NCT07024706 Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab
| NCT ID | NCT07024706 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | AstraZeneca |
| Condition | Chronic Lymphocytic Leukemia (CLL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-06-04 |
| Primary Completion | 2029-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2026-06-04 with a primary completion date of 2029-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07024706 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 130 Years, studying Chronic Lymphocytic Leukemia (CLL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07024706 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07024706 currently recruiting?
Yes, NCT07024706 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07024706 trial being conducted?
This trial is being conducted at Boston, United States, Charlotte, United States, Charlotte, United States, Durham, United States and 11 additional locations.
Who is sponsoring the NCT07024706 clinical trial?
NCT07024706 is sponsored by AstraZeneca. The trial plans to enroll 80 participants.
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