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

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 discontinuat

Trial Details

NCT ID
NCT07342478
Phase
PHASE3
Sponsor
Newave Pharmaceutical Inc
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Rocbrutinib
  • Pirtobrutinib
Locations (sample)
  • Skokie, Illinois, United States|42.03336,-87.73339
  • Bethesda, Maryland, United States|38.98067,-77.10026
  • Las Vegas, Nevada, United States|36.17497,-115.13722
  • Columbus, Ohio, United States|39.96118,-82.99879
  • Pittsburgh, Pennsylvania, United States|40.44062,-79.99589

Key Eligibility 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;

For full eligibility, visit ClinicalTrials.gov.

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