26 completed, 15 active not recruiting, 3 terminated, 1 unknown. 24 Phase 1, 21 Phase 2, 7 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 24 | Completed 16, Active not recruiting 6, Terminated 2 |
| Phase 2 | 21 | Completed 12, Active not recruiting 6, Terminated 2, Unknown 1 |
| Phase 3 | 7 | Active not recruiting 6, Withdrawn 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) acalabrutinib, placebo, Prednisone - Diffuse Large B-Cell Lymphoma | Phase 3 | Active not recruiting | Acerta Pharma BV | 611 | 2020-10-08 | 2026-10-13 |
| Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19 Acalabrutinib - COVID-19 | Phase 1 | Terminated | Acerta Pharma BV | 9 | 2020-09-21 | 2021-11-17 |
| A Study to Evaluate Effects of Proton-pump Inhibitor on Acalabrutinib Capsule When Administered Orally With COCA-COLA in Healthy Participants Acalabrutinib, Rabeprazole - Infectious Disease | Phase 1 | Completed | AstraZeneca | 35 | 2020-07-20 | 2020-10-30 |
| Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19. Acalabrutinib - COVID-19 | Phase 2 | Completed | AstraZeneca | 62 | 2020-06-13 | 2021-09-13 |
| Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19. Acalabrutinib - COVID-19 | Phase 2 | Completed | AstraZeneca | 177 | 2020-06-12 | 2021-09-17 |
| A Study to Evaluate the Effect of Pharmacokinetics (PK) of Acalabrutinib and Its Active Metabolite (ACP-5862) When Administered Alone and With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole in Healthy Adult Participants Acalabrutinib, Fluconazole, Isavuconazole - Healthy Volunteers | Phase 1 | Completed | Acerta Pharma BV | 30 | 2020-01-03 | 2021-12-01 |
| Acalabrutinib Plus RICE for Relapsed/Refractory DLBCL Carboplatin, Ifosfamide, Etoposide - Diffuse Large B Cell Lymphoma | Phase 2 | Unknown | Swedish Medical Center | 47 | 2019-08-16 | 2022-07-22 |
| Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL Acalabrutinib, Venetoclax, Chemoimmunotherapy - Chronic Lymphocytic Leukemia | Phase 3 | Active not recruiting | Acerta Pharma BV | 984 | 2019-02-25 | 2026-10-05 |
| Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma Bendamustine, Rituximab, Acalabrutinib - Mantle Cell Lymphoma | Phase 2 | Completed | Washington University School of Medicine | 13 | 2018-11-29 | 2026-04-21 |
| Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite acalabrutinib - Hepatic Impairment, Hepatic Insufficiency | Phase 1 | Completed | Acerta Pharma BV | 16 | 2018-11-12 | 2021-09-10 |
| Platform Study for the Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma (PRISM Study) AZD9150, Acalabrutinib, AZD6738 - NHL, DLBCL | Phase 1 | Completed | Acerta Pharma BV | 30 | 2018-06-19 | 2022-08-15 |
| A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Ceralasertib, Acalabrutinib - Chronic Lymphocytic Leukemia | Phase 1 | Active not recruiting | Acerta Pharma BV | 12 | 2018-01-31 | 2026-07-14 |
| A Study of Acalabrutinib and Vistusertib in Subjects With Relapsed/Refractory B-cell Malignancies acalabrutinib, vistusertib - DLBCL, Richter Syndrome | Phase 1 / Phase 2 | Terminated | Acerta Pharma BV | 25 | 2017-06-29 | 2021-01-06 |
| A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL Acalabrutinib, Bendamustine, Rituximab - Lymphoma, Mantle Cell | Phase 3 | Active not recruiting | Acerta Pharma BV | 635 | 2017-04-05 | 2026-10-08 |
| A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL Acalabrutinib (ACP-196), Rituximab, Idelalisib - Chronic Lymphocytic Leukemia | Phase 3 | Active not recruiting | Acerta Pharma BV | 310 | 2017-02-02 | 2026-07-24 |
| A Study to Evaluate the Effect of Gastric pH on Acalabrutinib Pharmacokinetics (PK) in Healthy Adult Participants Acalabrutinib, SmartPill® - Healthy Volunteers | Phase 1 | Completed | Acerta Pharma BV | 12 | 2016-06-03 | 2021-06-03 |
| A Study of Acalabrutinib in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma acalabrutinib, ibrutinib, rituximab - Mantle Cell Lymphoma | Phase 3 | Withdrawn | Acerta Pharma BV | 2016-05-01 | 2016-05-13 | |
| A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL Acalabrutinib in combination with BR, Acalabrutinib in combination with VR - Mantle Cell Lymphoma (MCL) | Phase 1 | Active not recruiting | Acerta Pharma BV | 72 | 2016-04-20 | 2026-07-14 |
| A Study to Evaluate the Effect of ACP-196 on the Heart Rate-corrected QT Interval in Healthy Adult Participants ACP-196, Moxifloxacin 400 mg, Placebo - Healthy Volunteers | Phase 1 | Completed | Acerta Pharma BV | 48 | 2016-04-01 | 2021-04-30 |
| A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy ACP-196 (acalabrutinib) - Chronic Lymphocytic Leukemia | Phase 2 | Active not recruiting | Acerta Pharma BV | 60 | 2016-03-08 | 2026-03-25 |
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Leukemia, Lymphocytic, Chronic, B-Cell (12) · Lymphoma, Mantle-Cell (6) · Lymphoma, Non-Hodgkin (5) · Lymphoma, Large B-Cell, Diffuse (4) · COVID-19 (3) · Lymphoma (3) · Multiple Myeloma (3) · Hepatic Insufficiency (2) · Leukemia (2) · Leukemia, Prolymphocytic (2) · Lymphoma, Follicular (2) · Pancreatic Neoplasms (2) · Waldenstrom Macroglobulinemia (2) · Arthritis, Rheumatoid (1) · Burkitt Lymphoma (1)
acalabrutinib (46) · Rituximab (9) · pembrolizumab (5) · Bendamustine Hydrochloride (3) · obinutuzumab (3) · Cytarabine (2) · N-(1-(7-fluoro-2-(pyridin-2-yl)quinolin-3-yl)ethyl)-9H-purin-6-amine (2) · Omeprazole (2) · ceralasertib (2) · ibrutinib (2) · venetoclax (2) · 130-nm albumin-bound paclitaxel (1) · AZD5153 (1) · Albumin-Bound Paclitaxel (1) · Calcium Carbonate (1)
United States (42) · United Kingdom (13) · Italy (12) · France (10) · Poland (10) · Spain (9) · Australia (7) · Belgium (7) · Germany (7) · Israel (7) · Brazil (6) · Canada (6) · Czechia (5) · Hungary (5) · Russia (5)
Priti Patel, MD (3) · Ahmed Hamdy, MD (1) · Arnon Kater (1) · Barbara Eichhorst (1) · Brad S Kahl, M.D. (1) · Ian Flinn, MD, PhD (1) · Jennifer Brown (1)
PMID 39563886, PMID 40461100, PMID 26641137, PMID 27601462, PMID 28714866, PMID 29241979, PMID 31088809, PMID 31866281, PMID 31876911, PMID 31915195, PMID 32054731, PMID 32114502, PMID 32202637, PMID 32305093, PMID 32459600, PMID 33709202, PMID 33730844, PMID 33796237, PMID 34269152, PMID 34310172, PMID 34398557, PMID 34534514, PMID 34608724, PMID 34735860, PMID 36442911, PMID 37227160, PMID 37273420, PMID 37390310, PMID 38598745, PMID 38754046, PMID 38781315, PMID 39716442, PMID 39976417, PMID 40198878, PMID 40311141, PMID 40485230, PMID 41044668, PMID 41915892, PMID 41985004
2023 (9), 2014 (6), 2015 (3), 2019 (2), 2016 (1), 2017 (1), 2018 (1)