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Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL

NCT01217749 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2015-06-25

Study results available
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Summary

The purpose of this study is to determine the efficacy and safety of a fixed-dose, daily regimen of orally administered PCI-32765 combined with ofatumumab in subjects with relapsed/refractory CLL/SLL and related diseases

Conditions

Interventions

DRUG

PCI-32765

420 mg PO daily

DRUG

ofatumumab

per package insert as an IV infusion

Sponsors & Collaborators

  • Ohio State University

    collaborator OTHER

  • Pharmacyclics LLC.

    lead INDUSTRY

Principal Investigators

  • Samantha Jaglowski, MD · Ohio State University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-06-30
Completion
2014-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01217749 on ClinicalTrials.gov