Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- Conditions
- Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
- Interventions
- Registration Number
- NCT01724346
- Lead Sponsor
- Pharmacyclics LLC.
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 232
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Chlorambucil Ibrutinib 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). Ibrutinib Next-line 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.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Based on Investigator Assessment 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 Outcome Measures
Name Time Method Progression Free Survival After Initiation of Subsequent Anticancer Therapy (PFS2) Median overall follow-up of 82.7 months PFS2 is defined as the time from the date of randomization to the earliest occurrence of the following three types of events:
* PD per investigator response assessment after initiation of the first subsequent anti-cancer therapy
* Initiation of second subsequent anti-cancer therapy
* Death due to any cause, regardless of administration of subsequent anticancer therapy.
Kaplan-Meier landmark estimate of the PFS2 rate at 60 months (that is, the estimated percentage of participants with PFS2 at Month 60) is presented.Overall Survival (OS) Median overall follow-up of 82.7 months OS is defined as the time from randomization to death due to any cause. Kaplan-Meier landmark estimate of the OS rate at 60 months (that is, the estimated percentage of participants with OS at Month 60) is presented.
Time to Next Treatment (TTNT) Median overall follow-up of 82.7 months Time from randomization to initiation of any subsequent treatment for chronic lymphocytic leukemia (CLL).
Overall Response Rate (ORR) Median overall follow-up of 82.7 months ORR is defined as the percentage of participants who achieve complete response (CR), complete response with an incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR), as determined by the investigator at or prior to initiation of subsequent antineoplastic therapy according to the International Workshop on CLL (iwCLL) 2008 criteria with the 2012 iwCLL modification stating that treatment-related lymphocytosis in the setting of improvement in other parameters was not considered as PD and the 2013 iwCLL clarification of criteria for a partial response to therapy.
Rate of Minimal Residual Disease (MRD) Negativity Median overall follow-up of 82.7 months Percentage of participants who achieved MRD-negative response defined as \< 1 CLL cell per 10,000 leukocytes as assessed by flow cytometry of a bone marrow aspirate and/or peripheral blood sample per central laboratory at or prior to initiation of subsequent antineoplastic therapy.
Duration of Response (DOR) Median overall follow-up of 82.7 months DOR will be calculated for the participants achieving a protocol-defined response (Halleck 2008; CR, CRi, nPR, PR) per investigator assessment and is defined as time from the date of initial response including PR with lymphocytosis to the date of disease progression or the date of death from any cause, whichever occurs first.
Trial Locations
- Locations (88)
City of Hope /ID# 1116-0047
🇺🇸Duarte, California, United States
Moores Cancer Center at UC San Diego /ID# 1116-0408
🇺🇸La Jolla, California, United States
Stanford University/Stanford Cancer Center, Campus Drive /ID# 1116-0038
🇺🇸Stanford, California, United States
University of Chicago /ID# 1116-0126
🇺🇸Chicago, Illinois, United States
Norton Cancer Institute - St Matthews /ID# 1116-0071
🇺🇸Louisville, Kentucky, United States
Comprehensive Cancer Centers of Nevada /ID# 1116-0712
🇺🇸Henderson, Louisiana, United States
University of Massachusetts - Worcester /ID# 1116-0307
🇺🇸Worcester, Massachusetts, United States
Washington University-School of Medicine /ID# 1116-0221
🇺🇸Saint Louis, Missouri, United States
Northwell Health/Long Island Jewish Hospital /ID# 1116-0350
🇺🇸New Hyde Park, New York, United States
University of Rochester Medical Center /ID# 1116-0127
🇺🇸Rochester, New York, United States
Scroll for more (78 remaining)City of Hope /ID# 1116-0047🇺🇸Duarte, California, United States