Table 1.
Clinical trials of BTK inhibitors in human diseases beyond B cell malignancies that are currently registered at ClinicalTrials.gov.
| Diseases | Btk inhibitor | Phase | Trial Identifier |
|---|---|---|---|
| Hematological malignancies of myeloid cells and T cells | |||
| AML | |||
| prevention of relapse after conditioning/Allo-HCT | Ibrutinib | Phase II | NCT03267186 |
| refractory/relapsed FLT3 mutant | Ibrutinib (with conventional chemotherapy, | Phase II/III | NCT03642236 |
| with or or without FLT3 inhibitor) | |||
| Myelodysplastic syndrome | |||
| failed or refuse standard therapy | Ibrutinib (with Lenalidomide) | Phase I | NCT03359460 |
| higher risk patients | Ibrutinib (with Azacitidine) | Phase Ib | NCT02553941 |
| Mastocytosis | Ibrutinib | Phase II - terminated | NCT02415608 |
| T-cell lymphoma | |||
| relapsed and refractory | Ibrutinib | Phase I | NCT02309580 |
| T-cell prolymphocytic leukemia | |||
| relapsed and refractory | Ibrutinib (with Venetoclax) | Phase II | NCT03873493 |
| Solid tumors | |||
| Breast cancer | Ibrutinib (with MEDI4736) | Phase I/II | NCT02403271 |
| HER2-amplified metastatic | Ibrutinib (with Trastuzumab) | Phase I/II | NCT03379428 |
| Colorectal cancers, advanced, refractory | Ibrutinib (with Pembrolizumab) | Phase I/II | NCT03332498 |
| Gastrointestinal and genitourinary cancer, advanced | Ibrutinib (with everolimus, paclitaxel, | Phase I/II | NCT02599324 |
| docetaxel, pembrolizumab or cetuximab) | |||
| Glioblastoma | Ibrutinib | Phase I | NCT03535350 |
| recurrent | Acalabrutinib | Phase Ib/II | NCT02586857 |
| Head and neck squamous cell carcinoma | Acalabrutinib (with Pembrolizumab) | Phase II - completed | NCT02454179 |
| recurrent and/or metastatic | Ibrutinib (with Nivolumab or Cetuximab) | Phase II | NCT03646461 |
| Kidney cancer (previously treated, metastatic) | Ibrutinib (with Nivolumab) | Phase I/II | NCT02899078 |
| Lung cancer, non-small cell | Acalabrutinib (with Pembrolizumab) | Phase II - completed | NCT02448303 |
| Ibrutinib (with MEDI4736) | Phase I/II | NCT02403271 | |
| previously treated | Ibrutinib | Phase I/II | NCT02321540 |
| Melanoma | Ibrutinib (with Pembrolizumab) | Phase I | NCT03021460 |
| refractory metastatic | Ibrutinib | Phase II | NCT02581930 |
| Oesophagogastric carcinoma | Ibrutinib | Phase II | NCT02884453 |
| Ovarian cancer | Acalabrutinib | Phase II - completed | NCT02537444 |
| Pancreatic cancer | Ibrutinib (with MEDI4736) | Phase I/II | NCT02403271 |
| advanced or metastatic | Acalabrutinib | Phase II - complete | NCT02362048 |
| adenocarcinoma, metastatic | Ibrutinib (with Nab-paclitaxel | Phase III - completed | NCT02436668 |
| and Gemcitabine) | |||
| Ibrutinib (with Gemcitabine | Phase I/II - completed | NCT02562898 | |
| and Nab-Paclitaxel) | |||
| neuroendocrine tumors | Ibrutinib | Phase II - completed | NCT02575300 |
| Prostate cancer (localized) | Ibrutinib (as Neoadjuvant therapy) | Phase I/II | NCT02643667 |
| Urothelial carcinoma | Acalabrutinib (with Pembrolizumab) | Phase II - completed | NCT02351739 |
| Metastatic solid tumors | Ibrutinib (with Nivolumab) | Phase I | NCT03525925 |
| Graft-versus-host disease | |||
| cGVHD | Ibrutinib (as front line) | Phase II | NCT04294641 |
| Ibrutinib (with Rituximab) | Phase I/II | NCT03689894 | |
| Ibrutinib (with Rituximab) | Phase II | NCT04235036 | |
| Ibrutinib (with Corticosteroids) | Phase III | NCT02959944 | |
| steroid dependent/refractory | Ibrutinib | Phase III | NCT03474679 |
| Ibrutinib | Phase I/II - completed | NCT02195869 | |
| steroid refractory | Acalabrutinib | Phase II | NCT04198922 |
| pediatric subjects | Ibrutinib | Phase I/II | NCT03790332 |
| Autoimmune diseases | |||
| Autoimmune hemolytic anemia | |||
| refractory/relapsed | Ibrutinib | Phase II | NCT04398459 |
| steroid refractory, with underlying CLL | Ibrutinib (with Rituximab) | Phase II | NCT03827603 |
| Acalabrutinib | Phase II | NCT04657094 | |
| Rheumatoid arthritis | Acalabrutinib | Phase II - Completed | NCT02387762 |
| Allergic diseases | |||
| Anaphylaxis, food-induced | Ibrutinib | Phase II - completed | NCT03149315 |
| Infectious and inflammatory diseases | |||
| COVID-19 | Ibrutinib | Phase II | NCT04375397 |
| COVID-19 patients requiring hospitalization | Ibrutinib | Phase Ib/II | NCT04439006 |
| Acalabrutinib | Phase III | NCT04647669 | |
| Acalabrutinib | Phase II - completed | NCT04346199 | |
| Acalabrutinib | Phase II - completed | NCT04380688 | |
| Acalabrutinib | Phase I - completed | NCT04564040 | |
| COVID-19 in patients with B cell malignancies | Ibrutinib | Phase II | NCT04665115 |