Phase 3
Completed N=269
Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL
Source: ClinicalTrials.gov NCT01722487 ↗Enrolled (actual)
269
Serious AEs
33.0%
Results posted
May 2016
Primary outcomePrimary: PFS (Progression Free Survival) — NA; 18.9 Months — p=<0.0001
◆ Published Evidence
Highly cited
269citations · ~67 / year
Up to 8-year follow-up from RESONATE-2: first-line ibrutinib treatment for patients with chronic lymphocytic leukemia.
Summary
A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
Linked Publications (5)
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Up to 8-year follow-up from RESONATE-2: first-line ibrutinib treatment for patients with chronic lymphocytic leukemia.
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Long-term efficacy of first-line ibrutinib treatment for chronic lymphocytic leukaemia in patients with TP53 aberrations: a pooled analysis from four clinical trials.
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Up to 6.5 years (median 4 years) of follow-up of first-line ibrutinib in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma and high-risk genomic features: integrated analysis of two phase 3 studies.
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Statin use and survival in CLL/SLL treated with ibrutinib: pooled analysis of 4 randomized controlled trials.
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Many People With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Benefit From Ibrutinib Treatment Up To 8 Years: A Plain Language Summary.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PFS (Progression Free Survival) |
NA; 18.9 | <0.0001 sig |
| SECONDARY Overall Survival (OS) |
NA; NA | 0.0010 sig |
| SECONDARY ORR (Overall Response Rate) |
82.4; 35.3 | <0.0001 sig |
| SECONDARY Proportion of Sustained Hemoglobin Improvement |
45.6; 20.3 | <0.0001 sig |
| SECONDARY Proportion of Sustained Hemoglobin Improvement in Subjects With Baseline Anemia |
84.3; 45.5 | <0.0001 sig |
| SECONDARY Proportion of Sustained Platelet Improvement |
27.2; 11.3 | .0009 sig |
| SECONDARY Proportion of Sustained Platelet Improvement in Subjects With Baseline Thrombocytopenia |
77.1; 42.9 | .0054 sig |
Eligibility Criteria
Inclusion Criteria
- Males or females of 65 years of age or greater. Patients between the ages of 65 and 70 years of age must have 1 or more of the following comorbidities that may preclude the use of frontline chemo-immunotherapy with fludarabine, cyclophosphamide, or rituximab:
- creatinine clearance 4 months from randomization
- Adequate hematologic function, defined as absolute neutrophil count (ANC) ≥ 1,000/μL (independent of growth factor support for at least 7 days prior to screening) and platelet count ≥ 50,000/μL (independent of transfusion and growth factor support for at least 7 days prior to screening)
- Adequate hepatic function, defined as serum aspartate transaminase (AST) and alanine transaminase (ALT) 20 mg prednisone (or corticosteroid equivalent, see Appendix N), or those who are administered steroids for leukemia control or white blood cell (WBC)-count-lowering are excluded.
- Major surgery within 4 weeks prior to randomization
- History of prior malignancy, with the exception of the following:
- malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening and felt to be at low risk for recurrence by treating physician
- adequately treated nonmelanomatous skin cancer or lentigo maligna melanoma without current evidence of disease
- adequately treated cervical carcinoma in situ without current evidence of disease
- Currently active, clinically significant cardiovascular disease or a history of myocardial infarction within 6 months prior to randomization
- Inability to swallow capsules or tablets, or disease significantly affecting gastrointestinal function
- Uncontrolled active systemic fungal, bacterial, viral, or other infection or requirement for intravenous (IV) antibiotics
- Known history of infection with human immunodeficiency virus (HIV)
- Serologic status reflecting active hepatitis B or C infection
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment
- Current life-threatening illness, medical condition, or organ-system dysfunction that could compromise patient safety or put the study at risk
- Requirement for anticoagulation with warfarin
- Requirement for treatment with a strong CYP3A4/5 and/or CYP2D6 inhibitor
Data sourced from ClinicalTrials.gov (NCT01722487) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.