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, and in combination with Treanda (bendamustine) and Rituxan (rituximab) in patients with untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Acalabrutinib | Calquence | ACP-196 | BTK inhibitor 38 | 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, and in combination with Treanda (bendamustine) and Rituxan (rituximab) in patients with untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| 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... |
| 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... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT04548648 | Phase II | Acalabrutinib Isavuconazole | LCCC1841: A Phase 2 Trial of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas | 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 |
| 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 |
| 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 |
| 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 |
| NCT03736616 | Phase II | Acalabrutinib Carmustine + Cytarabine + Etoposide + Melphalan Acalabrutinib + Carboplatin + Etoposide + Ifosfamide + Rituximab | Acalabrutinib Plus RICE for Relapsed/Refractory DLBCL | Unknown status | 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 | SWE | SVK | POL | NZL | ITA | ISR | HUN | HRV | GBR | FRA | ESP | DEU | CZE | CAN | BGR | BEL | AUT | AUS | 6 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT06757647 | Phase II | Acalabrutinib | Acalabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Not yet recruiting | 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 |
| NCT05256641 | Phase Ib/II | Acalabrutinib | Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma | Recruiting | 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 |
| NCT02537444 | Phase II | Acalabrutinib Pembrolizumab | ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Recurrent Ovarian Cancer (KEYNOTE191) | Completed | USA | 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 |
| NCT04189757 | Phase II | Acalabrutinib | Acalabrutinib for the Treatment of Ibrutinib-Intolerant Mantle Cell Lymphoma | Active, not recruiting | 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 |
| NCT04402138 | Phase II | Acalabrutinib | Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma | Completed | USA | 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 |
| 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 | 12 |
| NCT04660045 | Phase II | Acalabrutinib | Early Intervention With Acalabrutinib in Patients With High Risk CLL | Withdrawn | 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 |
| 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 |
| NCT02362048 | Phase II | Acalabrutinib Pembrolizumab | ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic 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 |
| NCT02337829 | Phase II | Acalabrutinib | ACP-196 in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL | Active, not recruiting | USA | 0 |
| NCT04906902 | Phase Ib/II | Acalabrutinib | Acalabrutinib in CNSL | Recruiting | USA | 0 |
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