Dr. Philips on the Design of a Phase 1 Trial With Venetoclax/Lenalidomide/Rituximab in MCL

Tycel Jovelle Phillips, MD, a clinical associate professor, Division of Hematology and Oncology, Department of Internal Medicine at Rogel Cancer Center, Michigan Medicine, discusses the design of a phase 1 trial (NCT03523975) with venetoclax (Venclexta), lenalidomide (Revlimid), and rituximab (Rituxan) in mantle cell lymphoma (MCL).

When designing the study, the goal was not to cherry pick patients, which led to investigators opening the trial to broad enrollment, according to Philips. The goal was to utilize the study regimen in the same manner cytotoxic chemotherapy might be used. All patients who were newly diagnosed continued to be eligible for enrollment on the trial, regardless of transplant eligibility, Philips explains. Additionally, patients were not excluded due to high-risk features or cytogenetic abnormalities.

The study was originally designed to treat patients with a 12-month induction of venetoclax, lenalidomide, and rituximab. Venetoclax was started on day 8, but patients were escalated by 50 mg weekly until they reached the maximum dose of 400 mg. The trial featured a prolonged dose-limiting toxicity period of 42 days due to the escalation. Thereafter, response assessments were planned to occur every 3 months through radiographs and minimal residual disease testing, Philips concludes.