ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL

Part of paid clinical trials in Skokie, Illinois.

Sponsor
Newave Pharmaceutical Inc
Study ID
NCT07342478
Phase
PHASE3
Status
Recruiting
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Conditions

  • CLL
  • CLL (Chronic Lymphocytic Leukemia)
  • CLL / SLL
  • CLL Progression
  • CLL, Refractory
  • CLL, Relapsed
  • SLL
  • SLL (Small Lymphocytic Lymphoma)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rocbrutinib — DRUG
    The new generation, highly potent, ultra-selective BTK inhibitor with covalent and non-covalent dual binding mechanism, targeting both WT BTK and mutant BTK
  • Pirtobrutinib — DRUG
    Pirtobrutinib is a non-covalent BTK inhibitor.

Study Details

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.

Key Dates

First listed
Jan 15, 2026
Start date
Apr 23, 2026
Status verified
Aug 2026
Primary completion
Oct 30, 2029
Completion
Jul 30, 2030

Study Design

Enrollment
306 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rocbrutinib
    200mg daily
  • Active Comparator: Pirtobrutinib
    200mg daily

Primary Outcome Measure

PFS assessed by IRC [ Time Frame: From randomization until disease progression or death from any cause, assessed up to approximately 4 years. ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Orchard Healthcare ResearchSkokieIllinois60077-
The Center for Cancer and Blood Disorders-BethesdaBethesdaMaryland20817-
Optum Medical Group (Rhodes) P.C.Las VegasNevada89102-
OSU Comprehensive Cancer CenterColumbusOhio43210-
UPMC Hillman Cancer CenterPittsburghPennsylvania15213-
Medical Oncology Associates - SpokaneSpokaneWashington99208-

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Orchard Healthcare Research· Skokie, ILThe Center for Cancer and Blood Disorders-Bethesda· Bethesda, MDOptum Medical Group (Rhodes) P.C.· Las Vegas, NVOSU Comprehensive Cancer Center· Columbus, OHUPMC Hillman Cancer Center· Pittsburgh, PAMedical Oncology Associates - Spokane· Spokane, WA

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