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Clinical Trial Summary

This open-label, multicenter, randomized study will compare the efficacy, safety and pharmacokinetics of RO5072759 (GA101) 1000 mg versus 2000 mg in patients with previously untreated chronic lymphocytic leukemia. The randomization scheme will ensure approximately equal sample sizes in the two treatment dose arms for the following stratification factors: 1) tumor burden at baseline (high or low); and 2) Rai stage at baseline (study entry; I/II or III/IV). Tumor burden will be assessed on the basis of the presence or absence of at least one nodal mass >/= 5 cm in the baseline computed tomography (CT) scan. Patients will be randomized to receive a maximum of 8 cycles of GA101: 1000mg intravenous (iv) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8 on 21 day cycles or maximum of 8 cycles of GA101 2000mg iv infusion, on days 1 (split dose 100 mg on Day 1, 900 mg on Day 2, 1000 mg on Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8 on 21 day cycles.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01414205
Study type Interventional
Source Genentech, Inc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date October 2011
Completion date March 2016

See also
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