A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (RESONATE™)
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|ClinicalTrials.gov Identifier: NCT01578707|
Recruitment Status : Active, not recruiting
First Posted : April 17, 2012
Results First Posted : October 12, 2015
Last Update Posted : May 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Relapsed or Refractory Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma||Drug: ofatumumab Drug: ibrutinib||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||391 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 2012|
|Actual Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||November 2018|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578707
Show 76 Study Locations
|Study Director:||Jim Dean, MD, PhD||Pharmacyclics LLC.|