Phase 3
Completed N=269
Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Source: ClinicalTrials.gov NCT01724346 ↗Enrolled (actual)
269
Serious AEs
55.9%
Results posted
Sep 2024
Primary outcomePrimary: Progression Free Survival (PFS) Based on Investigator Assessment — 106.9; 15.0 months — p=< 0.0001
◆ Published Evidence
Highly cited
272citations · ~68 / year
Up to 8-year follow-up from RESONATE-2: first-line ibrutinib treatment for patients with chronic lymphocytic leukemia.
Summary
An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib versus Chlorambucil)
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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Sustained efficacy and detailed clinical follow-up of first-line ibrutinib treatment in older patients with chronic lymphocytic leukemia: extended phase 3 results from RESONATE-2.
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Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
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Final analysis of the RESONATE-2 study: up to 10 years of follow-up of first-line ibrutinib treatment for CLL/SLL.
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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 Progression Free Survival (PFS) Based on Investigator Assessment |
106.9; 15.0 | < 0.0001 sig |
| SECONDARY Progression Free Survival After Initiation of Subsequent Anticancer Therapy (PFS2) |
79.3; 58.4 | — |
| SECONDARY Overall Survival (OS) |
82.8; 68.4 | — |
| SECONDARY Time to Next Treatment (TTNT) |
NA; 25.1 | < 0.0001 sig |
| SECONDARY Overall Response Rate (ORR) |
91.2; 36.8 | < 0.0001 sig |
| SECONDARY Rate of Minimal Residual Disease (MRD) Negativity |
5.1; 0 | — |
| SECONDARY Duration of Response (DOR) |
NA; 29.7 | — |
Eligibility Criteria
Inclusion Criteria
- Randomized in the parent study, PCYC-1115-CA
- Informed consent for Study PCYC-1116-CA
- Independent review committee (IRC)-confirmed disease progression (PD) in the parent study PCYC-1115-CA or closure of the parent study
Exclusion Criteria
- Disease progression involving the central nervous system (CNS) or transformation to another histology
- Intervening chemotherapy, immunotherapy, or investigational agent specifically to treat CLL if administered before date of IRC confirmed progressive disease
- In the 4 weeks before dosing: radiation therapy, major surgery, or receipt of an investigational drug
- Requirement for treatment with a strong CYP3A inhibitor
- Uncontrolled systemic infection or requirement for IV antibiotics
- Noncompliance on the parent study(PCYC-1115-CA)
Data sourced from ClinicalTrials.gov (NCT01724346) 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.