This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with chronic lymphocytic leukemia (CLL) who have relapsed after or were refractory to treatment with a purine nucleoside analogue-containing regimen. The trial will enroll in two phases: a Phase I dose-escalation portion and a Phase II expanded treatment cohort, with enrollment of additional patients in order to expand safety experience and collect preliminary anti-leukemia activity data.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Escalating doses by IV infusion
Dose-limiting toxicities and adverse events
Time frame: Length of study
Pharmacokinetic parameters; CD19-positive B-cell counts
Time frame: Length of study
Overall response rate and progression-free survival (Phase II only)
Time frame: Length of study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.