ROCKET-CLL Global Phase 3 Study: Comparing Rocbrutinib and Pirtobrutinib for Treating Relapsed or Resistant CLL/SLL
Sponsor: Newave Pharmaceutical Inc
ClinicalTrials ID:NCT07342478
This study is testing two medications, rocbrutinib and pirtobrutinib, to see which is more effective for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has returned or not responded to previous treatments.
Patient Parameters
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Program Overview
The study aims to compare the effectiveness and safety of two drugs, rocbrutinib and pirtobrutinib, in treating adults with CLL or SLL that has come back or not responded to treatment. Participants will be randomly assigned to take either rocbrutinib or pirtobrutinib daily. The main goal is to see how long patients live without their disease getting worse. Other goals include overall survival, response rates, and quality of life.
Description
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are types of blood cancers where certain white blood cells grow uncontrollably. This study is for patients whose CLL or SLL has returned or not responded to previous treatments, specifically those who have already tried a type of medication called a covalent Bruton's tyrosine kinase inhibitor (cBTKi).
Rocbrutinib and pirtobrutinib are both medications that target specific proteins in cancer cells to stop them from growing. This study will compare these two drugs to see which one works better and is safer for patients. Participants will take one of these medications daily in 28-day cycles until their disease progresses, they experience unacceptable side effects, or they choose to stop.
The study will involve about 306 participants from around the world. Participants will be divided into two groups, with one group receiving rocbrutinib and the other receiving pirtobrutinib. The study will track how long participants live without their disease getting worse, as well as overall survival, response rates, and any side effects experienced.
Participants will be monitored through regular check-ups, blood tests, and other assessments to ensure their safety and to evaluate the effectiveness of the treatment. The study also aims to understand how these drugs affect patients' quality of life and to explore potential biological markers that could predict treatment success.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of CLL or SLL.
- Disease must have returned or not responded to previous treatments.
- Must have been treated with a covalent BTK inhibitor before.
- Have measurable disease that can be tracked.
- Be in good general health with an ECOG performance status of 0 to 2.
- Have adequate blood, liver, and kidney function.
- Have specific genetic markers confirmed by tests.
Exclusion Criteria
- Have not been treated with non-covalent BTK inhibitors or BTK degraders before.
- Have a different type of leukemia called Richter's transformation or prolymphocytic leukemia.
- Have uncontrolled health conditions or infections.
- Have cancer that has spread to the brain or spinal cord.
- Have another active cancer requiring treatment, except for certain treated cancers.
- Be pregnant or breastfeeding.
- Be taking medications or have conditions that interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| The Center for Cancer and Blood Disorders-Bethesda | 20817 | Bethesda | Maryland |
| Optum Medical Group (Rhodes) P.C. | 89102 | Las Vegas | Nevada |
| OSU Comprehensive Cancer Center | 43210 | Columbus | Ohio |
| UPMC Hillman Cancer Center | 15213 | Pittsburgh | Pennsylvania |
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