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RecruitingPhase 3

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

A Phase 3 Open-Label, Randomized, Multicenter Study of Rocbrutinib (LP-168) vs Pirtobrutinib in Covalent BTK Inhibitor (cBTKi) Pretreated Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) Subjects

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Heart tracing (ECG), Physical exams

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Safety will be assessed through evaluation of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest, deaths, physical examinations, vital signs, electrocardiograms, and clinical laboratory assessments."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares rocbrutinib with pirtobrutinib for adults with CLL or SLL, two types of blood cancer. It is for people whose cancer came back or did not respond to treatment after taking a covalent BTK inhibitor, a drug that blocks a protein cancer cells use to grow. The study tests how long each drug keeps the cancer from getting worse and checks side effects.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • Tests confirm that you have CLL or SLL.
  • Your cancer came back or did not respond to treatment, and it needs treatment now.
  • You have had cancer treatment that included a covalent BTK inhibitor.
  • Your cancer can be measured.
  • You can care for yourself and are out of bed or a chair for more than half of your waking hours.
  • Your bone marrow, liver, and kidneys work well enough for the study.
  • You have specific genetic tests to check for a change in the TP53 gene and a missing part of chromosome 17.

Who can't join

  • You have taken a noncovalent BTK inhibitor or a BTK degrader, other types of drugs that target the BTK protein.
  • Your CLL or SLL has changed into a faster-growing lymphoma, called Richter's transformation.
  • You have a blood cancer called prolymphocytic leukemia.
  • You have other health problems or infections that are not controlled.
  • Your CLL or SLL is known to affect your brain or spinal cord.
  • You have had another cancer that needs active treatment, unless it is one of the treated cancers allowed by the study.
  • You are pregnant or breastfeeding.
  • You take medicines or have conditions the study does not allow, such as medicines that may strongly interact with the study drug.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 function; * TP53 mutation status confirmed by NGS; * 17p deletion status confirmed by FISH; Exclusion Criteria: * 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);

Study sites (6)

IL

MD

NV

OH

PA

WA