Taking people in ItalyPhase 2
Tests NX-5948 in adults with relapsed chronic lymphocytic leukemia or lymphoma
Tests NX-5948 in adults with CLL or SLL that returned after earlier treatments.
Key facts
- Who runs it
- Nurix Therapeutics Inc.
- Where
- Alessandria, Bergamo, Bologna, Brescia, Meldola, Milan, Milano, Ravenna, Rome, and Turin, ItalySee the 10 sitesAlso in 3 other countries, 6 sites
- Trial code
- Registry title
- 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)
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 45 people, planned
- Started
- 23 Oct 2025
- Expected to end
- 31 Oct 2030
- Type of study
- Interventional
- Record updated
- 24 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) came back or did not respond, after earlier treatment with a BTK inhibitor and a BCL-2 inhibitor.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Relapsed or refractory CLL or SLL that meets the 2018 iwCLL criteria. People with SLL must have measurable disease on a CT scan, at least 1 lymph node larger than 1.5 cm (0.6 in) in its longest diameter. ECOG performance status of 0 to 2.
- Earlier treatment
- Must have had a cBTKi, an ncBTKi and a BCL-2i, either in separate lines of treatment or together. Cannot have been treated with a BTK degrader before.
Main reasons for not taking part
- Known or suspected prolymphocytic leukemia or a more aggressive form, including Richter's transformation
- Investigational drug or anticancer treatment within 5 half-lives or 14 days (whichever is shorter) before the study drug starts
- Systemic corticosteroids above 20 mg/day prednisone or equivalent in the 7 days before the study drug
- Systemic immunosuppressive drugs other than corticosteroids within 60 days before the first dose
- Earlier treatment with a BTK degrader
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Italy
Also in 3 other countries, 6 sites
- Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare ArrigoAlessandria, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'OrsolaBologna, ItalyTaking people
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- San Raffaele OspedaleMilano, ItalyTaking people
- Ospedale Santa Maria delle CrociRavenna, ItalyTaking people
- Università Cattolica del Sacro CuoreRome, ItalyTaking people
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
About the trial
What the trial wants to find out
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)
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Tests NX-5948 in adults with relapsed chronic lymphocytic leukemia or lymphomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 24 August 2026