Calquence (acalabrutinib) / AstraZeneca  >>  Phase 3
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25 Trials

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Calquence (acalabrutinib) / AstraZeneca
ELEVATE-TN, NCT02475681 / 2014-005582-73: Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL

Hourglass Dec 2023 - Dec 2023 : Data from ELEVATE-TN in treatment-naive chronic lymphocytic leukemia at ASH 2023
Checkmark 5-year PFS data from ELEVATE CLL TN trial for CLL at ASCO 2022
Jun 2022 - Jun 2022: 5-year PFS data from ELEVATE CLL TN trial for CLL at ASCO 2022
Checkmark Presentation of data from ELEVATE TN trial in combination with obinutuzumab for 1L CLL at ASCO 2022
Jun 2022 - Jun 2022: Presentation of data from ELEVATE TN trial in combination with obinutuzumab for 1L CLL at ASCO 2022
More
Active, not recruiting
3
535
Europe, Canada, US, RoW
Acalabrutinib, ACP-196 (Calquence), Obinutuzumab, GAZYVA / GAZYVARO, Chlorambucil, LEUKERAN
Acerta Pharma BV
Chronic Lymphocytic Leukemia
02/19
09/25
2018-002443-28: This study is being done to test the effectiveness and safety of an investigational drug called acalabrutinib (ACP-196) when taken with already marketed drugs called Venetoclax and Obinutzumab in comparison to chemotherapy that is already in wide use for treatment of patients who have chronic lymphocytic leukemia and who have never been treated before.

Not yet recruiting
3
780
Europe, RoW
acalabrutinib, ACP-196, Capsule, hard, Concentrate for solution for infusion, Powder for solution for injection/infusion, Concentrate for solution for injection/infusion, Film-coated tablet, Powder for concentrate for solution for infusion, Gazyvaro, MABTHERA, Venclyxto
Acerta Pharma B.V., ACERTA PHARMA BV, AstraZeneca, Acerta Pharma B.V., AstraZeneca AB, ASTRAZENECA AB, Acerta BV
Previously untreated Chronic Lymphocytic Leukemia Without del(17p) or TP53 Mutation, Previously untreated low-risk blood cancer, Diseases [C] - Cancer [C04]
 
 
2019-001804-39: Study to Investigate the Use of Acalabrutinib in the Treatment of Patients With Chronic Lymphocytic Leukemia Estudio para investigar el uso de acalabrutinib en el tratamiento de pacientes con Leucemia Linfocítica Crónica

Not yet recruiting
3
130
Europe
Acalabrutinib, ACP-196, Capsule, hard
Fundación PETHEMA, AstraZeneca
Early Stage CLL With High Risk of Early Disease Progression LLC en estadio temprano con alto riesgo de progresión temprana de la enfermedad, Chronic lymphocytic leukemia Leucemia Linfocítica Crónica, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
NCT02735876: A Study of Acalabrutinib in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Withdrawn
3
0
US
acalabrutinib, ibrutinib, rituximab
Acerta Pharma BV
Mantle Cell Lymphoma
06/20
 
ELEVATE-RR, NCT02477696 / 2014-005530-64: Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)

Checkmark Presentation of data from ELEVATE-RR trial in r/r CLL at ASH 2022
Nov 2022 - Nov 2022: Presentation of data from ELEVATE-RR trial in r/r CLL at ASH 2022
Checkmark From ELEVATE-RR trial in r/r CLL at ASH 2021
Dec 2021 - Dec 2021: From ELEVATE-RR trial in r/r CLL at ASH 2021
Checkmark From ELEVATE-RR trial in combination with Ibrutinib for previously Treated Patients With CLL
More
Active, not recruiting
3
533
Europe, US, RoW
Acalabrutinib, ACP-196, Ibrutinib
Acerta Pharma BV
Chronic Lymphocytic Leukemia
09/20
01/28
2019-001755-39: A Study of Acalabrutinib in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤65 Years with Previously Untreated Non-Germinal Center Diffuse Large B-Cell Lymphoma.

Ongoing
3
600
Europe
acalabrutinib, rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, ACP-196, L01X C02, Capsule, hard, Concentrate for solution for infusion, Powder for solution for injection, Solution for infusion, Solution for injection, Tablet, MabThera 500 mg concentrate for solution for infusion, Endoxan 500 mg Powder for solution for injection, Ribodoxo 2 mg/ml solution for infusion, Vincristinesulfat-TEVA 1 mg/ml Injectable solution, Prednisone HEXAL 20 mg tablets
Acerta Pharma B.V. (A Member of the AstraZeneca Group), ACERTA PHARMA BV, AstraZeneca
Diffuse large B-cell lymphoma, A type of non-Hodgkin lymphoma that develops when B-cells become abnormal., Diseases [C] - Cancer [C04]
 
 
2020-004360-26: Comparison of a fixed-duration treatment of acalabrutinib, venetoclax and obinutuzumab to a treatment of venetoclax and obinutuzumab in patients with high risk chronic lymphocytic leukemia Vergleich einer befristeten Therapie mit Acalabrutinib, Venetoclax und Obinutuzumab mit der Therapie von Venetoclax und Obinutuzumab bei Patienten mit chronischer lymphytischer Leukämie mit hohem Risiko

Not yet recruiting
3
178
Europe
Acalabrutinib, Obinutuzumab, Venetoclax, RO5072759, Capsule, hard, Concentrate for solution for infusion, Film-coated tablet, Calquence, Gazyvaro®, Venclyxto
German CLL Study Group (University of Cologne), AstraZeneca
Patients with previously untreated chronic lymphocytic leukemia with treatment requiring disease and at least one out of three risk factors (17p-deletion, TP53 mutation or Complex karyotype)., Patients with chronic lymphocytic leukaemia (blood cancer) in need of firstline treatment and at least one out of three risk factors., Diseases [C] - Cancer [C04]
 
 
ASCEND, NCT02970318 / 2015-004454-17: A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL

Checkmark 4-year follow up PFS data from ACEND trial for CLL at ASCO 2022
Jun 2022 - Jun 2022: 4-year follow up PFS data from ACEND trial for CLL at ASCO 2022
Checkmark From ASCEND trial for r/r CLL at ASH 2021
Dec 2021 - Dec 2021: From ASCEND trial for r/r CLL at ASH 2021
Checkmark From ASCEND trial for r/r CLL at EHA 2020
More
Active, not recruiting
3
310
Europe, Canada, US, RoW
Acalabrutinib (ACP-196), Rituximab, Idelalisib, Bendamustine
Acerta Pharma BV
Chronic Lymphocytic Leukemia
09/21
09/27
SOLIDARITY, NCT04647669: World Health Organization (WHO) COVID-19 Solidarity Trial for COVID-19 Treatments

Not yet recruiting
3
100
RoW
Remdesivir, Acalabrutinib, Interferon beta-1a, Standard of Care
The University of The West Indies
Covid19
11/21
12/21
BELLWAVE-011, NCT06136559: 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/)

Recruiting
3
1200
Europe, Canada, Japan, US, RoW
Nemtabrutinib, MK-1026, ARQ 531, Ibrutinib, Acalabrutinib
Merck Sharp & Dohme LLC
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
09/32
09/32
NCT06319456: A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL.

Recruiting
3
344
RoW
Lisaftoclax (APG-2575), Acalabrutinib, Fludarabine, Cyclophosphamide，CTX, Rituximab, Chlorambucil
Ascentage Pharma Group Inc.
CLL/SLL
08/27
08/28
NCT04075292: Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia

Calendar Oct 2024 - Dec 2024: Final data from trial for untreated CLL
Calendar Jan 2024 - Dec 2024: Data from trial for untreated CLL
Hourglass Jul 2022 - Sep 2022 : Last patient dosing of trial for untreated CLL
Active, not recruiting
3
155
RoW
Acalabrutinib, Rituximab, Chlorambucil
AstraZeneca
Untreated Chronic Lymphocytic Leukemia
11/24
11/24
NCT06428019: A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Not yet recruiting
3
120
NA
Venetoclax, ABT-199, Acalabrutinib, Obinutuzumab
AbbVie
Chronic Lymphocytic Leukemia
10/26
10/26
NCT04178798: Study to Investigate the Use of Acalabrutinib in the Treatment of Patients With Chronic Lymphocytic Leukemia

Active, not recruiting
3
22
Europe
Acalabrutinib 100 MG Oral Capsule
PETHEMA Foundation
Chronic Lymphocytic Leukemia- Binet Staging System
11/24
11/24
BRUIN-MCL-321, NCT04662255: Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

Active, not recruiting
3
500
Europe, Canada, Japan, US, RoW
Pirtobrutinib, LOXO-305, LY3527727, Ibrutinib, Imbruvica, Acalabrutinib, Calquence, Zanubrutinib, Brukinsa
Loxo Oncology, Inc., Eli Lilly and Company
Lymphoma, Mantle-Cell
12/25
07/26
ASSURE, NCT04008706 / 2019-001573-89: Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients

Active, not recruiting
3
552
Europe, Canada, US, RoW
Acalabrutinib, ACP-196
AstraZeneca, Parexel
Chronic Lymphocytic Leukemia
09/25
09/25
ECHO, NCT02972840 / 2015-005220-26: A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

Calendar Jan 2024 - Dec 2024: Acceptance of regulatory submission for 1L MCL (based on ECHO trial)
Jul 2023 - Dec 2023: Data from ECHO trial in previously untreated MCL
Hourglass Apr 2023 - Jun 2023 : Last patient dosing of ECHO trial (NCT02972840) in previously untreated MCL
Active, not recruiting
3
635
Europe, Canada, Japan, US, RoW
Acalabrutinib, ACP-196, Calquence, Bendamustine, Treanda, Bendeka, Rituximab, Rituxan, Rituxan Hycela, Placebo
Acerta Pharma BV, AstraZeneca
Lymphoma, Mantle Cell
10/25
10/25
NCT05197192 / 2020-004360-26: A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL

Recruiting
3
650
Europe
Obinutuzumab, Gazyva, Gazyvaro, Venetoclax, Venclexta, Venclyxto, Acalabrutinib, Calquence
German CLL Study Group, AstraZeneca
Chronic Lymphocytic Leukemia
05/26
02/27
NCT05211856: Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

Recruiting
3
780
Europe, Canada, US, RoW
Acalabrutinib, Calquence (acalabrutinib), Venetoclax, Venclyxto, Venclexta, Chemoimmunotherapy, Obinutuzumab, Gazyva, Gazyvaro
AstraZeneca
Chronic Lymphocytic Leukemia
01/27
01/27
ACE-CL-311, NCT03836261: Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

Calendar Jan 2027 - Mar 2027: Last patient dosing of P3 ACE-CL-311 trial in combination with venetoclax for previously untreated CLL
Calendar Jan 2024 - Dec 2024: Acceptance of regulatory submission in combination with venclexta and obinutuzumab for 1L CLL (based on AMPLIFY trial)
Calendar Jan 2024 - Dec 2024: Data from AMPLIFY trial in combination with Calquence and obinutuzumab for previously untreated CLL
Hourglass Jul 2022 - Dec 2022 : From P3 ACE-CL-311 trial in combination with Venclexta for 1L CLL
Active, not recruiting
3
984
Europe, Canada, US, RoW
Acalabrutinib, Calquence (acalabrutinib), Venetoclax, Venclyxto, Venclexta, Chemoimmunotherapy, Obinutuzumab, Gazyva, Gazyvaro
Acerta Pharma BV, AstraZeneca
Chronic Lymphocytic Leukemia
01/27
01/27
ESCALADE, NCT04529772 / 2019-001755-39: A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)

Calendar Jan 2024 - Dec 2024: Acceptance of regulatory submission for 1L DLBCL (based on ESCALADE trial)
Calendar Jan 2024 - Dec 2024: Data from ESCALADE trial in combination with R-CHOP for 1L DLBCL
Active, not recruiting
3
611
Europe, Canada, Japan, US, RoW
acalabrutinib, placebo, Prednisone, Rituximab, Cyclophosphamide, Vincristine, Doxorubicin
Acerta Pharma BV, AstraZeneca
Diffuse Large B-Cell Lymphoma
02/27
02/27
MAJIC, NCT05057494 / 2021-003936-10: A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Active, not recruiting
3
607
Europe, US, RoW
Acalabrutinib, Venetoclax, Obinutuzumab
AstraZeneca
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
07/27
04/29
ARCHED, NCT05820841: Acalabrutinib in Combination With R-miniCHOP in Older Adults With Untreated Diffuse Large B-Cell Lymphoma

Recruiting
3
330
Europe
R-miniCHOP + Acalabrutinib, R-miniCHOP
Universität des Saarlandes, University of Leipzig, University Hospital Regensburg, Wuerzburg University Hospital, University Hospital of Gießen and Marburg, Saarland University Medical Center, AstraZeneca
Large B-cell Lymphoma, Diffuse Large B Cell Lymphoma
04/28
12/28
2019-000270-29: The trial will investigate whether three months of treatment with a combination of two types of medication given as tablets can reduce the risk of infection and the need for regular CLL treatment when given to newly diagnosed CLL patients.

Not yet recruiting
2/3
212
Europe
Venetoclax 10 mg, Venetoclax 50 mg, Venetoclax 100 mg, Accalabrutinib, ACP-196, Tablet, Capsule, Venclyxto
Rigshopitalet/Copenhagen University Hospital, Novo Nordisk Foundation, Pharma Acerta, Abbvie
Chronic Lymphocytic Leukemia, Chronic cancer of white blood cells and bone marrow, Diseases [C] - Cancer [C04]
 
 
NCT03868722: Acalabrutinib and Venetoclax Treatment of Newly Diagnosed Patients With CLL at High Risk of Infection or Early Treatment

Recruiting
2/3
212
Europe
Acalabrutinib, Calquence, Venetoclax, Venclexta, Venclyxto
Rigshospitalet, Denmark, Stichting Hemato-Oncologie voor Volwassenen Nederland, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Karolinska Institutet
CLL
07/29
07/30

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