Overview

This trial is active, not recruiting.

Conditions relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma
Treatments ofatumumab, ibrutinib
Phase phase 3
Target BTK
Sponsor Pharmacyclics
Collaborator Janssen Research & Development, LLC
Start date June 2012
End date June 2017
Trial size 391 participants
Trial identifier NCT01578707, 2012-000694-23, PCYC-1112-CA

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
An anti-CD20 monoclonal antibody
ofatumumab
The 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)
(Experimental)
A Bruton Tyrosine Kinase Inhibitor
ibrutinib
ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity

Primary Outcomes

Measure
PFS (Progression Free Survival)
time frame: Analysis will be conducted after observing approximately 117 PFS events

Secondary Outcomes

Measure
OS (Overall Survival)
time frame: 5 years
Hematological Improvements
time frame: 2 years
Improvement of disease-related symptoms (fatigue, night sweats, and splenomegaly).
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - ECOG performance status of 0-1. - Diagnosis of CLL or SLL that meets IWCLL 2008 criteria. - Active disease meeting at least 1 of the IWCLL 2008 criteria for requiring treatment. - Must have received at least one prior therapy for CLL/SLL. - Considered not appropriate for treatment or retreatment with purine analog based therapy. - Measurable nodal disease by CT. - Patients must be able to receive outpatient treatment and laboratory monitoring at the institution that administers study drug for the entire study. Exclusion Criteria: - Known CNS lymphoma or leukemia. - No documentation of cytogenetic and/or FISH in patient records prior to first dose of study drug. - Any history of Richter's transformation or prolymphocytic leukemia. - Uncontrolled Autoimmune Hemolytic Anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP). - Prior exposure to ofatumumab or to ibrutinib. - Prior autologous transplant within 6 months prior to first dose of study drug. - Prior allogeneic stem cell transplant within 6 months or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug. - History of prior malignancy, with the exception of certain skin cancers and malignancies treated with curative intent and with no evidence of active disease for more than 3 years. - Serologic status reflecting active hepatitis B or C infection. - Unable to swallow capsules or disease significantly affecting gastrointestinal function. - Uncontrolled active systemic fungal, bacterial, viral, or other infection. - History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug. - Requires anticoagulation with warfarin.

Additional Information

Official title 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
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 who experience disease progression (PD) may be considered to receive next subsequent therapy with ibrutinib.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Pharmacyclics.