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NCT04941716
Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, The AVENUE-2 Trial
Phase 2 trial testing Acalabrutinib in Recurrent Chronic Lymphocytic Leukemia in 20 participants. Currently enrolling.
10 August 2027
Quick facts
| Lead sponsor | Fred Hutchinson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 31 May 2023 |
| Primary completion | 10 August 2027 |
| Estimated completion | 10 August 2031 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Acalabrutinib (ACALABRUTINIB) — full drug profile →
- Venetoclax (venetoclax) — full drug profile →
- Biospecimen Collection — full drug profile →
- Bone Marrow Aspiration — full drug profile →
- Bone Marrow Biopsy
- Computed Tomography
- Magnetic Resonance Imaging
Conditions studied
- Recurrent Chronic Lymphocytic Leukemia — all drugs for Recurrent Chronic Lymphocytic Leukemia →
- Recurrent Small Lymphocytic Lymphoma — all drugs for Recurrent Small Lymphocytic Lymphoma →
- Refractory Chronic Lymphocytic Leukemia — all drugs for Refractory Chronic Lymphocytic Leukemia →
- Refractory Small Lymphocytic Lymphoma — all drugs for Refractory Small Lymphocytic Lymphoma →
Sponsor
Fred Hutchinson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Recurrent Chronic Lymphocytic Leukemia or Recurrent Small Lymphocytic Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase II trial is to evaluate the effects of acalabrutinib in combination with venetoclax in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that does not respond to treatment (refractory) or that has come back (recurrent). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Given acalabrutinib and venetoclax may kill more cancer cells.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
MRD-directed therapy in CLL: ready for prime time?
Rhodes JM, Lopez CA, Barrientos JC. · · 2023 · cited 7× · PMID 38066928 · DOI 10.1182/hematology.2023000441 -
The role of MRD monitoring and options for CLL management in relapsed/refractory disease.
Sworder B, Siddiqi T. · · 2025 · PMID 41348036 · DOI 10.1182/hematology.2025000685
Verify or expand the search:
- PubMed search for NCT04941716
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Acalabrutinib
Trials testing the same drug.
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- NCT07024706 — Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2 · Phase 2 · not yet recruiting
- NCT07283965 — Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies · not yet recruiting
- NCT07014917 — Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL · Phase 2 · recruiting
Other recruiting trials for Recurrent Chronic Lymphocytic Leukemia
Currently open trials in the same condition.
- NCT07061951 — Testing the Effectiveness of the Anti-cancer Drug, Mirdametinib, in Treating Relapsed, Refractory Chronic Lymphocytic Le · Phase 2 · recruiting
- NCT07166419 — Anti-CD19/20/22 Chimeric Antigen Receptor T Cells (TriCAR19.20.22 T Cells) for the Treatment of Relapsed or Refractory N · Phase 1 · recruiting
- NCT06712810 — Q702 for the Treatment of Patients With Hematologic Malignancies · Phase 1 · recruiting
- NCT06839053 — Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic L · Phase 2 · recruiting
- NCT06191887 — B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide · Phase 1 · recruiting
Other Fred Hutchinson Cancer Center trials
Trials by the same sponsor.
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- NCT07493252 — A Behavioral Application for Improving Smoking Cessation Among Smokers · NA · not yet recruiting
- NCT07490860 — A Restorative Justice-Based Lung Cancer Screening Decision-Making Support Intervention Tailored for Black Individuals to · NA · not yet recruiting
- NCT07194980 — Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small L · Phase 2 · not yet recruiting
- NCT07176000 — Tailored Patient Navigation to Improve the Uptake of Lung Cancer Screening in Tribal Communities in Western Washington S · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04941716 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fred Hutchinson Cancer Center
- Last refreshed: 19 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04941716.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing