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

RecruitingPhase 3Ages 18 Years - anyAllNewave Pharmaceutical Inc
NCT07342478 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 endpoin

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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; * 17p deletion status confirmed by FISH; 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);
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What it tests

  • Rocbrutinib
  • Pirtobrutinib
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Where

6 sites
Orchard Healthcare Research
Skokie, United States
The Center for Cancer and Blood Disorders-Bethesda
Bethesda, United States
Optum Medical Group (Rhodes) P.C.
Las Vegas, United States
OSU Comprehensive Cancer Center
Columbus, United States
UPMC Hillman Cancer Center
Pittsburgh, United States
Medical Oncology Associates - Spokane
Spokane, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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