Table 6.

Acalabrutinib clinical studies in patients with CLL or SLL.

Clinical Study	Type of Study	Eligible Patients	Treatment	Endpoint	Conclusion	Refs.
ELEVATE-TN	Phase III, randomized, controlled.	Untreated patients aged ≥ 65 years.	Acalabrutinib + obinutuzumab, acalabrutinib or obinutuzumab + chlorambucil	PFS	Acalabrutinib, or acalabrutinib + obinutuzumab, demonstrated a significant enhancement in PFS compared to obinutuzumab + chlorambucil. Consider acalabrutinib monotherapy or in combination with obinutuzumab as treatment in naïve patients.	[123]
ASCEND	Phase III, randomized, open label, multicenter.	Patients aged ≥ 18 years diagnosed with CLL who had undergone at least one systemic therapy before.	Acalabrutinib, Idelasib + rituximab (idR) or BR	PFS	Meaningful enhancement in PFS when comparing acalabrutinib monotherapy to IdR or BR treatment regimens. Acalabrutinib demonstrated tolerability and profile. These results support the use of acalabrutinib monotherapy as a treatment for patients with r/r CLL, including those presenting high risk.	[124,125]
ELEVATE R/R	Phase III, randomized, international. multicenter, open label, non-inferiority.	Individuals who had undergone at least one previous therapy. ECOG ≤ 2 del(17) (p13.1) and/or del(11).	Acalabrutinib vs. ibrutinib	PFS	Acalabrutinib exhibited non-inferiority to ibrutinib in terms of PFS. There was a statistically significant reduction in the incidence of atrial fibrillation/flutter with acalabrutinib in patients with previously treated CLL. The incidence of hypertension was higher with ibrutinib.	[126]
MAJIC	Phase III, prospective, multicenter, randomized, open label.	Adults with naïve CLL/SLL meeting indication for treatment.	Acalabrutinib + venetoclax (AV) vs. VO	PFS	Evaluation to see if MRD-guided limited AV treatment is comparable to MRD-guided limited VO treatment in terms of PFS. The study is still in progress.	[127]