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

ConditionsB-cell LymphomaChronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNurix Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • NX-5948

    Drug

    Administered orally once daily

  • Pirtobrutinib

    Drug

    Administered orally once daily per prescribing information

Treatment groups

620 Participants
are divided into 2 treatment groups
Group A: Arm A: NX-5948Experimental treatment 1 intervention
Group B: Arm B: PirtobrutinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS) as assessed by Independent Review Committee (IRC)

Time from randomization to disease progression per 2018 International Workshop on CLL (iwCLL) or death due to any cause, whichever is earlier

Time frame
Up to approximately 3.5 years
2

Objective response rate (ORR) without partial response with lymphocytosis (PR-L) as assessed by IRC

Percentage of participants with best overall response of complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR), or nodular PR, as assessed per 2018 iwCLL guidelines

Time frame
Up to approximately 2.5 years

Secondary outcomes

1

Overall survival

Time from randomization to death from any cause

Time frame
Up to approximately 7 years
2

PFS as assessed by the investigator

Time from randomization to disease progression or death due to any cause, whichever is earlier

Time frame
Up to approximately 3.5 years
3

Objective response rate (ORR) with and without partial response with lymphocytosis (PR-L) as assessed by IRC and investigator

Percentage of participants with best overall response of complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR) or nodular PR, or PR-L (for ORR with PR-L), as assessed per 2018 International Workshop on CLL (iwCLL) guidelines

Time frame
Up to approximately 3.5 years
4

Duration of response with and without PR-L as assessed by IRC and investigator

Time from the date of the first response to documented disease progression or death due to any cause, whichever is earlier

Time frame
Up to approximately 3.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nurix Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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