The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
737
Administered orally.
Administered orally.
Pacific Cancer Medical Center, Inc
Anaheim, California, United States
RECRUITINGTOI Clinical Research
Cerritos, California, United States
RECRUITINGStanford School of Medicine-Cancer Clinical Trials Office
Palo Alto, California, United States
RECRUITINGCalifornia Cancer Associates for Research and Excellence
San Marcos, California, United States
Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (Cri), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 1
ORR as assessed by independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria
Time frame: Baseline to best overall response the best response recorded from Cycle 1 Day 1 until data cutoff date, PD, or start of new anticancer treatment, whichever is the earliest] (approximately 3 years and 5 months)
Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 2
ORR as assessed by independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria
Time frame: Baseline to best overall response the best response recorded from Cycle 1 Day 1 until data cutoff date, PD, or start of new anticancer treatment, whichever is the earliest (Approximately 2 years and 3 months)
IRC-assessed Progression-Free Survival (PFS)
PFS by IRC per iwCLL 2018 criteria
Time frame: Randomization to PD (per iwCLL 2018 criteria) or death from any cause (approximately 5 years 8 months)
Investigator assessed Progression-Free Survival (PFS)
PFS by Investigator per iwCLL 2018 criteria
Time frame: Randomization to PD (per iwCLL 2018 criteria) or death from any cause (approximately 5 years 8 months)
Event-Free Survival (EFS)
EFS by IRC per iwCLL 2018 criteria
Time frame: Randomization to first occurrence of treatment discontinuation due to adverse event/toxicity, treatment-emergent atrial fibrillation or atrial flutter of any grade, progressive disease (PD) or death (approximately 4 years)
Duration of Response (DOR)
DOR by IRC and Investigator by iwCLL 2018 Criteria.
Time frame: Time from the date of the first documented response of CR, CRi, nPR or PR to the earlier of documentation of definitive PD (per iwCLL 2018 criteria) or death from any cause (approximately 2 years)
Overall Survival (OS)
OS
Time frame: Randomization to death from any cause (approximately 6 years)
Time to Next Treatment (TTNT)
TTNT
Time frame: Randomization to initiation of the next systemic anticancer therapy for CLL/SLL or death from any cause, whichever occurs first (approximately 6 years)
Time to Worsening (TTW) of CLL/SLL Related Symptoms
Using symptom questions identified from the EORTC item library. The range of raw scores for these items could be from 0 to 52 with highest score being worse symptoms.
Time frame: Randomization to time to worsening symptoms (approximately 4 years)
Comparative Tolerability
Comparative Tolerability measured by proportion of time with high side-effect burden
Time frame: From Baseline to Treatment Discontinuation for Any Reason (approximately 4 years)
Percentage of Participants Achieving DOR Part 2
DOR as assessed by IRC and Investigator defined as the time from the date of the first documented response of CR, CRi, nPR, or PR to the earlier of the documentation of definitive PD per iwCLL 2018 criteria or death from any cause.
Time frame: Time from the date of the first documented response of CR, CRi, nPR, or PR to the earlier of the documentation of definitive PD or death from any cause] (Approximately 2 years)
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
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CONTACT
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Florida Cancer Specialists
Fort Myers, Florida, United States
RECRUITINGCancer Specialists of North Florida -St Augustine
Saint Augustine, Florida, United States
RECRUITINGFlorida Cancer Specialists East
West Palm Beach, Florida, United States
RECRUITINGHematology Oncology Clinic
Baton Rouge, Louisiana, United States
ACTIVE_NOT_RECRUITINGTulane Cancer Center Office of Clinical Research
New Orleans, Louisiana, United States
ACTIVE_NOT_RECRUITINGAmerican Oncology Partners of Maryland, PA
Bethesda, Maryland, United States
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