drugset / Trial / NCT01732861

Safety Study of CC-292 and Lenalidomide in Subjects With Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma

NCT01732861

Phase 1 Completed 20 enrolled Celgene Corporation
NaSingle-groupOpen-labelTreatment

Summary

This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the combination of CC-292 and lenalidomide in subjects with Chronic Lymphocytic Leukemia (CLL).

Timeline

Start
2012-12-28
Primary completion
2019-01-23
Completion
2019-01-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified 10 mg
Subject Spebrutinib Small molecule 375 mg
Subject Spebrutinib Small molecule 500 mg