Numerous clinical trials evaluate acalabrutinib (ACP-196) across Early Phase 1 through Phase 4, primarily focusing on B-cell malignancies—such as mantle cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, and diffuse large B-cell lymphoma—as well as non-small-cell lung carcinoma and healthy volunteers. Sponsored by both major pharmaceutical companies and academic research groups, these studies span recruiting, active not recruiting, and completed recruitment statuses worldwide.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06846489 | RECRUITING | Mantle Cell Lymphoma (MCL) |
Sun Yat-sen University |
2025-04-14 | PHASE2 |
| NCT06136559 | RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Merck Sharp & Dohme LLC |
2023-12-13 | PHASE3 |
| NCT07377578 | RECRUITING | Mantle Cell Lymphoma |
Guangzhou Lupeng Pharmaceutical Company LTD. |
2026-02-05 | PHASE3 |
| NCT07277231 | RECRUITING | Chronic Lymphocytic Leukemia |
BeOne Medicines |
2026-01-22 | PHASE3 |
| NCT06651970 | RECRUITING | Chronic Lymphocytic Leukaemia; Moderate to Severe Cardiac Impairment |
AstraZeneca |
2025-02-04 | PHASE4 |
| NCT06520098 | RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
VA Office of Research and Development |
2025-10-01 | PHASE2 |
| NCT03868722 | RECRUITING | CLL |
Rigshospitalet, Denmark |
2019-10-11 | PHASE2; PHASE3 |
| NCT06564038 | RECRUITING | Chronic Lymphocytic Leukaemia; Small Lymphocytic Lymphoma; Mantle-cell Lymphoma; Large B-cell Lymphoma; B-cell Non-Hodgkin Lymphoma |
AstraZeneca |
2025-01-30 | PHASE1; PHASE2 |
| NCT07024706 | RECRUITING | Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL) |
AstraZeneca |
2026-06-04 | PHASE2 |
| NCT05952024 | RECRUITING | Diffuse Large B-Cell Lymphoma |
AstraZeneca |
2024-07-16 | PHASE2 |
| NCT07582159 | NOT_YET_RECRUITING | Chronic Lymphocytic Leukemia; Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Small Lymphocytic Lymphoma |
City of Hope Medical Center |
2026-12-19 | PHASE2 |
| NCT05820841 | RECRUITING | Large B-cell Lymphoma; Diffuse Large B Cell Lymphoma |
Universität des Saarlandes |
2023-06-07 | PHASE3 |
| NCT07635511 | NOT_YET_RECRUITING | Hematological Malignancies; Platelet Transfusion Refractoriness (PTR); HLA Antibodies |
The First Affiliated Hospital of Soochow University |
2026-06-01 | PHASE3 |
| NCT07052695 | RECRUITING | Leukemia; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Lymphoma |
Inhye Ahn |
2025-11-24 | PHASE1; PHASE2 |
| NCT04523428 | RECRUITING | CLL/SLL |
Stichting Hemato-Oncologie voor Volwassenen Nederland |
2020-12-23 | PHASE2 |
| NCT07257055 | RECRUITING | Phase 2 Study; MCL; BTKi; Rituximab; Glofitamab |
M.D. Anderson Cancer Center |
2026-04-01 | PHASE2 |
| NCT05951959 | ACTIVE_NOT_RECRUITING | Mantle Cell Lymphoma (MCL) |
AstraZeneca |
2023-12-13 | PHASE2 |
| NCT04566887 | ACTIVE_NOT_RECRUITING | Mantle Cell Lymphoma |
University Health Network, Toronto |
2021-03-01 | PHASE2 |
| NCT04765111 | ACTIVE_NOT_RECRUITING | Mantle Cell Lymphoma |
M.D. Anderson Cancer Center |
2021-06-30 | PHASE2 |
| NCT06839872 | WITHDRAWN | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
AstraZeneca |
2025-06-30 | PHASE2 |
| NCT04169737 | RECRUITING | Recurrent Chronic Lymphocytic Leukemia; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Small Lymphocytic Lymphoma |
M.D. Anderson Cancer Center |
2020-07-29 | PHASE2 |
| NCT03899337 | ACTIVE_NOT_RECRUITING | Richter Syndrome |
University of Birmingham |
2019-07-23 | PHASE2 |
| NCT07014917 | RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; CLL Variant |
Zulfa Omer |
2025-12-05 | PHASE2 |
| NCT05197192 | RECRUITING | Chronic Lymphocytic Leukemia |
German CLL Study Group |
2022-04-19 | PHASE3 |
| NCT04560322 | RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Massachusetts General Hospital |
2020-10-19 | PHASE2 |
| NCT04404088 | ACTIVE_NOT_RECRUITING | Ann Arbor Stage III Grade 1 Follicular Lymphoma; Ann Arbor Stage III Grade 2 Follicular Lymphoma; Ann Arbor Stage III Grade 3 Follicular Lymphoma; Ann Arbor Stage IV Grade 1 Follicular Lymphoma; Ann Arbor Stage IV Grade 2 Follicular Lymphoma; Ann Arbor Stage IV Grade 3 Follicular Lymphoma; Grade 3a Follicular Lymphoma |
M.D. Anderson Cancer Center |
2020-07-16 | PHASE2 |
| NCT06428019 | RECRUITING | Chronic Lymphocytic Leukemia |
AbbVie |
2024-08-05 | PHASE3 |
| NCT03946878 | ACTIVE_NOT_RECRUITING | Blastoid Variant Mantle Cell Lymphoma; CCND1 Protein Overexpression; CD20 Positive; CD5 Positive; FCER2 Negative; Pleomorphic Variant Mantle Cell Lymphoma; Recurrent Mantle Cell Lymphoma; Refractory Mantle Cell Lymphoma; t(11;14)(q13;q32) |
M.D. Anderson Cancer Center |
2019-08-13 | PHASE2 |
| NCT06441097 | NOT_YET_RECRUITING | Diffuse Large B-Cell Lymphoma |
Ruijin Hospital |
2024-12-31 | PHASE2 |
| NCT07029737 | RECRUITING | Mantle-cell Lymphoma |
AstraZeneca |
2025-09-05 | PHASE2 |
| NCT06958705 | RECRUITING | Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) |
The First Affiliated Hospital with Nanjing Medical University |
2025-12-01 | PHASE2 |
| NCT04546620 | ACTIVE_NOT_RECRUITING | Diffuse Large B Cell Lymphoma |
University Hospital Southampton NHS Foundation Trust |
2021-10-19 | PHASE2 |
| NCT04646395 | ACTIVE_NOT_RECRUITING | Marginal Zone Lymphoma |
International Extranodal Lymphoma Study Group (IELSG) |
2021-10-20 | PHASE2 |
| NCT04941716 | RECRUITING | Recurrent Chronic Lymphocytic Leukemia; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Small Lymphocytic Lymphoma |
Fred Hutchinson Cancer Center |
2023-05-31 | PHASE2 |
| NCT06319456 | RECRUITING | CLL/SLL |
Ascentage Pharma Group Inc. |
2024-04-07 | PHASE3 |
| NCT05057494 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
AstraZeneca |
2022-09-12 | PHASE3 |
| NCT04189757 | ACTIVE_NOT_RECRUITING | Mantle Cell Lymphoma |
M.D. Anderson Cancer Center |
2020-08-07 | PHASE2 |
| NCT04855695 | RECRUITING | Mantle Cell Lymphoma; Refractory Lymphoma |
Austin I Kim |
2021-07-02 | PHASE1; PHASE2 |
| NCT04505254 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
M.D. Anderson Cancer Center |
2020-08-25 | PHASE2 |
| NCT04002947 | RECRUITING | Non-Hodgkin's Lymphoma; Diffuse Large B-Cell Lymphoma; DLBCL; NHL |
National Cancer Institute (NCI) |
2019-08-05 | PHASE2 |
| NCT03128879 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia |
M.D. Anderson Cancer Center |
2017-06-16 | PHASE2 |
| NCT05495464 | ACTIVE_NOT_RECRUITING | Lymphoma; Mantle Cell Lymphoma |
M.D. Anderson Cancer Center |
2022-11-18 | EARLY_PHASE1 |
| NCT03516617 | RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Mayo Clinic |
2018-09-10 | PHASE2 |
| NCT05388006 | RECRUITING | Chronic Lymphocytic Leukemia; Richter Syndrome; Small Lymphocytic Lymphoma |
Mayo Clinic |
2023-01-05 | PHASE2 |
| NCT04529772 | ACTIVE_NOT_RECRUITING | Diffuse Large B-Cell Lymphoma |
Acerta Pharma BV |
2020-10-08 | PHASE3 |
| NCT02972840 | ACTIVE_NOT_RECRUITING | Lymphoma, Mantle Cell |
Acerta Pharma BV |
2017-04-05 | PHASE3 |
| NCT04722172 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Memorial Sloan Kettering Cancer Center |
2021-05-21 | PHASE2 |
| NCT05256641 | RECRUITING | Diffuse Large B-Cell Lymphoma; High-grade B-cell Lymphoma; Transformed Lymphoma; Secondary Central Nervous System Lymphoma |
Jonsson Comprehensive Cancer Center |
2023-01-23 | PHASE1; PHASE2 |
| NCT03836261 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia |
Acerta Pharma BV |
2019-02-25 | PHASE3 |
| NCT04978584 | ACTIVE_NOT_RECRUITING | Diffuse Large B-Cell Lymphoma |
M.D. Anderson Cancer Center |
2022-03-03 | PHASE2 |
| NCT05943496 | RECRUITING | Chronic Lymphocytic Leukemia |
OHSU Knight Cancer Institute |
2023-10-02 | PHASE1 |
| NCT05214183 | ACTIVE_NOT_RECRUITING | MCL; Mantle Cell Lymphoma |
Nordic Lymphoma Group |
2021-12-15 | PHASE2 |
| NCT04662255 | ACTIVE_NOT_RECRUITING | Lymphoma, Mantle-Cell |
Loxo Oncology, Inc. |
2021-04-08 | PHASE3 |
| NCT05971251 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia |
University of Alabama at Birmingham |
2023-12-18 | PHASE1 |
| NCT06757647 | RECRUITING | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
Seema Bhat |
2025-05-27 | PHASE2 |
| NCT04115631 | ACTIVE_NOT_RECRUITING | Liver Lymphoma; Mantle Cell Lymphoma |
ECOG-ACRIN Cancer Research Group |
2019-12-13 | PHASE2 |
| NCT05065554 | ACTIVE_NOT_RECRUITING | IgM MGUS; Waldenstrom Macroglobulinemia; Neuropathy;Peripheral |
Shayna Sarosiek, MD |
2021-11-16 | PHASE2 |
| NCT05336812 | RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Ohio State University Comprehensive Cancer Center |
2022-09-13 | PHASE2 |
| NCT06054776 | RECRUITING | Mantle Cell Lymphoma |
City of Hope Medical Center |
2024-12-02 | PHASE2 |
| NCT03571568 | RECRUITING | Indolent B-Cell Non-Hodgkin Lymphoma |
BioInvent International AB |
2018-05-16 | PHASE1; PHASE2 |
| NCT04883437 | RECRUITING | Grade 1 Follicular Lymphoma; Grade 2 Follicular Lymphoma; Grade 3a Follicular Lymphoma; Indolent Non-Hodgkin Lymphoma; Lymphoplasmacytic Lymphoma; Lymphoproliferative Disorder; Mantle Cell Lymphoma; Marginal Zone Lymphoma |
Emory University |
2021-09-03 | PHASE2 |
| NCT04484012 | RECRUITING | Recurrent Mantle Cell Lymphoma; Refractory Mantle Cell Lymphoma |
City of Hope Medical Center |
2020-12-31 | PHASE2 |
| NCT04462328 | ACTIVE_NOT_RECRUITING | Primary Central Nervous System Lymphoma |
Washington University School of Medicine |
2021-04-29 | PHASE1 |
| NCT04604067 | ACTIVE_NOT_RECRUITING | Diffuse Large B-cell Lymphoma |
Swiss Cancer Institute |
2021-06-25 | PHASE2 |
| NCT05004064 | ACTIVE_NOT_RECRUITING | Mantle Cell Lymphoma |
University College, London |
2023-11-30 | PHASE2 |
| NCT05950997 | RECRUITING | Chronic Lymphocytic Leukemia |
The First Affiliated Hospital with Nanjing Medical University |
2024-04-16 | |
| NCT04116437 | COMPLETED | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Mantle Cell Lymphoma; Marginal Zone Lymphoma; Waldenstrom Macroglobulinemia |
BeiGene |
2019-10-15 | PHASE2 |
| NCT04660045 | WITHDRAWN | Chronic Lymphocytic Leukemia; CLL/SLL |
Weill Medical College of Cornell University |
2022-05 | PHASE2 |
| NCT04961801 | WITHDRAWN | Lymphoma; Leukemia |
Shin Mineishi |
2022-03 | PHASE1; PHASE2 |
| NCT04688151 | ACTIVE_NOT_RECRUITING | Primary Central Nervous System Lymphoma (PCNSL) |
National Health Research Institutes, Taiwan |
2021-02-22 | PHASE1 |
| NCT04624906 | ACTIVE_NOT_RECRUITING | Waldenstrom Macroglobulinemia |
Sunnybrook Health Sciences Centre |
2021-03-02 | PHASE2 |
| NCT04906902 | ACTIVE_NOT_RECRUITING | Central Nervous System Lymphoma; Refractory Central Nervous System Lymphoma; Recurrent Central Nervous System Lymphoma |
Dana-Farber Cancer Institute |
2021-08-23 | PHASE1; PHASE2 |
| NCT04008706 | COMPLETED | Chronic Lymphocytic Leukemia |
AstraZeneca |
2019-09-17 | PHASE3 |
| NCT04198922 | ACTIVE_NOT_RECRUITING | Recurrent Moderate-Severe Chronic Graft Versus Host Disease; Hematopoietic and Lymphoid Cell Neoplasm |
Fred Hutchinson Cancer Center |
2020-12-11 | PHASE2 |
| NCT04257578 | ACTIVE_NOT_RECRUITING | B-Cell Non-Hodgkin Lymphoma; Diffuse Large B-Cell Lymphoma, Not Otherwise Specified; High Grade B-Cell Lymphoma; Primary Mediastinal (Thymic) Large B-Cell Lymphoma; Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma; Grade 1 Follicular Lymphoma; Grade 2 Follicular Lymphoma; Grade 3a Follicular Lymphoma |
University of Washington |
2020-12-02 | PHASE1; PHASE2 |
| NCT04626791 | ACTIVE_NOT_RECRUITING | Mantle Cell Lymphoma |
Academic and Community Cancer Research United |
2021-08-03 | PHASE2 |
| NCT04963946 | ACTIVE_NOT_RECRUITING | Untreated Chronic Lymphocytic Leukemia |
French Innovative Leukemia Organisation |
2021-10-18 | PHASE2 |
| NCT04548648 | ACTIVE_NOT_RECRUITING | Central Nervous System Lymphoma |
UNC Lineberger Comprehensive Cancer Center |
2020-10-15 | PHASE2 |
| NCT04883749 | COMPLETED | Chronic Lymphoid Leukemia |
German CLL Study Group |
2021-06-01 | PHASE2 |
| NCT04178798 | COMPLETED | Chronic Lymphocytic Leukemia- Binet Staging System |
PETHEMA Foundation |
2019-12-09 | PHASE3 |
| NCT05583149 | ACTIVE_NOT_RECRUITING | Refractory Aggressive B-cell Lymphomas; Refractory B-Cell Non-Hodgkin Lymphoma; Aggressive B-cell NHL; Diffuse Large B-cell Lymphoma (DLBCL); De Novo or Transformed Indolent B-cell Lymphoma; DLBCL, Nos Genetic Subtypes; T Cell/Histiocyte-rich Large B-cell Lymphoma; EBV-Positive DLBCL, Nos; Primary Mediastinal [Thymic] Large B-cell Lymphoma (PMBCL); High-Grade B-Cell Lymphoma, Nos; C-MYC/BCL6 Double-Hit High-Grade B-Cell Lymphoma; Grade 3b Follicular Lymphoma; C-MYC/BCL2 Double-Hit High-Grade B-Cell Lymphoma |
Patrick C. Johnson, MD |
2023-03-01 | PHASE2 |
| NCT04716075 | COMPLETED | Chronic Lymphocytic Leukemia; Chronic Graft-versus-host-disease; Mantle Cell Lymphoma; Adverse Event; Response Rate |
Polish Lymphoma Research Group |
2019-08-19 | PHASE2 |
| NCT03863184 | ACTIVE_NOT_RECRUITING | Mantle Cell Lymphoma |
Weill Medical College of Cornell University |
2019-10-11 | PHASE2 |
| NCT03580928 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia (CLL) |
Dana-Farber Cancer Institute |
2018-08-07 | PHASE2 |
| NCT04402138 | COMPLETED | Mantle Cell Lymphoma |
SCRI Development Innovations, LLC |
2020-08-07 | PHASE2 |
| NCT04075292 | ACTIVE_NOT_RECRUITING | Untreated Chronic Lymphocytic Leukemia |
AstraZeneca |
2020-01-20 | PHASE3 |
| NCT04836832 | WITHDRAWN | Recurrent Follicular Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Nodal Marginal Zone Lymphoma; Recurrent Splenic Marginal Zone Lymphoma; Refractory Follicular Lymphoma; Refractory Indolent Non-Hodgkin Lymphoma; Refractory Marginal Zone Lymphoma; Refractory Nodal Marginal Zone Lymphoma; Refractory Splenic Marginal Zone Lymphoma |
Narendranath Epperla |
2022-07-01 | PHASE1 |
| NCT04624633 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Relapsed Chronic Lymphocytic Leukemia; Refractory Chronic Lymphocytic Leukemia |
Jennifer R. Brown, MD, PhD |
2020-12-15 | PHASE2 |
| NCT05951959 | Recruiting | Mantle Cell Lymphoma (MCL) |
AstraZeneca |
2023-12-13 | Phase 2 |
| NCT06170671 | Recruiting | Chronic Lymphocytic Leukemia |
AstraZeneca |
2023-12-13 | -- |
| NCT03492125 | TERMINATED | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Aggressive Lymphoma |
MingSight Pharmaceuticals, Inc |
2018-05-25 | PHASE1; PHASE2 |
| NCT04630756 | COMPLETED | Advanced Haematological Malignancies |
AstraZeneca |
2021-02-17 | PHASE1; PHASE2 |
| NCT03736616 | UNKNOWN | Diffuse Large B Cell Lymphoma |
Swedish Medical Center |
2019-08-16 | PHASE2 |
| NCT02180711 | ACTIVE_NOT_RECRUITING | Non Hodgkin Lymphoma |
Acerta Pharma BV |
2014-12-29 | PHASE1; PHASE2 |
| NCT06205498 | Recruiting | Chronic Lymphocytic Leukemia |
AstraZeneca|Yghea |
2023-08-08 | -- |
| NCT05205252 | WITHDRAWN | Relapsed Hematologic Malignancy; Refractory Hematologic Malignancy |
Epizyme, Inc. |
2021-12-22 | PHASE1; PHASE2 |
| NCT05999877 | Active not recruiting | Chronic Lymphocytic Leukemia |
AstraZeneca |
2023-07-11 | -- |
| NCT05820841 | Recruiting | Large B-cell Lymphoma|Diffuse Large B Cell Lymphoma |
Universität des Saarlandes|University of Leipzig|University Hospital Regensburg|Wuerzburg University Hospital|University Hospital of Gießen and Marburg|Saarland University Medical Center|AstraZeneca |
2023-06-07 | Phase 3 |
| NCT03788291 | COMPLETED | Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL) |
University of Rochester |
2019-03-25 | PHASE2 |
| NCT04930536 | COMPLETED | Chronic Lymphocytic Leukemia and Relapsed and Refractory Mantle Cell Lymphoma |
AstraZeneca |
2021-07-14 | PHASE4 |
| NCT04657094 | ACTIVE_NOT_RECRUITING | Autoimmune Hemolytic Anemia; Chronic Lymphocytic Leukemia; Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Warm Antibody Autoimmune Hemolytic Anemia |
City of Hope Medical Center |
2021-03-16 | PHASE2 |
| NCT04685915 | WITHDRAWN | Chronic Lymphocytic Leukemia (CLL) |
Inhye Ahn |
2021-02-18 | PHASE2 |
| NCT03932331 | ACTIVE_NOT_RECRUITING | Phase I: Relapsed or Refractory B-cell Malignancies; Phase II Cohort A: Relapsed or Refractory Mantle Cell Lymphoma; Phase II Cohort B: Relapsed or Refractory Chronic Lymphocytic Leukemia |
AstraZeneca |
2020-04-29 | PHASE1; PHASE2 |
| NCT05038904 | COMPLETED | Food Allergy; Food Allergy Peanut |
Johns Hopkins University |
2021-12-16 | PHASE2 |
| NCT03198650 | COMPLETED | Part1: Advanced B-cell Malignancies; Part2: r/rCLL and r/rMCL; Part3: Untreated CLL |
AstraZeneca |
2017-06-27 | PHASE1 |
| NCT04502394 | RECRUITING | Diffuse Large B Cell Lymphoma; Chronic Lymphocytic Leukemia; Non Hodgkin Lymphoma |
Kartos Therapeutics, Inc. |
2021-02-23 | PHASE1; PHASE2 |
| NCT04783415 | ACTIVE_NOT_RECRUITING | Mantle Cell Lymphoma |
City of Hope Medical Center |
2021-03-26 | PHASE2 |
| NCT04337827 | TERMINATED | Post-transplant Lymphoproliferative Disorder |
Deepa Jagadeesh |
2020-09-02 | PHASE2 |
| NCT02717624 | ACTIVE_NOT_RECRUITING | Mantle Cell Lymphoma (MCL) |
Acerta Pharma BV |
2016-04-20 | PHASE1 |
| NCT04016805 | TERMINATED | Chronic Lymphocytic Leukemia |
TG Therapeutics, Inc. |
2019-08-05 | PHASE2 |
| NCT04094142 | COMPLETED | Non-hodgkin Lymphoma,B Cell |
Seoul National University Hospital |
2019-07-09 | PHASE2 |
| NCT04647669 | UNKNOWN | Covid19 |
The University of The West Indies |
2021-06-01 | PHASE3 |
| NCT03328273 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia |
Acerta Pharma BV |
2018-01-31 | PHASE1 |
| NCT02970318 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia |
Acerta Pharma BV |
2017-02-02 | PHASE3 |
| NCT04419389 | TERMINATED | Non Hodgkin Lymphoma; Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma |
Aprea Therapeutics |
2021-03-02 | PHASE1; PHASE2 |
| NCT02296918 | COMPLETED | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Prolymphocytic Leukemia |
Acerta Pharma BV |
2014-12-22 | PHASE1 |
| NCT02029443 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Richter's Syndrome; Prolymphocytic Leukemia |
Acerta Pharma BV |
2014-01-30 | PHASE1; PHASE2 |
| NCT04189952 | TERMINATED | Diffuse Large B Cell Lymphoma; Chronic Lymphocytic Leukemia; Small Lymphocytic Leukemia; Marginal Zone Lymphoma |
University of Miami |
2020-09-22 | PHASE2 |
| NCT04768985 | COMPLETED | Bioequivalence |
AstraZeneca |
2021-02-25 | PHASE1 |
| NCT05024006 | COMPLETED | Covid19 |
University of the Philippines |
2020-04-23 | |
| NCT03527147 | COMPLETED | NHL; DLBCL; Non-hodgkin's Lymphoma; Diffuse Large B Cell Lymphoma |
Acerta Pharma BV |
2018-06-19 | PHASE1 |
| NCT03787264 | COMPLETED | Chronic Lymphoid Leukemia |
German CLL Study Group |
2019-01-14 | PHASE2 |
| NCT04488016 | COMPLETED | Bioavailability; B-cell Lymphoid Cancer |
AstraZeneca |
2020-06-24 | PHASE1 |
| NCT04564040 | COMPLETED | Mantle Cell Lymphoma; COVID-19 |
AstraZeneca |
2020-10-12 | PHASE1 |
| NCT02213926 | ACTIVE_NOT_RECRUITING | Mantle Cell Lymphoma (MCL) |
Acerta Pharma BV |
2015-03-02 | PHASE2 |
| NCT04497948 | TERMINATED | COVID-19 |
Acerta Pharma BV |
2020-09-21 | PHASE1 |
| NCT04346199 | COMPLETED | COVID-19 |
AstraZeneca |
2020-06-12 | PHASE2 |
| NCT04380688 | COMPLETED | COVID-19 |
AstraZeneca |
2020-06-13 | PHASE2 |
| NCT02717611 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia |
Acerta Pharma BV |
2016-03-08 | PHASE2 |
| NCT02477696 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia |
Acerta Pharma BV |
2015-07-28 | PHASE3 |
| NCT04489797 | COMPLETED | Infectious Disease |
AstraZeneca |
2020-07-20 | PHASE1 |
| NCT02157324 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia |
Acerta Pharma BV |
2014-08-18 | PHASE1 |
| NCT02362035 | COMPLETED | Follicular Lymphoma (FL); CLL; Small Lymphocytic Lymphoma (SLL); Richter's Syndrome; Mantle Cell Lymphoma (MCL); Indolent Non Hodgkin Lymphoma; Waldenström Macroglobulinemia; Multiple Myeloma; Hodgkin Lymphoma; Burkitt Lymphoma; Marginal Zone Lymphomas; Mediastinal Large B Cell Lymphoma; Hairy Cell Leukemia |
Acerta Pharma BV |
2015-02-20 | PHASE1; PHASE2 |
| NCT02112526 | COMPLETED | Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL) |
Acerta Pharma BV |
2014-08-07 | PHASE1 |
| NCT02337829 | COMPLETED | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Acerta Pharma BV |
2015-01-12 | PHASE2 |
| NCT04435483 | COMPLETED | Pharmacokinetics; Bioavailability |
AstraZeneca |
2020-05-22 | PHASE1 |
| NCT02586857 | ACTIVE_NOT_RECRUITING | Glioblastoma Multiforme |
Acerta Pharma BV |
2016-01-25 | PHASE1; PHASE2 |
| NCT02328014 | COMPLETED | Non-Hodgkins Lymphoma; Multiple Myeloma; B-All |
Acerta Pharma BV |
2014-12-20 | PHASE1; PHASE2 |
| NCT02735876 | WITHDRAWN | Mantle Cell Lymphoma |
Acerta Pharma BV |
2016-05 | PHASE3 |
| NCT05140096 | COMPLETED | Healthy Volunteers |
Acerta Pharma BV |
2020-01-03 | PHASE1 |
| NCT03623373 | COMPLETED | Mantle Cell Lymphoma |
Washington University School of Medicine |
2018-11-29 | PHASE2 |
| NCT03571308 | COMPLETED | Non Hodgkin Lymphoma |
University Hospital Southampton NHS Foundation Trust |
2017-06-02 | PHASE1; PHASE2 |
| NCT03205046 | TERMINATED | DLBCL; Richter Syndrome |
Acerta Pharma BV |
2017-06-29 | PHASE1; PHASE2 |
| NCT02180724 | ACTIVE_NOT_RECRUITING | Waldenström Macroglobulinemia (WM) |
Acerta Pharma BV |
2014-09-11 | PHASE2 |
| NCT02211014 | COMPLETED | Multiple Myeloma (MM) |
Acerta Pharma BV |
2015-02 | PHASE1 |
| NCT03968848 | COMPLETED | Hepatic Impairment; Hepatic Insufficiency; Healthy Subjects |
Acerta Pharma BV |
2018-11-12 | PHASE1 |
| NCT02475681 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia |
Acerta Pharma BV |
2015-06-26 | PHASE3 |
| NCT02537444 | COMPLETED | Ovarian Cancer |
Acerta Pharma BV |
2015-11 | PHASE2 |
| NCT02454179 | COMPLETED | Squamous Cell Carcinoma of the Head and Neck |
Acerta Pharma BV |
2015-05 | PHASE2 |
| NCT02448303 | COMPLETED | Carcinoma, Non-Small-Cell Lung |
Acerta Pharma BV |
2015-05 | PHASE2 |
| NCT02351739 | COMPLETED | Metastatic Urothelial Carcinoma |
Acerta Pharma BV |
2015-04 | PHASE2 |
| NCT02362048 | COMPLETED | Metastatic Pancreatic Cancer |
Acerta Pharma BV |
2015-05 | PHASE2 |
| NCT04905043 | COMPLETED | Healthy Volunteers |
Acerta Pharma BV |
2016-06-03 | PHASE1 |
| NCT04867980 | COMPLETED | Healthy Volunteers |
Acerta Pharma BV |
2016-04-01 | PHASE1 |
| NCT02387762 | COMPLETED | Rheumatoid Arthritis |
Acerta Pharma BV |
2015-04 | PHASE2 |
| NCT04898101 | COMPLETED | Healthy Volunteers |
Acerta Pharma BV |
2016-03-03 | PHASE1 |
| NCT02570711 | TERMINATED | Metastatic Pancreatic Cancer |
Acerta Pharma BV |
2015-10-13 | PHASE2 |
| NCT04876807 | COMPLETED | Healthy Volunteers |
Acerta Pharma BV |
2016-01-28 | PHASE1 |
| NCT04867941 | COMPLETED | Hepatic Insufficiency |
Acerta Pharma BV |
2014-10-21 | PHASE1 |
| NCT04914936 | COMPLETED | Healthy Participants |
Acerta Pharma BV |
2014-09-21 | PHASE1 |
| NCT04901923 | COMPLETED | Healthy Participants |
Acerta Pharma BV |
2014-03-15 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2025-06-03)
Check the
Acalabrutinib (ACP-196)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Acalabrutinib (ACP-196) Solubility in DMSO
- Acalabrutinib (ACP-196) Stock Solution
- Acalabrutinib (ACP-196) Storage
- Acalabrutinib (ACP-196) Stability
- Acalabrutinib (ACP-196) Molecular Weight
- Acalabrutinib (ACP-196) SMILES
- Acalabrutinib (ACP-196) CAS Number
- Acalabrutinib (ACP-196) Chemical Structure (2D and 3D)
- Acalabrutinib (ACP-196) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.