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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 is a Phase 3 study that is actively recruiting participants, run by Newave Pharmaceutical. The registered enrollment target is 306 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07342478
The ClinicalTrials.gov registry entry for NCT07342478 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 306 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Newave Pharmaceutical, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pirtobrutinib is the first listed.
NCT07342478 reports 0 study locations.
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.
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