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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524145-27-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: NX-5948 | Experimental |
| |
| Arm B: Pirtobrutinib | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NX-5948 | Drug | Administered orally once daily |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) as assessed by Independent Review Committee (IRC) | Time from randomization to disease progression or death due to any cause, whichever is earlier | Up to approximately 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time from randomization to death from any cause | Up to approximately 6 years |
| PFS as assessed by the investigator | Time from randomization to disease progression or death due to any cause, whichever is earlier |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Additional Site Contact Information | Contact | 415-417-3418 | clinicaltrials@nurixtx.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Nurix Therapeutics, Inc. | Study Director |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000723100 | pirtobrutinib |
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| Pirtobrutinib | Drug | Administered orally once daily per prescribing information |
|
|
| Up to approximately 6 years |
| 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 | Up to approximately 6 years |
| 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 | Up to approximately 6 years |
| Time to next anti-CLL/SLL treatment as assessed by IRC and by investigator | Time from randomization to the date of next anti-CLL/SLL treatment | 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) | Percentage of participants with a clinically meaningful change from baseline using the EORTC QLQ-C30-CLL17 questionnaire to assess global health and overall quality of life | Baseline and up to approximately 6 years |
| Change from baseline in EuroQol-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) | Percentage of participants with a clinically meaningful change from baseline using the EQ-5D-5L questionnaire to assess health outcomes | Baseline and up to approximately 6 years |
| Number of participants with treatment-emergent adverse events | Up to approximately 6 years |
| Pharmacokinetic profile of NX-5948 | NX-5948 concentrations in blood samples | Up to Cycle 13 Day 1 (each cycle is 28 days) |
| Number of participants with clinically significant changes from baseline in laboratory parameters | Laboratory parameters may include hematology, clinical chemistry, and urinalysis | Up to approximately 6 years |
| Number of participants with clinically significant changes from baseline in vital signs | Vital signs include blood pressure, heart and respiratory rates, pulse oximetry, and temperature | Up to approximately 6 years |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |