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ROCKET-CLL Global Study: Rocbrutinib vs Pirtobrutinib for Relapsed/Refractory CLL/SLL

This study is comparing two medicines, rocbrutinib and pirtobrutinib, for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or not responded to previous treatments. Specifically, you must have already received a type of medicine called a covalent BTK inhibitor. Researchers want to see if rocbrutinib is better than pirtobrutinib at preventing the disease from getting worse or causing death. To join, you must be at least 18 years old, have confirmed CLL/SLL, and have certain genetic markers (TP53 mutation and 17p deletion) confirmed by specific tests. About 306 people will participate in this study.

Study design
This is a Phase 3, randomized, open-label study comparing rocbrutinib to pirtobrutinib. Approximately 306 participants will be randomly assigned to receive one of the two medicines.
What's involved
You would take either rocbrutinib or pirtobrutinib orally once daily in 28-day cycles until your disease progresses, side effects are too severe, you withdraw, or other reasons for stopping are met.
Compensation
Not stated in the trial record.
Follow-up
Your disease progression or death will be assessed for up to approximately 4 years after randomization.

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NCT07342478

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Newave Pharmaceutical Inc
~306 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:RocbrutinibPirtobrutinib

At a glance

Recruiting sites
4 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PFS assessed by IRC
Measured over From randomization until disease progression or death from any cause, assessed up to approximately 4 years.

Conditions

CLL / SLL
CLL (Chronic Lymphocytic Leukemia)
CLL, Refractory
CLL, Relapsed
SLL (Small Lymphocytic Lymphoma)
SLL
CLL
CLL Progression

Explore related trials

Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaLoss of Chromosome 1pTP53 Gene

Where it's being run

6 sites across 6 states
Illinois1
Maryland1
Nevada1
Ohio1
Pennsylvania1
Washington1

Who to contact

Anna Y Chen, M.D., Ph.D.
[email protected]
1-206-335-3820
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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;
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);

What this trial measures

  • PFS assessed by IRCFrom randomization until disease progression or death from any cause, assessed up to approximately 4 years.

    Progression-Free Survival assessed by independent review committee. PFS is defined as the time from the date of randomization to disease progression or death from any cause, whichever occurs first. Those who do not experience disease progression or death at the time of analysis are censored according to the last evaluation time point.