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Compares treatment options for CLL / SLL
Official title ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL
ClinicalTrials.gov ID: NCT07342478
What this study is testing
What is Rocbrutinib?
Rocbrutinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cll / sll.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- Prior ncBTKi or BTK degraders;
- Richter's transformation;
- Confirmed prolymphocytic leukemia;
- Uncontrolled comorbidities or infections;
- Known CNS involvement by CLL/SLL;
- Prior malignancy requiring active treatment (except certain adequately treated cancers) per protocol;
See the full eligibility 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 function;
- TP53 mutation status confirmed by NGS;
- 17p deletion status confirmed by FISH;
- Prior ncBTKi or BTK degraders;
- Richter's transformation;
- Confirmed prolymphocytic leukemia;
- Uncontrolled comorbidities or infections;
- Known CNS involvement by CLL/SLL;
- Prior malignancy requiring active treatment (except certain adequately treated cancers) per protocol;
- Pregnancy or breastfeeding;
- Concomitant medications or conditions prohibited by protocol (e.g., strong drug-drug interaction risk);
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
- Las Vegas, Nevada, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States; Las Vegas, Nevada, United States; Columbus, Ohio, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.