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Trial result

SAVE: Obinutuzumab + venetoclax (BCL-2 inhibitor) compresses the 5-week ramp-up to 7 inpatient days with 0 clinical TLS

Trial ID
NCT04843904 on ClinicalTrials.gov
Cancer type
Chronic Lymphocytic Leukemia and Small Cell Lymphoma (B-cell CLL, SLL)
Published in
New in Oncology - Aug 6, 2026

In the Phase Ib SAVE study (NCT04843904), venetoclax (VEN), an oral BCL-2 inhibitor, was initiated with an accelerated daily inpatient ramp-up (20→400mg) in CLL, almost universally combined with the anti-CD20 antibody obinutuzumab. Forty patients were treated (n=40), including 37.5% relapsed/refractory and 32.5% medium/high baseline TLS risk; there were no clinical TLS events and 1/40 (2.5%) lab TLS (high-risk, BTKi-refractory) after the 200mg step that resolved within 1 day with a 1-day hold/supportive care, with median inpatient stay 7 days. At 3 months (intent-to-treat), ORR was 78%—roughly in the same ballpark as the fixed-duration venetoclax–obinutuzumab frontline benchmark where overall response is typically ~85%, but SAVE’s key value proposition is operational (faster initiation) rather than clearly superior efficacy from these early, small, mixed-line data.

Take home

If broader, real-world replication holds up, a 7-day monitored ramp could materially reduce the friction of starting venetoclax for appropriately selected patients—though centers will want more granular TLS/renal outcomes (and outpatient feasibility) before rewriting the playbook.

Source: Read the original publication

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