ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL
Recruiting
Phase 3
Interventional Study
CLL / SLL
CLL (Chronic Lymphocytic Leukemia)
CLL, Refractory
CLL, Relapsed
SLL (Small Lymphocytic Lymphoma)
SLL
CLL
CLL Progression
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 306 (estimated)
- Sponsor
- Newave Pharmaceutical Inc · Industry
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About This Trial
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 m…
Trial Locations
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Eligibility Criteria
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 func…
Contacts