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NCT07342478 · ClinicalTrials.gov registry record · Phase 3
ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL
A Phase 3 study, sponsored by Newave Pharmaceutical.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 306
- Enrollment target
NCT07342478: Recruiting Phase 3 study, sponsored by Newave Pharmaceutical.
NCT07342478 is a Phase 3 study that is actively recruiting participants, run by Newave Pharmaceutical. The registered enrollment target is 306 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07342478, a Phase 3 study, is actively recruiting participants, sponsored by Newave Pharmaceutical.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 306 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG Pirtobrutinib
- DRUG Rocbrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 306 participants |
| Start Date | 2026-04-23 |
| Est. Completion | 2030-07-30 |
| Phase | Phase 3 |
What NCT07342478 shows while recruiting
NCT07342478 is an interventional study that assigns participants to a tested intervention. The registered 306 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Pirtobrutinib is the first listed.
NCT07342478 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07342478 about?
NCT07342478 is a clinical study titled "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 i...
What is the current status of trial NCT07342478?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 306 participants. The study started on 2026-04-23. Estimated completion is 2030-07-30.
What interventions are being tested in trial NCT07342478?
The interventions under investigation include: Pirtobrutinib (DRUG), Rocbrutinib (DRUG).
Who is sponsoring clinical trial NCT07342478?
This trial is sponsored by Newave Pharmaceutical, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07342478's enrollment target sits among peer trials
306 1115th of 2000 higher than 884 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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