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Clinical Trials in Austria / NCT07024706
Recruiting Phase 2

Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab

NCT07024706 · tracked via the Priya Life Science Austria tracker
Phase
Phase 2
Started
2026-06-04
Last updated
2026-08-06

Condition(s) studied

Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)

Investigational drug(s) / intervention(s)

Acalabrutinib →Venetoclax →

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

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Main Inclusion Criteria: 1. Participant must be ≥ 18 years at the time of signing informed consent. 2. Diagnosis of CLL/SLL according to iwCLL guidelines 2018 (Hallek et al. 2018) 3. Participants must have received first line treatment with fixed duration covalent BTKi plus BCL2i therapy (± obinutuzumab) with a response ≥ PR (i.e., CR, CRi, nPR, or PR) with a minimum of 2 years since the end of the prior 1L treatment. 4. The following data must be available or at least the appropriate samples drawn/acquired prior to dosing: 1. IGHV (mutated vs. unmutated) 2. del(17p) (present or absent) 3. TP53 mutation (present or absent) 5. ECOG performance status 0, 1 or 2 6. Adequate organ and bone marrow (BM) function. Main Exclusion Criteria: 1. Any evidence of diseases that, in the investigator's opinion, makes it undesirable for patient to participate in the study. 2. Significant cardiovascular or cerebrovascular disease. 3. Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease). 4. Child-Pugh B/C liver cirrhosis. 5. History of prior or current malignancy. 6. HIV positive 7. History of progressive multifocal leukoencephalopathy (PML). 8. Active hepatitis B or C infection: 9. Corticosteroid use \> 20 mg within 1 week before the first dose of study intervention. 10. History of hypersensitivity or anaphylaxis to study intervention(s). 11. Requires treatment with a strong CYP3A4 inhibitor/inducer. 12. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists. 13. Major surgical procedure within 30 days of the first dose of study intervention.

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
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

On this site

📄 Calquence (acalabrutinib) drug profile → 📄 Venclexta (venetoclax) drug profile →

More AstraZeneca trials in Austria

Other trials for the same condition

Official registry record

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 Austria