Rocbrutinib versus pirtobrutinib for adults with relapsed or refractory CLL/SLL after a covalent BTK inhibitor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label, global Phase 3 trial enrolling about 306 adults with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor. Participants are randomized 1:1 to receive oral rocbrutinib 200 mg once daily or oral pirtobrutinib 200 mg once daily in continuous 28-day cycles until progression, unacceptable toxicity, or other discontinuation criteria. Randomization is stratified by del(17p)/TP53 mutation status, reason for stopping prior cBTKi (toxicity vs progression), prior BCL2 inhibitor exposure, and geographic region. The primary endpoint is progression-free survival assessed by an independent review committee using iwCLL criteria, with additional safety and secondary efficacy measures collected.

Why it matters

Who can join: the full rules

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);

Where it's running

• Orchard Healthcare Research
  Skokie, Illinois, United States Recruiting
• The Center for Cancer and Blood Disorders-Bethesda
  Bethesda, Maryland, United States Recruiting
• Optum Medical Group (Rhodes) P.C.
  Las Vegas, Nevada, United States Recruiting
• Duke Adult Blood and Marrow Clinic
  Durham, North Carolina, United States Recruiting
• UPMC Hillman Cancer Center
  Pittsburgh, Pennsylvania, United States Recruiting
• Medical Oncology Associates - Spokane
  Spokane, Washington, United States Recruiting

Study contacts

• Study coordinator: Anna Y Chen, M.D., Ph.D.
• Email: ROCKET-CLL@newavepharma.com
• Phone: 1-206-335-3820

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.