Randomized controlled trial of individualized, low dose, fixed duration lenalidomide maintenance versus observation after frontline chemo-immunotherapy in CLL

Abstract

Lenalidomide maintenance after frontline chemo-immunotherapy (CIT) in chronic lymphocytic leukemia (CLL) has not been standard due to the availability of novel therapies, though these remain out of reach for most in low-middle income countries. This single-center, open-label study randomized CLL patients (non-deletion 17p) after frontline therapy to lenalidomide maintenance (dose-escalated 2.5–10mg, 20/28 days per cycle for six months) or observation (2:1 allocation). Forty patients were included over 2018–2020. At a median follow-up of 22 months, median progression-free survival (PFS) with lenalidomide was not significantly different than observation (26 vs. 18 months, p = 0.4). Patients with minimal residual disease >10⁻² had a trend toward better PFS with lenalidomide (19 vs. 7 months, p = 0.07). Grade 3 neutropenia was seen in 16.7% of patients on lenalidomide. Quality of life was comparable between the two arms. Low dose, fixed duration lenalidomide maintenance is not an effective strategy after frontline CIT in CLL.

Keywords:

• CLL
• RCT
• lenalidomide

Acknowledgments

The authors thank the European Hematology Association Clinical Research Training in Hematology (EHA-CRTH) team for developing the clinical trial protocol.

Support

The study drug lenalidomide was provided free of cost by Dr. Reddy's Laboratories, Hyderabad, India. However, the company was not involved in designing the study, data collection, analysis, and writing the manuscript in any form.

Author contributions

NJ, DL, and PM were involved in study conception and design. All authors contributed to patient care. Data was collected, analyzed, and draft manuscript written by NJ, DL, and PM. All authors revised the manuscript and approved the final version. DPL and NJ had full access to all the data in the study and the final responsibility to submit the paper for publication.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

Part of this work was funded by the Postgraduate Institute of Medical Education and Research intramural grant 71/2-Edu-16/190 to DL.