Actively Recruiting
ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL
Led by Newave Pharmaceutical Inc · Updated on 2026-05-14
306
Participants Needed
4
Research Sites
222 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) according to iwCLL 2018 criteria
- Relapsed or refractory disease requiring treatment
- Previously treated with a covalent Bruton's tyrosine kinase inhibitor (cBTKi)
- Measurable disease
- ECOG performance status of 0 to 2
- Adequate bone marrow, liver, and kidney function
- TP53 mutation status confirmed by next-generation sequencing (NGS)
- 17p deletion status confirmed by fluorescence in situ hybridization (FISH)
You will not qualify if you...
- Prior treatment with non-covalent BTK inhibitors or BTK degraders
- Richter's transformation
- Confirmed prolymphocytic leukemia
- Uncontrolled comorbidities or infections
- Known central nervous system involvement by CLL or SLL
- Prior malignancy requiring active treatment, except certain treated cancers
- Pregnancy or breastfeeding
- Use of medications or presence of conditions that pose strong drug interaction risks as specified in the protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
The Center for Cancer and Blood Disorders-Bethesda
Bethesda, Maryland, United States, 20817
Actively Recruiting
2
Optum Medical Group (Rhodes) P.C.
Las Vegas, Nevada, United States, 89102
Actively Recruiting
3
OSU Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Not Yet Recruiting
4
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
Research Team
A
Anna Y Chen, M.D., Ph.D.
CONTACT
S
Stephen Anthony, D.O.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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