Therapy Detail
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| Therapy Name | Acalabrutinib |
| Synonyms | |
| Therapy Description |
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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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Acalabrutinib | Calquence | ACP-196 | BTK inhibitor 37 | 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 | chronic lymphocytic leukemia | sensitive | Acalabrutinib | Guideline | Actionable | Calquence (acalabrutinib) is included in guidelines as preferred first-line therapy for patients with advanced chronic lymphocytic leukemia harboring TP53 mutations and for patients with relapsed or refractory disease (PMID: 38969011; ESMO.org). | 38969011 detail... |
| TP53 loss | chronic lymphocytic leukemia/small lymphocytic lymphoma | 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... |
| TP53 mutant | chronic lymphocytic leukemia/small lymphocytic lymphoma | 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... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04883749 | Phase II | Acalabrutinib | Efficacy of Acalabrutinib in Very Old or Frail Patients With Treatment-naïve or Relapsed/Refractory CLL (CLL-Frail) | Active, not recruiting | DEU | AUT | 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 | TUR | POL | NZL | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DNK | DEU | BEL | AUS | 0 |
| 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 | SWE | POL | NZL | LTU | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | 2 |
| NCT02362048 | Phase II | Acalabrutinib Pembrolizumab | ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer | Completed | USA | 0 |
| NCT04189757 | Phase II | Acalabrutinib | Acalabrutinib for the Treatment of Ibrutinib-Intolerant Mantle Cell Lymphoma | Active, not 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 |
| 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 |
| NCT02362035 | Phase Ib/II | Acalabrutinib Pembrolizumab | ACP-196 in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies (KEYNOTE145) | Active, not recruiting | USA | 0 |
| 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 | ISR | GBR | FRA | ESP | BEL | 0 |
| NCT02213926 | Phase II | Acalabrutinib | An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma | Active, not recruiting | USA | POL | NLD | ITA | GBR | FRA | ESP | CZE | BEL | AUS | 0 |
| 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 |
| NCT04178798 | Phase III | Acalabrutinib | Study to Investigate the Use of Acalabrutinib in the Treatment of Patients With Chronic Lymphocytic Leukemia | Unknown status | ESP | 0 |
| NCT02029443 | Phase Ib/II | Acalabrutinib | ACP-196, a Novel Bruton Tyrosine Kinase (Btk) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia | Active, not recruiting | USA | ITA | GBR | 0 |
| NCT04657094 | Phase II | Acalabrutinib | Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia | Active, not 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 |
| NCT03736616 | Phase II | Acalabrutinib Carmustine + Cytarabine + Etoposide + Melphalan Acalabrutinib + Carboplatin + Etoposide + Ifosfamide + Rituximab | Acalabrutinib Plus RICE for Relapsed/Refractory DLBCL | Unknown status | 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 |
| 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 | GBR | 0 |
| NCT04906902 | Phase Ib/II | Acalabrutinib | Acalabrutinib in CNSL | Recruiting | USA | 0 |
| NCT06651970 | FDA approved | Obinutuzumab Zanubrutinib Rituximab Acalabrutinib Venetoclax | Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure | Not yet recruiting | USA | POL | ITA | GBR | ESP | CZE | 0 |
| NCT04008706 | Phase III | Acalabrutinib | Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients (ASSURE) | Active, not recruiting | USA | SWE | NOR | NLD | ITA | GBR | FRA | FIN | ESP | DNK | DEU | CAN | BRA | AUS | 3 |
| 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 |
| NCT04402138 | Phase II | Acalabrutinib | Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma | Completed | USA | 0 |
| NCT05256641 | Phase Ib/II | Acalabrutinib | Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma | Recruiting | USA | 0 |
| NCT04548648 | Phase II | Acalabrutinib Isavuconazole | LCCC1841: A Phase 2 Trial of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas | 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 |
| NCT06520098 | Phase II | Ibrutinib Zanubrutinib Ibrutinib + Venetoclax Venetoclax + Zanubrutinib Acalabrutinib Acalabrutinib + Venetoclax | A Randomized Phase II Study Of Bruton Tyrosine Kinase Inhibitor With Or Without Venetoclax In Veterans With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (Benefit VA) | Not yet 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 | NLD | ITA | GRC | GBR | FRA | ESP | 0 |
| NCT06136559 | Phase III | Ibrutinib ARQ 531 Acalabrutinib | A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011) | Recruiting | USA | TUR | SWE | POL | NZL | NOR | ISR | GRC | GBR | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUS | 11 |
| 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 |
| NCT04662255 | Phase III | Ibrutinib Zanubrutinib Pirtobrutinib Acalabrutinib | Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) (BRUIN-MCL-321) | Active, not recruiting | USA | POL | NZL | NLD | ITA | ISR | IRL | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | 6 |
| NCT04660045 | Phase II | Acalabrutinib | Early Intervention With Acalabrutinib in Patients With High Risk CLL | Withdrawn | USA | 0 |
| NCT02180711 | Phase I | Acalabrutinib | An Open-label, Phase 1b Study of ACP 196 in Subjects With Follicular Lymphoma | Active, not recruiting | USA | ITA | CAN | 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 | SWE | SVK | POL | NZL | ITA | ISR | HUN | HRV | GBR | FRA | ESP | DEU | CZE | CAN | BGR | BEL | AUT | AUS | 6 |
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