chimeric,
or murine monoclonal antibodies
- Evidence of acute/active autoimmune hemolytic anemia or other autoimmune
complications of CLL
- Use of hematopoietic growth factors or RBC and/or platelet transfusions
- 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
- History of cancer other than CLL)
- Known active bacterial, viral, fungal, mycobacterial, or other infection or any major
episode of infection requiring hospitalization or treatment with IV antibiotics or
oral antibiotics
- 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
- Positive hepatitis B or C serology
- Positive human immunodeficiency virus (HIV) serology
- Active cytomegalovirus (CMV) disease by antigen or polymerase chain reaction testing
- Pregnancy or lactation
- CNS leukemia
- Recent major surgery, other than diagnostic surgery