drugset / Trial / NCT01744626

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

NCT01744626

Phase 1 Completed 40 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 Rituximab in subjects with CLL.

Timeline

Start
2012-12
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody
Subject Spebrutinib Small molecule 375 mg
Subject Spebrutinib Small molecule 500 mg