NCT07342478 is a Phase 3 clinical trial of Rocbrutinib in CLL / SLL, sponsored by Newave Pharmaceutical Inc.

Who is sponsoring NCT07342478?

NCT07342478 is sponsored by Newave Pharmaceutical Inc.

What drugs are being tested in NCT07342478?

Interventions in NCT07342478: Rocbrutinib, Pirtobrutinib.

What condition does NCT07342478 study?

NCT07342478 studies CLL / SLL, CLL (Chronic Lymphocytic Leukemia), CLL, Refractory, CLL, Relapsed, SLL (Small Lymphocytic Lymphoma), SLL, CLL, CLL Progression.

Is NCT07342478 still recruiting?

NCT07342478 is currently not yet recruiting. Last updated 16 January 2026.

Last reviewed 2026-01-16 · How we verify

NCT07342478

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Not yet recruiting Phase 3 Last updated 16 January 2026

What this trial tests

Phase 3 trial testing Rocbrutinib in CLL / SLL in 306 participants. Not yet recruiting.

Timeline

30 January 2026

Primary endpoint
30 October 2029

30 July 2030

Quick facts

Lead sponsor	Newave Pharmaceutical Inc
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	306
Start date	30 January 2026
Primary completion	30 October 2029
Estimated completion	30 July 2030

Drugs / interventions tested

Rocbrutinib — full drug profile →
Pirtobrutinib — full drug profile →

Conditions studied

CLL / SLL — all drugs for CLL / SLL →
CLL (Chronic Lymphocytic Leukemia) — all drugs for CLL (Chronic Lymphocytic Leukemia) →
CLL, Refractory — all drugs for CLL, Refractory →
CLL, Relapsed — all drugs for CLL, Relapsed →

Sponsor

Newave Pharmaceutical Inc — full company profile →

Who can join

18 and older, any sex, with CLL / SLL or CLL (Chronic Lymphocytic Leukemia). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Rocbrutinib

Trials testing the same drug.

NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
NCT07189065 — A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma · Phase 2 · recruiting
NCT06251180 — Phase Ib Study of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-cell Non-Hodgkin Lymphoma · Phase 1 · recruiting
NCT05716087 — A Study of Rocbrutinib in Participants With Relapse or Refractory Mantle Cell Lymphoma · Phase 2 · active not recruiting

Other Newave Pharmaceutical Inc trials

Trials by the same sponsor.

NCT04771572 — Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory CLL, SLL, MDS, MDS/MPN, AML, CMML-2, MPN- · Phase 1 · recruiting
NCT04775745 — Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies. · Phase 1 · recruiting
NCT04139434 — Dose-Escalation Study of Oral Administration of LP-108 as Monotherapy and in Combination With Azacitidine in Patients Wi · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07342478 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Newave Pharmaceutical Inc
Last refreshed: 16 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07342478.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing