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 refers to acalabrutinib given at 100 mg twice daily in combination with allogeneic hematopoietic stem cell transplantation. It is an investigational strategy studied in patients with chronic lymphocytic leukemia and mantle cell lymphoma who undergo alloSCT. The combination has been evaluated in a single Phase 2 trial.
It is used for chronic lymphocytic leukemia in patients who are subjected to allogeneic hematopoietic stem cell transplantation. The Phase 2 study also enrolled patients with mantle cell lymphoma and assessed chronic graft-versus-host disease, adverse events, and response rate as conditions of interest.
Acalabrutinib targets Bruton tyrosine kinase, or BTK, and acts as a BTK inhibitor. BTK is a kinase involved in B-cell receptor signaling. In this regimen the BTK inhibitor is combined with allogeneic hematopoietic stem cell transplantation rather than given as monotherapy.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of acalabrutinib, the small molecule BTK inhibitor used in this combination with allogeneic hematopoietic stem cell transplantation. The regimen itself is the studied combination of the drug plus the transplant procedure.
It is in Phase 2 development. The single trial evaluating acalabrutinib with allogeneic hematopoietic stem cell transplantation is a completed Phase 2 study, so the combination is investigational and has not been approved for this use. The study was uncontrolled, non-randomized, and not blinded.
NCT04716075 is the Phase 2 trial titled Acalabrutinib in CLL and MCL Patients Subjected to Allogeneic Hematopoietic Stem Cell Transplantation. It enrolled 29 patients aged 18 years and older in Poland, allowed both sexes, excluded healthy volunteers, and is now completed.