ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL (NCT07342478)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (9 items).
Location: Orchard Healthcare Research — Skokie, Illinois
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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);
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (6 Sites)
- Orchard Healthcare Research — Skokie, Illinois
- The Center for Cancer and Blood Disorders-Bethesda — Bethesda, Maryland
- Optum Medical Group (Rhodes) P.C. — Las Vegas, Nevada
- OSU Comprehensive Cancer Center — Columbus, Ohio
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
- Medical Oncology Associates - Spokane — Spokane, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.