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Not yet recruiting NCT07516093

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

Phase III Interventional B-cell Lymphoma Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NX-5948, Pirtobrutinib.
Who it may be relevant to
Registry conditions: B-cell Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Interventions

  • Drug NX-5948
    Administered orally once daily
  • Drug Pirtobrutinib
    Administered orally once daily per prescribing information

Primary outcome measures

  • Progression-free survival (PFS) as assessed by Independent Review Committee (IRC) [Time frame: Up to approximately 3.5 years]
Secondary outcome measures (11)
  • Overall survival [Time frame: Up to approximately 6 years]
  • PFS as assessed by the investigator [Time frame: Up to approximately 6 years]
  • Objective response rate (ORR) with and without partial response with lymphocytosis (PR-L) as assessed by IRC and investigator [Time frame: Up to approximately 6 years]
  • Duration of response with and without PR-L as assessed by IRC and investigator [Time frame: Up to approximately 6 years]
  • Time to next anti-CLL/SLL treatment as assessed by IRC and by investigator [Time frame: Up to approximately 6 years]
  • Change from baseline in global health status/quality of life on the European Organization for Research and Treatment of Cancer Quality of Life Cancer Questionnaire C30 with CLL module (EORTC QLQ-C30-CLL17) [Time frame: Baseline and up to approximately 6 years]
  • Change from baseline in EuroQol-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) [Time frame: Baseline and up to approximately 6 years]
  • Number of participants with treatment-emergent adverse events [Time frame: Up to approximately 6 years]
  • Pharmacokinetic profile of NX-5948 [Time frame: Up to Cycle 13 Day 1 (each cycle is 28 days)]
  • Number of participants with clinically significant changes from baseline in laboratory parameters [Time frame: Up to approximately 6 years]
  • Number of participants with clinically significant changes from baseline in vital signs [Time frame: Up to approximately 6 years]

Eligibility criteria

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 one 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07516093 · NX-5948-306 · 2025-524145-27-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗