A Study of NX-5948 in Adults With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor (BTKi) and a Bcell Lymphoma-2 Inhibitor (BCL-2i) (DAYBreak CLL-201)
Key facts
- Where
- Debrecen, MagyarországSee the site
- Phase
- 2. fázis
Where in Magyarország
- University of DebrecenDebrecen, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nurix Therapeutics Inc.
- Trial code
- EU 2025-521088-10-00
- Record updated
- 2026. augusztus 24.
- Original description
To evaluate the efficacy of NX-5948 in adults with R/R CLL/SLL previously exposed to a cBTKi, an ncBTKi and a BCL2i in accordance with the 2018 International Workshop on CLL (iwCLL) guidelines (Hallek 2018)Read full original descriptionShow less
A Single-arm, Phase 2, Open-label, Multicenter Study to Evaluate NX-5948 in Adults with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Previously Exposed to a Bruton’s Tyrosine Kinase Inhibitor (BTKi) and a B-cell Lymphoma-2 Inhibitor (BCL-2i)
To evaluate the efficacy of NX-5948 in adults with R/R CLL/SLL previously exposed to a cBTKi, an ncBTKi and a BCL2i in accordance with the 2018 International Workshop on CLL (iwCLL) guidelines (Hallek 2018)
Inclusion: Age: ≥ 18 years; Confirmed diagnosis of CLL/SLL that meets iwCLL criteria diagnosis and systemic treatment (Hallek 2018); Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2; Prior exposure to both a cBTKi, an ncBTKi and a BCL-2i either in separate lines of therapy or in combination; Patients with SLL must have measurable disease by computed tomography (CT) per iwCLL. Measurable disease is defined as at least 1 lymph node >1.5 cm in longest diameter and measurable in 2 perpendicular dimensions; Adequate organ and bone marrow function.
Exclusion: Known or suspected prolymphocytic leukemia or more aggressive phenotype, including Richter’s transformation, a positron emission tomography (PET) scan should be performed and the treating physician may determine if histopathological evaluation should be performed and results reviewed by the treating physician to rule out transformation prior to enrollment; Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) before planned start of study drug; Palliative limited-field radiotherapy within 7 days of the first dose of study drug except for broad field radiotherapy (≥30% of bone marrow or whole brain radiotherapy) within 28 days of the first dose of study drug.."; Use of systemic corticosteroids >20 mg/day prednisone or equivalent within the 7 days prior to initiation of study drug excepting those used as prophylaxis for radio diagnostic contrast; Use of systemic immunosuppressive drugs other than systemic corticosteroids for any medical condition within 60 days prior to first dose of study drug; Previously treated with a BTK degrader.