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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01766583 on ClinicalTrials.gov