A Phase IB Study Of The BTKi CC-292 Combined With Lenalidomide In Adults Patients With Relapsed/Refractory B-Cell Lymphoma
NCT01766583 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2018-03-07
Summary
This is an open label, 3 + 3 dose escalation study, to determine the MTD, safety, efficacy and PK profiles for subjects with relapsed/refractory B-cell malignancies when using CC-292 and lenalidomide combination therapy. Subjects will be followed for disease progression and collection of second primary malignancy (SPM) events. This dose escalation will be followed by an exploratory expansion phase in 3 cohorts of 12 patients each.
Conditions
- Relapsed/Refractory B-cell Lymphoma
Interventions
- DRUG
-
CC-292 + lenalidomide
CC-292 + lenalidomide
Sponsors & Collaborators
-
Celgene Corporation
collaborator INDUSTRY -
The Lymphoma Academic Research Organisation
lead OTHER
Principal Investigators
-
Gilles Salles, PhD · CHU Lyon - Sud - LYSA
-
Loïc YSEBAERT, MD · CHU de Toulouse LYSA
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-02-28
- Primary Completion
- 2014-11-30
- Completion
- 2018-01-31
Countries
- France
Study Locations
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