Approved in relapsed CLL in combination with rituximab where rituximab alone is appropriate due to comorbidities
approval from a
pivotal phase 3 trial
- Patients received 8 doses of rituximab: first dose at 375 mg/m2, subsequent doses at 500 mg/m2 for weeks 2, 4, 6, 8, 12, 16, and 20
- Primary: progression-free survival as assessed by an independent review committee
First planned interim analysis
was at 50% of events
|Patients with CLL who relapsed within 24 months of their last therapy and required treatment1|
Unable to tolerate standard chemoimmunotherapy
|Prior therapies||≥1 anti-CD20–based regimen or ≥2 prior cytotoxic regimens|
*The CIRS score assesses a patient's comorbidity burden, with higher scores indicating an increased number or increased severity of coexisting illnesses.
CIRS=Cumulative Illness Rating Score; CLL=chronic lymphocytic leukemia; CrCl=creatinine clearance.
Median age (range), years
Rai stage 0/I-II/III-IV (%)
Median Karnofsky performance status
grade ≥1 (%)†
grade ≥1 (%)†
Prior regimens, median (range)
Most common prior regimens (>15%)
†Cytopenias were defined as blood cell counts below the lower limit of normal. Anemia was defined as a disorder characterized by a reduction in the amount of hemoglobin in 100 mL of blood. Neutropenia was defined as a finding based on laboratory tests that indicate a decrease in the number of neutrophils in the blood specimen. Thrombocytopenia was defined as a finding based on laboratory test results that indicate a decrease in the number of platelets in the blood specimen.5
BR=bendamustine, rituximab; Clb=chlorambucil; FCR=fludarabine, cyclophosphamide, rituximab; FR=fludarabine, rituximab; IGHV=immunoglobulin heavy-chain variable region; R=rituximab.