Extended Follow up of a Phase 2 Study of Early Intervention with Lenalidomide in Patients with High-Risk Chronic Lymphocytic Leukemia

• Published in: Blood 2023-11, Vol.142 (Supplement 1), p.3272-3272
• Main Authors: Rogers, Kerry A, Zhao, Qiuhong, Bhat, Seema A, Byrd, John C., Grantier, Cara, Grever, Michael R., Hoffman, Corinne, Kittai, Adam S, Lozanski, Gerard, Lucas, Margaret S., Rike, Lindsey, Thangavadivel, Shanmugapriya, Carson III, William E., Woyach, Jennifer A.
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2023-180308

Lenalidomide (LEN) is an effective therapy for chronic lymphocytic leukemia (CLL) and has immunomodulatory effects that were hypothesized to improve immune function in patients (pts) with untreated early stage CLL. A NCI/CTEP sponsored phase 2 study (NCT01351896) randomized asymptomatic pts with high-risk CLL to receive LEN either concurrent with or delayed from (3 months after 1st dose) two doses of 13-valent protein-conjugated pneumococcal vaccine (PCV13). The primary endpoint was the proportion of pts who achieve an antibody response to the 2nd PCV13 vaccine and was not significantly different between groups (Thangavadivel et al., Clinical Cancer Research 2020). Despite this, many pts experienced effective CLL disease control with LEN. Here we report long-term results from this trial to examine the impact of LEN early treatment on CLL disease course, complicating infections (INF), and second neoplasms (SN). Pts ≥18 and