Therapy Detail

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Therapy Name Acalabrutinib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Acalabrutinib Calquence ACP-196 BTK inhibitor 25 Calquence (acalabrutinib) selectively inhibits BTK, resulting in decreased B-cell receptor signaling, and potentially leading to decreased tumor cell proliferation (PMID: 27903679, PMID: 26957112). Calquence (acalabrutinib) is FDA approved for use in patients with mantle cell lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
TP53 mutant CLL/SLL sensitive Acalabrutinib Guideline Actionable Calquence (acalabrutinib) is indicated in the guidelines as second line and subsequent therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with a TP53 mutation (NCCN.org). detail...
Unknown unknown chronic lymphocytic leukemia not applicable Acalabrutinib Phase Ib/II Actionable In a Phase Ib/II clinical trial, Calquence (acalabrutinib) treatment in chronic lymphocytic leukemia patients, including patients carrying chromosome 17p13.1 deletion, resulted in a 95% (57/60) overall response rate, which consisted of 85% with partial response and 5% (3/60) with stable disease (PMID: 26641137). 26641137
Unknown unknown chronic lymphocytic leukemia not applicable Acalabrutinib FDA approved Actionable In a Phase III trial (ELEVATE TN) that supported FDA approval, Calquence (acalabrutinib) treatment resulted in prolonged progression-free survival compared to Gazyva (obinutuzumab) plus chlorambucil (HR=0.20, p<0.0001) in patients with treatment-naive chronic lymphocytic leukemia (PMID: 31724010; NCT02475681). 31724010 detail...
Unknown unknown mantle cell lymphoma not applicable Acalabrutinib Phase II Actionable In a Phase II trial (ACE-LY-004) that supported FDA approval, Calquence (acalabrutinib) treatment resulted in an overall response rate of 81% (100/124, 49 complete response) in patients with relapsed or refractory mantle cell lymphoma (PMID: 29241979; NCT02213926). 29241979 detail...
TP53 loss CLL/SLL sensitive Acalabrutinib Guideline Actionable Calquence (acalabrutinib) is indicated in the guidelines as second line and subsequent therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with TP53 loss (NCCN.org). detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04189757 Phase II Acalabrutinib Acalabrutinib for the Treatment of Ibrutinib-Intolerant Mantle Cell Lymphoma Recruiting USA 0
NCT02477696 Phase III Acalabrutinib Ibrutinib Elevate CLL R/R: Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia Active, not recruiting USA 14
NCT02029443 Phase Ib/II Acalabrutinib ACP-196, a Novel Bruton Tyrosine Kinase (Btk) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia Active, not recruiting USA 2
NCT02362035 Phase Ib/II Acalabrutinib Pembrolizumab ACP-196 in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies (KEYNOTE145) Active, not recruiting USA 0
NCT04008706 Phase III Acalabrutinib Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients (ASSURE) Recruiting USA | CAN 15
NCT02213926 Phase II Acalabrutinib An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma Active, not recruiting USA 1
NCT02586857 Phase Ib/II Acalabrutinib A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM) Active, not recruiting USA 0
NCT02717611 Phase II Acalabrutinib A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy Active, not recruiting USA 5
NCT02475681 Phase III Acalabrutinib Chlorambucil Obinutuzumab Elevate CLL TN: Study of Obinutuzumab + Chlorambucil, ACP-196 + Obinutuzumab, and ACP-196 in Subjects With Previously Untreated CLL Active, not recruiting USA | CAN 16
NCT03516617 Phase II Acalabrutinib Acalabrutinib + Obinutuzumab Acalabrutinib With or Without Obinutuzumab in Treating Participants With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Recruiting USA 0
NCT02180724 Phase I Acalabrutinib An Open-label, Phase 1b Study of ACP 196 in Subjects With Waldenström Macroglobulinemia Active, not recruiting USA 2
NCT02211014 Phase I Acalabrutinib Dexamethasone An Open-Label, Phase 1b Study of ACP-196 With and Without Dexamethasone in Subjects With Multiple Myeloma Completed USA 1
NCT04548648 Phase II Acalabrutinib Isavuconazole LCCC1841: A Phase 2 Trial of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas Not yet recruiting USA 0
NCT02337829 Phase II Acalabrutinib ACP-196 in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL Active, not recruiting USA 0
NCT02454179 Phase II Pembrolizumab Acalabrutinib Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Advanced Head and Neck Squamous Cell Carcinoma Completed USA 0
NCT02448303 Phase II Acalabrutinib Pembrolizumab Pembrolizumab Alone and In Combination With ACP-196 in Subjects With Advanced Non-small Cell Lung Cancer Completed USA 0
NCT04402138 Phase II Acalabrutinib Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma Recruiting USA 0
NCT02362048 Phase II Acalabrutinib Pembrolizumab ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer Completed USA 0
NCT04657094 Phase II Acalabrutinib Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia Recruiting USA 0
NCT03736616 Phase II Acalabrutinib Carmustine + Cytarabine + Etoposide + Melphalan Acalabrutinib + Carboplatin + Etoposide + Ifosfamide + Rituximab Acalabrutinib Plus RICE for Relapsed/Refractory DLBCL Recruiting USA 0
NCT04662255 Phase III Ibrutinib Zanubrutinib LOXO-305 Acalabrutinib Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) (BRUIN-MCL-321) Recruiting USA 0
NCT02970318 Phase III Bendamustine + Idelalisib + Rituximab Acalabrutinib A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL Active, not recruiting USA | CAN 23
NCT02570711 Phase II Acalabrutinib Gemcitabine + Nab-paclitaxel Study of Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Previously Untreated Metastatic Pancreatic Cancer Terminated USA 0
NCT04660045 Phase II Acalabrutinib Early Intervention With Acalabrutinib in Patients With High Risk CLL Not yet recruiting USA 0
NCT02180711 Phase I Acalabrutinib An Open-label, Phase 1b Study of ACP 196 in Subjects With Follicular Lymphoma Recruiting USA 0
NCT02328014 Phase Ib/II ACP-319 Acalabrutinib ACP-196 in Combination With ACP-319, for Treatment of B-Cell Malignancies Active, not recruiting USA 0
NCT02537444 Phase II Acalabrutinib Pembrolizumab ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Recurrent Ovarian Cancer (KEYNOTE191) Completed USA 0
NCT02351739 Phase II Pembrolizumab Acalabrutinib Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum-refractory Metastatic Bladder Cancer Completed USA 0


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