ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL
A Phase 3 Open-Label, Randomized, Multicenter Study of Rocbrutinib (LP-168) vs Pirtobrutinib in Covalent BTK Inhibitor (cBTKi) Pretreated Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) Subjects
2 other identifiers
interventional
306
1 country
3
Brief Summary
This is a Phase 3, randomized, open-label, multicenter study comparing rocbrutinib (LP-168) versus pirtobrutinib in adult participants with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received a covalent Bruton's tyrosine kinase inhibitor (cBTKi). Approximately 306 participants will be randomized 1:1 to receive rocbrutinib 200 mg orally once daily or pirtobrutinib 200 mg orally once daily, administered continuously in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria are met. Randomization will be stratified by presence of del(17p)/TP53 mutation (yes/no), reason for discontinuation of prior cBTKi therapy (toxicity vs disease progression), prior exposure to a BCL2 inhibitor (yes/no), and region (United States/China/rest of world). The primary endpoint is progression-free survival (PFS) assessed by an independent review committee (IRC) using iwCLL 2018 criteria for CLL and Lugano 2014 criteria for SLL. Key secondary objectives include overall survival, overall response rate, time-to-event outcomes, and safety/tolerability; exploratory objectives include health-related quality of life and biomarker assessments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2026
Typical duration for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2026
CompletedFirst Posted
Study publicly available on registry
January 15, 2026
CompletedStudy Start
First participant enrolled
April 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2030
April 30, 2026
April 1, 2026
3.5 years
January 13, 2026
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PFS assessed by IRC
Progression-Free Survival assessed by independent review committee. PFS is defined as the time from the date of randomization to disease progression or death from any cause, whichever occurs first. Those who do not experience disease progression or death at the time of analysis are censored according to the last evaluation time point.
From randomization until disease progression or death from any cause, assessed up to approximately 4 years.
Secondary Outcomes (7)
OS
From randomization until death from any cause, assessed up to approximately 4 years
PFS assessed by INV
From randomization until disease progression or death from any cause, assessed up to approximately 4 years.
ORR
From randomization until disease progression, assessed up to approximately 4 years
DOR
From first documented response until disease progression or death, assessed up to approximately 4 years
TTNT
From randomization to start of next anti-CLL/SLL treatment, assessed up to approximately 4 years.
- +2 more secondary outcomes
Other Outcomes (1)
Health related quality of Life
From baseline through end of treatment and follow-up, assessed up to approximately 4 years.
Study Arms (2)
Rocbrutinib
EXPERIMENTAL200mg daily
Pirtobrutinib
ACTIVE COMPARATOR200mg daily
Interventions
The new generation, highly potent, ultra-selective BTK inhibitor with covalent and non-covalent dual binding mechanism, targeting both WT BTK and mutant BTK
Eligibility Criteria
You may qualify if:
- Age ≥18 years;
- Histologically confirmed CLL/SLL iwCLL 2018;
- Relapsed or refractory disease requiring treatment;
- Previously treated with prior lines of therapy including a covalent BTK inhibitor;
- Measurable disease;
- ECOG 0-2;
- Adequate marrow, hepatic, and renal function;
- TP53 mutation status confirmed by NGS;
- p deletion status confirmed by FISH;
You may not qualify if:
- Prior ncBTKi or BTK degraders;
- Richter's transformation;
- Confirmed prolymphocytic leukemia;
- Uncontrolled comorbidities or infections;
- Known CNS involvement by CLL/SLL;
- Prior malignancy requiring active treatment (except certain adequately treated cancers) per protocol;
- Pregnancy or breastfeeding;
- Concomitant medications or conditions prohibited by protocol (e.g., strong drug-drug interaction risk);
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Optum Medical Group (Rhodes) P.C.
Las Vegas, Nevada, 89102, United States
OSU Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2026
First Posted
January 15, 2026
Study Start
April 23, 2026
Primary Completion (Estimated)
October 30, 2029
Study Completion (Estimated)
July 30, 2030
Last Updated
April 30, 2026
Record last verified: 2026-04