Dr. Smith on the Patient Population of the ECOG-ACRIN E1411 Trial in MCL

Mitchell R. Smith, MD, PhD, associate cancer center director for clinical investigations, chief, Division of Oncology and Blood Disorders, GW Cancer Center, clinical professor of medicine, GW School of Medicine and Health Sciences, discusses the patient population of the phase 2 of theECOG-ACRIN E1411 trial (NCT01415752) in mantle cell lymphoma (MCL).

The ECOG-ACRIN E1411 trial randomized patients with untreated MCL to the combination of bendamustine and rituximab (Rituxan; BR) followed by rituximab consolidation, BR plus bortezomib (Velcade; BVR) followed by rituximab consolidation, BR followed by lenalidomide (Revlimid) and rituximab (R2) consolidation, or BVR followed by R2.

Historically, clinical trials evaluating intensive frontline regimens excluded older patients with MCL because patients often received autologous stem cell transplant as consolidation, Smith says. In the ECOG-ACRIN E1411 trial, patients of all ages were eligible for enrollment, Smith explains. 

Thirteen percent of patients enrolled were under 60 years old, which translated to a median patient age of 67 years, Smith says. These patients had previously untreated MCL and adequate organ function, Smith adds. However, patients with low blood counts were eligible for enrollment because MCL can cause low counts, Smith explains. 

No other significant exclusion criteria were included in the trial; however, patients with known disease in the central nervous system were ineligible for enrollment, Smith adds. In turn, the study evaluated the utility of induction and consolidation therapy in a broad patient population, concludes.