RightFit
RecruitingPhase 3

Study of NX-5948 Versus Pirtobrutinib in R/R CLL/SLL

A Phase 3, Randomized, Open-label, Multicenter Study of NX-5948 Versus Pirtobrutinib in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

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

Not stated in the study description — ask the study team about visits and procedures.

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 NX-5948 (bexobrutideg) with pirtobrutinib to see how well they work and how safe they are. It is for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose cancer came back or did not respond after treatment with a covalent BTK inhibitor, a type of cancer drug.

The study will evaluate the efficacy and safety of NX-5948 (bexobrutideg) versus pirtobrutinib in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who are relapsed or refractory to prior covalent Bruton tyrosine kinase inhibitor (cBTKi) treatment.

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

Eligibility

Who can join

  • Can do daily self-care and are up and about at least half of waking hours (ECOG score of 0 to 2).
  • Organs and bone marrow, which makes blood cells, work well enough.
  • Have confirmed CLL or SLL that meets the 2018 iwCLL guidelines for diagnosis and treatment with medicines.
  • Had at least one past CLL or SLL treatment that included a covalent BTK inhibitor, with records showing the cancer got worse during or after that treatment.
  • For people with SLL, the cancer must be measurable on a CT scan under iwCLL guidelines.

Who can't join

  • Have or may have prolymphocytic leukemia, another blood cancer, or have ever had Richter's transformation, when CLL or SLL changes into a faster-growing cancer.
  • Had an experimental drug or cancer treatment too recently: within 14 days or five drug half-lives before study treatment, whichever is shorter. A half-life is the time it takes the body to clear half of a drug.
  • Currently take steroids that act throughout the body at a dose equal to 10 mg or more of prednisone each day.
  • Previously received a BTK degrader or a noncovalent BTK inhibitor, two types of cancer drugs.
  • Had a heart attack, unstable chest pain, unstable heart disease with symptoms from poor blood flow, a heart artery stent, or another major heart problem within six months before study treatment.
  • Had a blood clot that blocked a blood vessel, a stroke, or bleeding inside the skull within six months before study treatment.

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

Official eligibility criteria

Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Adequate organ and bone marrow function * Confirmed diagnosis of CLL/SLL that meets iwCLL 2018 criteria for diagnosis and systemic treatment * Received at least 1 prior line of therapy for CLL/SLL that included a cBTKi and must have documented disease progression during treatment with, or after discontinuation of, the cBTKi * Participants with SLL must have measurable disease by computed tomography (CT) per iwCLL Key Exclusion Criteria: * Known or suspected prolymphocytic leukemia or Richter's transformation at any time preceding enrollment * Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) prior to planned start of study treatment * Ongoing systemic corticosteroids ≥10 mg/day prednisone or equivalent * Previously treated with a BTK degrader or a noncovalent BTKi * Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, placement of a coronary arterial stent, or any other significant cardiac condition within 6 months of planned start of study treatment * Thromboembolic events, stroke, or intracranial hemorrhage within 6 months of planned start of study treatment Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.

Study sites (6)

GA

IN

TN

TX

VA