Acalabrutinib

Generic Name: Acalabrutinib

Brand Names: Calquence

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₃N_₇O_₂

CAS Number: 1420477-60-6

Unique Ingredient Identifier: I42748ELQW

Background: To date, acalabrutinib has been used in trials studying the treatment of B-All, myelofibrosis, ovarian cancer, multiple myeloma, and Hodgkin lymphoma, among others.
...

Indication: Acalabrutinib is currently indicated for the treatment of adult patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy. It has also been recently approved for chronic lymphocytic leukemia and small lymphocytic lymphoma.

Associated Conditions: Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma (MCL), Small Lymphocytic Lymphoma

Associated Therapies: -

Clinical Trials

A Study to Evaluate the Effect of [14C]Acp-196 (Acalabrutinib) in Healthy Adult Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Acalabrutinib
Drug: Microtracer [14C]ACP-196

First Posted Date: 2021-05-24

Last Posted Date: 2021-05-24

Lead Sponsor: Acerta Pharma BV

Target Recruit Count: 14

Registration Number: NCT04898101

Locations: 🇺🇸
Covance Clinical Research Unit, Inc., Madison, Wisconsin, United States

Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas

Phase 2

Recruiting

Conditions: Grade 2 Follicular Lymphoma
Marginal Zone Lymphoma
Grade 1 Follicular Lymphoma
Grade 3a Follicular Lymphoma
Indolent Non-Hodgkin Lymphoma
Lymphoplasmacytic Lymphoma
Lymphoproliferative Disorder
Mantle Cell Lymphoma

Interventions: Drug: Acalabrutinib
Biological: Obinutuzumab
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

First Posted Date: 2021-05-12

Last Posted Date: 2024-07-05

Lead Sponsor: Emory University

Target Recruit Count: 49

Registration Number: NCT04883437

Locations: 🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

Avo in R/R and Previously Untreated MCL

Phase 1

Recruiting

Conditions: Mantle Cell Lymphoma
Refractory Lymphoma

Interventions: Drug: Acalabrutinib
Drug: Venetoclax
Drug: Obinutuzumab

First Posted Date: 2021-04-22

Last Posted Date: 2024-10-23

Lead Sponsor: Austin I Kim

Target Recruit Count: 53

Registration Number: NCT04855695

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Acalabrutinib and Duvelisib for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

Phase 1

Withdrawn

Conditions: Refractory Marginal Zone Lymphoma
Refractory Nodal Marginal Zone Lymphoma
Refractory Splenic Marginal Zone Lymphoma
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

Interventions: Drug: Acalabrutinib
Drug: Duvelisib

First Posted Date: 2021-04-08

Last Posted Date: 2022-06-07

Lead Sponsor: Narendranath Epperla

Registration Number: NCT04836832

Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma

Phase 2

Active, not recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Acalabrutinib
Biological: Ublituximab
Drug: Umbralisib

First Posted Date: 2021-03-05

Last Posted Date: 2024-12-02

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 12

Registration Number: NCT04783415

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

Acalabrutinib and Rituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma

Phase 2

Active, not recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Acalabrutinib
Biological: Rituximab

First Posted Date: 2021-02-21

Last Posted Date: 2024-11-27

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 53

Registration Number: NCT04765111

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

A Study on Limiting Treatment Time With Acalabrutinib Combined With Obinutuzumab in People With CLL or SLL

Phase 2

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: Acalabrutinib
Drug: Obinutuzumab

First Posted Date: 2021-01-25

Last Posted Date: 2024-11-04

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 55

Registration Number: NCT04722172

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (All protocol activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States
🇺🇸
Memorial Sloan Kettering Westchester (All protocol activities), Harrison, New York, United States

and more 5 locations

Copanlisib Plus Ibrutinib or Acalabrutinib in R/R CLL

Phase 2

Withdrawn

Conditions: Chronic Lymphocytic Leukemia (CLL)

Interventions: Drug: Ibrutinib
Drug: Copanlisib
Drug: Acalabrutinib

First Posted Date: 2020-12-28

Last Posted Date: 2023-01-17

Lead Sponsor: Inhye Ahn

Registration Number: NCT04685915

Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

Phase 3

Active, not recruiting

Conditions: Lymphoma, Mantle-Cell

Interventions: Drug: Ibrutinib
Drug: Pirtobrutinib
Drug: Acalabrutinib
Drug: Zanubrutinib

First Posted Date: 2020-12-10

Last Posted Date: 2024-05-13

Lead Sponsor: Loxo Oncology, Inc.

Target Recruit Count: 500

Registration Number: NCT04662255

Locations: 🇺🇸
Mercy Health-Paducah Medical Oncology and Hematology, Paducah, Kentucky, United States
🇺🇸
Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
🇺🇸
Seattle Cancer Care Alliance, Seattle, Washington, United States

and more 220 locations

Early Intervention With Acalabrutinib in Patients With High Risk CLL

Phase 2

Withdrawn

Conditions: Chronic Lymphocytic Leukemia
CLL/SLL

Interventions: Drug: Acalabrutinib

First Posted Date: 2020-12-09

Last Posted Date: 2022-04-05

Lead Sponsor: Weill Medical College of Cornell University

Registration Number: NCT04660045

Locations: 🇺🇸
Weill Cornell Medicine, New York, New York, United States

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy