Rocbrutinib compared with pirtobrutinib in chronic lymphocytic leukemia that returned or did not respond
Compares rocbrutinib with pirtobrutinib in adults with chronic lymphocytic leukemia after earlier treatment.
Plain-language title generated from the registry record
Registry title: ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL
Key facts
- Where
- Bergamo, Cuneo, Ferrara, Milan, Naples, Pisa, Ravenna, Rome, Rozzano, and Terni, ItalySee the 11 sites
- Phase
- Phase 3
Where in Italy
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyNot yet recruiting
- Azienda Ospedaliera Santa Croce E CarleCuneo, ItalyNot yet recruiting
- Università degli Studi di FerraraFerrara, ItalyNot yet recruiting
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyNot yet recruiting
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyNot yet recruiting
- Azienda Unità Sanitaria Locale della RomagnaRavenna, ItalyNot yet recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNot yet recruiting
- Humanitas Mirasole S.p.A.Rozzano, ItalyNot yet recruiting
- Azienda Ospedaliera S Maria Di TerniTerni, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Newave Pharmaceutical Inc
- Trial code
- NCT07342478EU 2026-525656-28-00
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 3 Open-Label, Randomized, Multicenter Study of Rocbrutinib (LP-168) vs Pirtobrutinib in Covalent BTK Inhibitor (cBTKi) Pretreated Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) Subjects
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.
Inclusion: 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: Prior ncBTKi or BTK degraders; Concomitant medications or conditions prohibited by protocol (e.g., strong drug-drug interaction risk); Uncontrolled comorbidities or infections; Prior malignancy requiring active treatment (except certain adequately treated cancers) per protocol; Richter's transformation; Confirmed prolymphocytic leukemia; Known CNS involvement by CLL/SLL; Pregnancy or breastfeeding.