Approval Probability
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ML Risk
Also known as Acalabrutinib, acalabrutinib
Acalabrutinib+ R-CHOP standard of care · 1 trial · 1 indication
Investigator-assessed best ORR (CR+PR) as per the Lugano Classification for NHL
| Arm | Type | Description |
|---|---|---|
| Single Arm | EXPERIMENTAL | Acalabrutinib + R-CHOP standard of care (Induction Phase) plus Acalabrutinib + Rituximab (Maintenance Phase) / Acalabrutinib Monotherapy (Maintenance Phase) |
| Name | Type | Description |
|---|---|---|
| Acalabrutinib + R-CHOP standard of care | DRUG | Acalabrutinib will be administered 100 mg twice per day (BID) orally (PO) until disease progression if medically appropriate, along with R-CHOP standard of care up to six 21-day cycles of the induction phase. |
| Acalabrutinib combination with Rituximab | DRUG | If the subject achieves response during the induction phase, acalabrutinib will be administered 100 mg BID PO until disease progression and rituximab 375 mg/m2 on Day 1 of every other 28-day cycle for a maximum of 12 additional doses. |
| Acalabrutinib monotherapy | DRUG | If the subject does not achive response during the induction phase, monotherapy acalabrutinib will be administered 100 mg BID PO until disease progression. |
INCLUSION CRITERIA: 1. Adult men or women. 2. Pathologically confirmed MCL, with documentation of chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers. 3. MCL requiring treatment and for which no prior systemic anticancer therapies...
Acalabrutinib is an investigational small molecule being studied for mantle-cell lymphoma, chronic lymphocytic leukemia, advanced B-cell malignancies, B-cell non-Hodgkin lymphoma, non-Hodgkin lymphoma, and infectious disease. It is also being evaluated in Richter syndrome and COVID-19. The drug is in clinical development and has not been approved for these uses.
Acalabrutinib is a kinase inhibitor, belonging to the -tinib class of drugs. It targets and inhibits Bruton's tyrosine kinase (BTK), a protein involved in B-cell receptor signaling. By blocking this kinase, acalabrutinib is intended to disrupt the survival and proliferation of malignant B cells.
Acalabrutinib is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the drug's safety and efficacy across multiple oncology and infectious disease indications.
Acalabrutinib is in Phase 1 clinical development. It has received priority review designation from the FDA. The drug is investigational and has not been approved for any indication. Clinical trials are ongoing to assess its potential as a treatment for various B-cell malignancies and other conditions.
Acalabrutinib is being studied in several clinical trials. NCT02180711 is a Phase 1 study in B-cell non-Hodgkin lymphoma. NCT03899337 is a Phase 2 trial in Richter syndrome. NCT04346199 and NCT04380688 are Phase 2 studies in hospitalized COVID-19 patients. These trials are active or completed, with a total enrollment of over 1,500 participants.
Acalabrutinib is the same drug as Acalabrutinib in combination with BR and Acalabrutinib + R-CHOP standard of care. These names refer to acalabrutinib when used alongside specific chemotherapy regimens, such as bendamustine and rituximab (BR) or R-CHOP, in clinical trial settings.