ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Osoby w wieku 18 lat lub starsze
- •Zdiagnozowana przewlekła białaczka limfocytowa (CLL) lub chłoniak limfocytowy (SLL) wymagająca leczenia
- •Choroba nawróciła lub nie zareagowała na wcześniejsze leczenie
- •Przed leczeniem zastosowano lek z grupy inhibitorów kinazy BTK (cBTKi)
- •Rak jest możliwy do zmierzenia
- •Ogólny stan zdrowia pozwala na leczenie (ocena ECOG 0-2)
- •Prawidłowe wyniki badań szpiku, wątroby i nerek
- •Potwierdzone zmiany genetyczne (mutacja TP53 lub delecja 17p)
✗ Disqualifies
- •Wcześniejsze leczenie innymi typami leków na białaczkę (np. ncBTKi, degraderami BTK)
- •Transformacja Richtera (zaawansowana postać białaczki)
- •Potwierdzona białaczka prolimfocytowa
- •Niewyrównane choroby współistniejące lub infekcje
- •Chłoniak/białaczka zajmująca ośrodkowy układ nerwowy
- •Niedawno leczony inny nowotwór złośliwy
- •Ciąża lub karmienie piersią
- •Przyjmowanie innych leków lub stany, które mogą wchodzić w interakcje z lekami badanymi
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 11, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (6)
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
Trial contact
Anna Y Chen, M.D., Ph.D.
Stephen Anthony, D.O.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/1/2026.
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