First-line / Newly Diagnosed · Phase II component of randomized phase II/III; N=73 newly diagnosed double-hit lymphoma. DA-EPOCH-R vs DA-EPOCH-R+venetoclax. Primary endpoint PFS. · Median PFS 28.4 vs 7.7 months

ALLIANCE A051701

Clinical question: Does adding venetoclax to DA-EPOCH-R improve PFS and OS in newly diagnosed double-hit lymphoma?

Median PFS 28.4 vs 7.7 months; HR 1.13 (95% CI 0.53–2.37; P=0.75). 24-month OS 72% vs 52%; HR 2.49 (95% CI 1.03–6.04; P=0.038), favouring DA-EPOCH-R alone. · Registry:

Design, population and treatment

Phase II component of randomized phase II/III; N=73 newly diagnosed double-hit lymphoma. DA-EPOCH-R vs DA-EPOCH-R+venetoclax. Primary endpoint PFS.

Key efficacy outcome

52 · intervention

52 · comparator

No NNT: experimental addition did not improve PFS and was associated with excess mortality; descriptive NNH 5 for 24-month OS decrement in this small cohort.

Six on-treatment deaths (17%) with venetoclax vs one (3%) with DA-EPOCH-R; cohort closed early for excess mortality. Grade 3–4 febrile neutropenia 43% vs 37%.

Safety and absolute effect

24-month OS (%)

https://pmc.ncbi.nlm.nih.gov/articles/PMC13730458/

Interpretation and limitations

Current-practice context · 14 November 2026: Primary publication/abstract and trial identifier checked. Guideline-level current-practice mapping was not established in this publication-led batch; no NCCN citation provenance is claimed. Where detailed QoL, follow-up or toxicity data were not present in the retrieved abstract, they are not inferred.

Primary source

Primary publication · DOI: 10.1016/S2352-3026(26)00191-2