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ACALABRUTINIB · 1 trial · 13 indications
The CRR is defined as the percentage of subjects achieving an objective response of complete response (CR) according to the Lugano Classification (Chesson et al., 2014), prior to start of another non-study anticancer therapy. CR is defined as a complete metabolic and radiologic response (Lugano score 1-3, target nodes/nodal masses must regress to ≤ 1.5 cm in longest diameter.)
| Arm | Type | Description |
|---|---|---|
| ACALABRUTINIB and LISOCABTAGENE MARALEUCEL | EXPERIMENTAL | The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, as tolerated for one year * Liso-cel * Acalabrutinib |
| Name | Type | Description |
|---|---|---|
| ACALABRUTINIB | DRUG | Oral, twice daily, timing and dosage per protocol |
| LISOCABTAGENE MARALEUCEL | DRUG | via IV timings and dosage per protocol |
| Lymphodepleting chemotherapy | DRUG | lymphodepleting chemotherapy with cyclophosphamide and fludarabine once a day for 3 days via IV about 2-4 hours. This will occur only once prior to lisocabtagene maraleucel infusion. |
Inclusion Criteria: * Adult patients ≥18 years with histologically confirmed aggressive B-cell NHL including diffuse large B-cell lymphoma (DLBCL), either de novo or transformed from any indolent B-cell lymphoma, and including DLBCL NOS, T cell/histiocyte-rich large B-cell lymphoma, Epstein-Barr vi...
Acalabrutinib is being studied for the treatment of refractory aggressive B-cell lymphomas, including refractory B-cell non-Hodgkin lymphoma, diffuse large B-cell lymphoma (DLBCL), and other aggressive subtypes. It is currently in Phase 2 clinical development as an investigational therapy for these conditions.
Acalabrutinib targets Bruton's tyrosine kinase (BTK) and acts as a BTK inhibitor. By inhibiting BTK, it interferes with B-cell receptor signaling, which is relevant in the treatment of B-cell malignancies such as refractory aggressive B-cell lymphomas.
Acalabrutinib is being developed by Johnson & Johnson (ticker: JNJ). The company is conducting clinical trials to evaluate the drug as a treatment for refractory aggressive B-cell lymphomas.
Acalabrutinib is in Phase 2 clinical development for refractory aggressive B-cell lymphomas. It is an investigational drug and has not been approved by the FDA for this indication. The ongoing trial is active but not recruiting participants.
Acalabrutinib is being evaluated in a Phase 2 clinical trial with the identifier NCT05583149, titled 'Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas.' This single-arm, uncontrolled study is enrolling 28 participants in the United States and is currently active but not recruiting.
No, acalabrutinib is not the same as liso-cel. Acalabrutinib is a small molecule BTK inhibitor, while liso-cel is a CAR-T cell therapy. The two are being studied in combination in the clinical trial NCT05583149 for refractory aggressive B-cell lymphomas.