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Taking people in ItalyPhase 3

Compares tacabrutideg with pirtobrutinib in relapsed leukemia or lymphoma

Compares tacabrutideg with pirtobrutinib in adults with CLL or SLL that returned after treatment.

Key facts

Who runs it
BeOne Medicines
Where
Bologna, Milan, and Padova, ItalySee the 4 sitesAlso in 23 other countries, 213 sites
Registry title
A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Status
Recruiting
Phase
Phase 3
People taking part
500 people, planned
Started
4 Sept 2025
Expected to end
17 Apr 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Tacabrutideg
  • Pirtobrutinib
Record updated
28 September 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 with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that came back or did not respond after treatment with a covalent BTK inhibitor.

Age
18 years or older
Sex
All sexes can join
Disease stage
CLL or SLL that needs treatment. The disease came back after, or did not respond to, at least 1 earlier treatment that included a covalent BTK inhibitor (cBTKi). People with SLL need measurable disease on a CT or MRI scan: at least 1 lymph node larger than 1.5 cm (0.6 in) in its longest diameter, measurable in 2 perpendicular directions.
Earlier treatment
Must have had treatment with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Must not have had a BTK protein degrader or a noncovalent BTK inhibitor (ncBTKi).

Main reasons for not taking part

  • Prolymphocytic leukemia, or a history or suspicion of Richter's transformation
  • Known bleeding disorder, or past spontaneous bleeding needing a blood transfusion or other medical treatment
  • Ischemic stroke or bleeding inside the skull within 6 months before the first dose
  • Past treatment with a BTK protein degrader or a noncovalent BTK inhibitor
  • CLL or SLL in the central nervous system, now or in the past

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria
  • Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi
  • Participants with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters

Who cannot take part

  • History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
  • Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi)
  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  • History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
  • Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL; NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Where in Italy

Also in 23 other countries, 213 sites

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
  • ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
  • Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
  • Azienda Ospedaliera di PadovaPadova, ItalyTaking people

About the trial

What the trial wants to find out

The purpose of this study is to evaluate the efficacy and safety of tacabrutideg alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).

The 2 groups in the trial

  • Arm A: TacabrutidegTreatment being tested

    Participants will receive tacabrutideg orally.

    Treatment: Tacabrutideg

  • Arm B: PirtobrutinibExisting treatment, for comparison

    Participants will receive pirtobrutinib orally.

    Treatment: Pirtobrutinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Plain-language title
Compares tacabrutideg with pirtobrutinib in relapsed 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 12 November 2026.
Record updated
28 September 2026
Under construction, not live – A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT06973187) – Frontlight Research