Clinical Trials Directory

Trials / Completed

CompletedNCT01578707

A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
391 (actual)
Sponsor
Pharmacyclics LLC. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Detailed description

Study PCYC-1112-CA is a randomized, multicenter, open-label, phase 3 study of the Bruton's Tyrosine Kinase (BTK) inhibitor Ibrutinib (PCI-32765) versus Ofatumumab in patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Patients randomized to the ofatumumab arm may be considered to receive next subsequent therapy with ibrutinib.

Conditions

Interventions

TypeNameDescription
DRUGofatumumabThe ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)
DRUGibrutinibibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity

Timeline

Start date
2012-06-01
Primary completion
2013-11-01
Completion
2018-10-25
First posted
2012-04-17
Last updated
2019-12-18
Results posted
2015-10-12

Locations

76 sites across 10 countries: United States, Australia, Austria, Belgium, France, Ireland, Italy, Poland, Spain, United Kingdom

Source: ClinicalTrials.gov record NCT01578707. Inclusion in this directory is not an endorsement.