Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Acalabrutinib · 1 trial · 4 indications
The CR Rate is defined as the proportion of participants achieving complete remission (CR) based on 2018 IW-CLL criteria.
| Arm | Type | Description |
|---|---|---|
| Cohort 1-Relapsed Disease | EXPERIMENTAL | Participants with relapsed disease * Treatment with Acalabrutinib \& Umbralisib beginning C1D1, * Ublituximab beginning C7D1 * Assessment of treatment response * Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years |
| Cohort 2-Treatment Naive | EXPERIMENTAL | Participants with previously untreated disease * Treatment with Acalabrutinib \& Umbralisib beginning C1D1, * Ublituximab beginning C7D1 * Assessment of treatment response * Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years |
| Name | Type | Description |
|---|---|---|
| Acalabrutinib | DRUG | Oral, twice a day, predetermined dosage |
| Umbralisib | DRUG | Oral, once a day, predetermined dosage, each 28 day cycle up to 24 cycles |
| Ublituximab | DRUG | 28 day cycle, starting cycle 7 via iv, on at predetermined dosage and timepoints in each cycle |
Inclusion Criteria: * Confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) per International Workshop on CLL (iwCLL) 2018 criteria.1 * Participants must have an indication for treatment as defined by iwCLL 2018 criteria.1 * Participants must have measurable ...
Acalabrutinib is an investigational small molecule being studied for the treatment of Chronic Lymphocytic Leukemia (CLL). It is currently in Phase 2 clinical development, evaluated in combination with umbralisib and ublituximab for patients with relapsed, refractory, or untreated CLL.
Acalabrutinib is a kinase inhibitor, belonging to the -tinib class of drugs. It is being studied for its role in targeting kinases involved in cancer cell signaling, specifically in the context of Chronic Lymphocytic Leukemia.
Acalabrutinib is being developed by TG Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TGTX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Chronic Lymphocytic Leukemia.
Acalabrutinib is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing trial is active but not recruiting participants, with a total enrollment of 29 patients.
Acalabrutinib is being studied in a Phase 2 clinical trial with the identifier NCT04624633. The trial, titled 'Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL,' is enrolling patients with Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and relapsed or refractory CLL in the United States.
Acalabrutinib is not the same as AU2. AU2 is the name of the combination regimen being studied in the clinical trial, which includes acalabrutinib, umbralisib, and ublituximab. Acalabrutinib is one component of this three-drug combination being evaluated for Chronic Lymphocytic Leukemia.