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.
Janssen Research & Development, LLC
Information provided by (Responsible Party):
First received: April 11, 2012
Last updated: April 18, 2013
Last verified: February 2013
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)
Relapsed or Refractory Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2015 (Final data collection date for primary outcome measure)
Active Comparator: Ofatumumab (Arm A)
An anti-CD20 monoclonal antibody
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
ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578707
|The Ohio State University
|Columbus, Ohio, United States, 43210 |
Janssen Research & Development, LLC
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 11, 2012
||April 18, 2013
||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:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Immune System Diseases