Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab
Condition(s) studied
Investigational drug(s) / intervention(s)
Acalabrutinib: Acalabrutinib is an orally available cBTKi that inhibits the activity of BTK and prevents the activation of the B-cell antigen receptor (BCR) signaling pathway.
Venetoclax: Venetoclax is an orally bioavailable inhibitor of the anti-apoptotic protein BCL-2
Study summary
This study will evaluate the efficacy and safety of finite-duration acalabrutinib plus venetoclax therapy in patients with relapsed CLL or SLL, and have previously responded to first line (1L) cBTKi + BCL2i therapy (± obinutuzumab) and maintained a response for at least two years post-treatment.
Eligibility
Primary outcome measure(s)
- Overall Response Rate (ORR) — ORR assessed at multiple timepoints during treatment period (each cycle is 28 days). Timepoint for primary analysis is at completion of cycle 14
ORR, defined as the proportion of participants who achieve best response of CR, CRi, nPR, or PR per iwCLL criteria as assessed by the investigator.
Trial sites (36)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Boston | Massachusetts | Recruiting |
| Research Site | Charlotte | North Carolina | Withdrawn |
| Research Site | Charlotte | North Carolina | Recruiting |
| Research Site | Durham | North Carolina | Recruiting |
| Research Site | Winston-Salem | North Carolina | Recruiting |
| Research Site | Horn | Austria | Recruiting |
| Research Site | Goiânia | Brazil | Not Yet Recruiting |
| Research Site | Porto Alegre | Brazil | Not Yet Recruiting |
| Research Site | Porto Alegre | Brazil | Not Yet Recruiting |
| Research Site | São Paulo | Brazil | Not Yet Recruiting |
| Research Site | São Paulo | Brazil | Not Yet Recruiting |
| Research Site | Brno | Czechia | Not Yet Recruiting |
| Research Site | Hradec Kralova | Czechia | Not Yet Recruiting |
| Research Site | Ostrava | Czechia | Not Yet Recruiting |
| Research Site | Dublin | Ireland | Recruiting |
| Research Site | Dublin | Ireland | Recruiting |
| Research Site | Meldola | Italy | Recruiting |
| Research Site | Milan | Italy | Withdrawn |
| Research Site | Milan | Italy | Not Yet Recruiting |
| Research Site | Padua | Italy | Recruiting |
| Research Site | Ravenna | Italy | Recruiting |
| Research Site | Rome | Italy | Withdrawn |
| Research Site | Torino | Italy | Withdrawn |
| Research Site | Bydgoszcz | Poland | Not Yet Recruiting |
| Research Site | Krakow | Poland | Withdrawn |
| Research Site | Lodz | Poland | Withdrawn |
| Research Site | Lublin | Poland | Not Yet Recruiting |
| Research Site | Warsaw | Poland | Not Yet Recruiting |
| Research Site | Warsaw | Poland | Not Yet Recruiting |
| Research Site | Barcelona | Spain | Recruiting |
| Research Site | Barcelona | Spain | Not Yet Recruiting |
| Research Site | Granada | Spain | Recruiting |
| Research Site | Madrid | Spain | Recruiting |
| Research Site | Madrid | Spain | Recruiting |
| Research Site | Madrid | Spain | Not Yet Recruiting |
| Research Site | Majadahonda | Spain | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07024706 on ClinicalTrials.gov ↗ ← All trials in Spain