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 used for chronic lymphocytic leukemia (CLL). It is being studied in patients with CLL who undergo allogeneic hematopoietic stem cell transplantation (alloSCT). The drug is also being evaluated for related conditions including chronic graft-versus-host disease and mantle cell lymphoma.
Acalabrutinib 2x+ alloSCT is developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical research on this small molecule drug for oncology indications.
Acalabrutinib 2x+ alloSCT is in Phase 2 clinical development. It has received Priority Review designation from the FDA. The drug is investigational and still in clinical development, not yet approved for commercial use.
Acalabrutinib 2x+ alloSCT has one completed clinical trial, NCT04716075, titled "Acalabrutinib in CLL and MCL Patients Subjected to Allogeneic Hematopoietic Stem Cell Transplantation (alloSCT)". This Phase 2 study enrolled 29 participants in Poland and included patients aged 18 years and older.
Acalabrutinib 2x+ alloSCT is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The FDA has granted it Priority Review designation, but the drug remains under study and has not received marketing approval.