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

Pharmacyclics

Status and phase: Completed; Phase 3

Conditions: Small Lymphocytic Lymphoma; Relapsed or Refractory Chronic Lymphocytic Leukemia

Treatments: Drug: ibrutinib; Drug: ofatumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01578707

2012-000694-23 (EudraCT Number)

PCYC-1112-CA

Details and patient eligibility

About

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)

Full 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.

Enrollment: 391 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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391 participants in 2 patient groups

Ofatumumab (Arm A)

Active Comparator group

Description:

An anti-CD20 monoclonal antibody

Treatment:

Drug: ofatumumab

ibrutinib (Arm B)

Experimental group

Description:

A Bruton Tyrosine Kinase Inhibitor

Treatment:

Drug: ibrutinib