Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Acalabrutinib 2x+ alloSCT · 1 trial · 5 indications
Nr of patients with partial and complete response (PR and CR),
Nr of patients with minimum residual disease CR (MRD CR) assessed by flow cytometry in peripheral blood (PB) and bone marrow (BM)
Incidence of adverse events per system
| Arm | Type | Description |
|---|---|---|
| Acalabrutinib 2x100mg oral capsule +alloSCT | EXPERIMENTAL | Acalabrutinib administered 2x100mg p.o. daily for 3-6 months before alloSCT +acalabrutinib administered 2x100mg p.o. daily for 9 months after alloSCT |
| Name | Type | Description |
|---|---|---|
| Acalabrutinib 2x100 MG Oral Capsule + alloSCT | DRUG | Acalabrutinib 100 mg caps will be administered twice daily for 3-6 months before the intended alloSCT. After restarting acalabrutinib (2x100 mg daily) after the transplant procedure it will be administered for further 9 months. In patients who do not have an acceptable donor acalabrutinib will be administered until disease progression or unacceptable toxicity. |
Inclusion Criteria: 1. Men and women ≥ 18 years of age. 2. Relapsing / refractory BTK-inhibitors naïve CLL patients meeting IWCCL criteria for requiring treatment: 1. after 1-4 therapy lines if del 17 or p53 mutation in \>10% of analyzed CLL cells (PB or BM) or 2. after 2-4 therapy lines if ...
Acalabrutinib 2x+ alloSCT is a treatment approach studied in chronic lymphocytic leukemia, where acalabrutinib is given at 100 mg twice daily alongside allogeneic hematopoietic stem cell transplantation. The Phase 2 trial also enrolled patients with mantle cell lymphoma and evaluated chronic graft-versus-host disease, adverse events, and response rate.
Acalabrutinib, the small molecule component of this regimen, targets Bruton tyrosine kinase, or BTK. It is a BTK inhibitor. The alloSCT component is a procedure rather than a drug, so the molecular target applies to acalabrutinib itself, which acts on BTK signaling in B-cell malignancies such as chronic lymphocytic leukemia.
AstraZeneca PLC, which trades under the ticker AZN, is the developer associated with this acalabrutinib plus allogeneic stem cell transplant regimen. The company is the sponsor behind the clinical program evaluating the twice-daily 100 mg oral capsule dose in combination with alloSCT.
Acalabrutinib 2x+ alloSCT is in Phase 2 development. The single registered trial, NCT04716075, has completed and enrolled 29 patients. It is an investigational regimen and is not described as approved. The program has received a priority review designation.
Acalabrutinib 2x+ alloSCT has been studied in one Phase 2 trial, NCT04716075, titled Acalabrutinib in CLL and MCL Patients Subjected to Allogeneic Hematopoietic Stem Cell Transplantation. The trial completed with 29 participants, was conducted in Poland, enrolled adults 18 years and older, and was uncontrolled and non-randomized.