Open-Label Study of Lenalidomide in Combination With Oral Dexamethasone in the Treatment of Previously Untreated, Symptomatic Patients With Chronic Lymphocytic Leukemia

Summary

This is a phase II, non-randomized, single institution study in symptomatic, previously untreated CLL patients. All patients will receive the study drug, lenalidomide, given PO daily continuously on a 28 day cycle at the starting dose level of either 2.5 mgs or 5 mgs with dose escalations to a target dose of 25mg daily. Oral dexamethasone at 12 mg PO daily will be administered on days 1-7, 14 and 21 of each cycle. Patients will be treated with lenalidomide and dexamethasone to 2 cycles past CR or to a maximum of 18 cycles, each cycle of 28 days duration. Primary endpoint is response.

Timeline

Start

2010-05

Primary completion

2016-12

Completion

2016-12

Publications

• Chen CI, Paul H, Snitzler S, Kakar S, Le LW, Wei EN, Lau A, Johnston JB, Gibson SB, Queau M, Spaner D, Croucher D, Sherry B, Trudel S. A phase 2 study of lenalidomide and dexamethasone in previously untreated patients with chronic lymphocytic leukemia (CLL). Leuk Lymphoma. 2019 Apr;60(4):980-989. doi: 10.1080/10428194.2018.1508669. Epub 2018 Oct 2.

Drugs

Indications