A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (RESONATE™)
|Relapsed or Refractory Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma||Drug: ofatumumab Drug: ibrutinib||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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|
- PFS (Progression Free Survival) [ Time Frame: Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled. ]
The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS).
Progressive disease according to 2008 IWCLL guidelines was defined as:
- Lymphadenopathy, increase ≥50%
- Hepatomegaly, increase ≥50%
- Splenomegaly, increase ≥50%
- Blood lymphocytes, increase ≥ 50% over baseline
- Platelets counts, decrease of ≥ 50% from baseline secondary to CLL
- Hemoglobin, decrease of > 2 g/dL from baseline secondary to CLL
- OS (Overall Survival) [ Time Frame: OS analysis was conducted at the time of the interim PFS analysis, which was about 18 months after the first subject was enrolled. ]
- Hematological Improvements [ Time Frame: 2 years ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||November 2018|
|Primary Completion Date:||November 2013 (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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578707
Show 76 Study Locations
|Study Director:||George Cole, MD||Pharmacyclics LLC.|