A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (RESONATE™)
This study is ongoing, but not recruiting participants.
Sponsor:
Pharmacyclics
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT01578707
First received: April 11, 2012
Last updated: April 18, 2013
Last verified: February 2013
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Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsed or Refractory Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma |
Drug: ofatumumab Drug: ibrutinib |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pharmacyclics:
Primary Outcome Measures:
- PFS (Progression Free Survival) [ Time Frame: Analysis will be conducted after observing approximately 234 PFS events ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- OS (Overall Survival) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Hematological Improvements [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Improvement of disease-related symptoms (fatigue, night sweats, and splenomegaly). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 350 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Ofatumumab (Arm A)
An anti-CD20 monoclonal antibody
|
Drug: 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: ibrutinib (Arm B)
A Bruton Tyrosine Kinase Inhibitor
|
Drug: ibrutinib
ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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/allogeneic transplant
- 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Pharmacyclics |
| ClinicalTrials.gov Identifier: | NCT01578707 History of Changes |
| Other Study ID Numbers: | PCYC-1112-CA, 2012-000694-23 |
| Study First Received: | April 11, 2012 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Agency for Health and Food Safety France: Federal Institute for Drugs and Medical Devices Ireland: Irish Medicines Board Italy: The Italian Medicines Agency Poland: The Central Register of Clinical Trials Spain: Agencia Española de Medicamentos y Productos Sanitarios United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Pharmacyclics:
|
Chronic SLL CLL Ofatumumab ibrutinib |
RESONATE Phase III Leukemia Lymphoma |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Neoplasms by Histologic Type Neoplasms |
Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013