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)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pharmacyclics LLC.
- Enrollment
- 232
- Locations
- 88
- Primary Endpoint
- Progression Free Survival (PFS) Based on Investigator Assessment
Study Overview
Brief 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)
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Open label study
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Randomized in the parent study, PCYC-1115-CA
- •Informed consent for Study PCYC-1116-CA
- •IRC-confirmed 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)
Arms & Interventions
Chlorambucil
Participants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after disease progression (PD).
Intervention: Ibrutinib (Drug)
Ibrutinib
Participants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
Intervention: Next-line ibrutinib (Drug)
Outcomes
Primary Outcomes
Progression Free Survival (PFS) Based on Investigator Assessment
Time Frame: Median overall follow-up of 82.7 months
PFS is defined as the time from the date of randomization to the date of disease progression determined by the investigator or date of death from any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to disease progression (PD) or death. Estimated by Kaplan-Meier method.
Secondary Outcomes
- Progression Free Survival After Initiation of Subsequent Anticancer Therapy (PFS2)(Median overall follow-up of 82.7 months)
- Overall Survival (OS)(Median overall follow-up of 82.7 months)
- Time to Next Treatment (TTNT)(Median overall follow-up of 82.7 months)
- Overall Response Rate (ORR)(Median overall follow-up of 82.7 months)
- Rate of Minimal Residual Disease (MRD) Negativity(Median overall follow-up of 82.7 months)
- Duration of Response (DOR)(Median overall follow-up of 82.7 months)