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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
269
Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily
Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily
Progression Free Survival (PFS) Based on Investigator Assessment
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.
Time frame: Median overall follow-up of 82.7 months
Progression Free Survival After Initiation of Subsequent Anticancer Therapy (PFS2)
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.
Time frame: Median overall follow-up of 82.7 months
Overall Survival (OS)
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 frame: Median overall follow-up of 82.7 months
Time to Next Treatment (TTNT)
Time from randomization to initiation of any subsequent treatment for chronic lymphocytic leukemia (CLL).
Time frame: Median overall follow-up of 82.7 months
Overall Response Rate (ORR)
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.
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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
St 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
...and 78 more locations
Time frame: Median overall follow-up of 82.7 months
Rate of Minimal Residual Disease (MRD) Negativity
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.
Time frame: Median overall follow-up of 82.7 months
Duration of Response (DOR)
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.
Time frame: Median overall follow-up of 82.7 months