Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Acalabrutinib · 1 trial · 1 indication
Measured according to Lugano criteria. A success is defined as a CMR as the objective status at the end of treatment. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. 9% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
| Arm | Type | Description |
|---|---|---|
| Treatment (modified VR-CAP, acalabrutinib) | EXPERIMENTAL | CYCLES 1, 3, AND 5: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive bortezomib SC on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) IV, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5. CYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Acalabrutinib | DRUG | Given PO |
| Bortezomib | DRUG | Given SC |
| Cyclophosphamide | DRUG | Given IV |
| Cytarabine | DRUG | Given IV |
| Doxorubicin Hydrochloride | DRUG | Given IV |
| Prednisone | DRUG | Given PO |
| Rituximab | BIOLOGICAL | Given IV |
| Rituximab and Hyaluronidase Human | BIOLOGICAL | Given IV |
Inclusion Criteria: * Age 18-75 years * No prior therapy for mantle cell lymphoma (MCL) * MCL in need of systemic therapy, and potentially eligible for ASCT as assessed by the treating physician * Documented histological confirmation of MCL by local institutional review * Documented, fludeoxyglucos...
Acalabrutinib is an investigational small molecule being studied for the treatment of Mantle Cell Lymphoma. It is currently in Phase 2 clinical development as part of a first-line therapy regimen for transplant-eligible patients with this condition. The drug is being evaluated in combination with modified VR-CAP chemotherapy.
Acalabrutinib is a kinase inhibitor, as indicated by its -tinib suffix. It belongs to the target class of kinase inhibitors. The drug is being studied for its role in treating Mantle Cell Lymphoma, where it is combined with modified VR-CAP as first-line therapy for transplant-eligible patients.
Acalabrutinib is being developed by United Therapeutics Corporation, which trades under the ticker symbol UTHR. The company is conducting a Phase 2 clinical trial of the drug in Mantle Cell Lymphoma. This trial is currently recruiting participants in the United States.
Acalabrutinib is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is studying the drug as first-line therapy for transplant-eligible patients with Mantle Cell Lymphoma, with an enrollment target of 45 participants.
Acalabrutinib is being studied in one active clinical trial, NCT04626791. This Phase 2 trial is titled 'Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma.' The trial is recruiting in the United States and is not randomized or blinded.
Acalabrutinib is the drug name used in the clinical trial NCT04626791. No alternative names have been reported for this drug in the available information. It is being studied as a single agent within a combination regimen for Mantle Cell Lymphoma, and no other names are associated with it.