A Combination of Acalabrutinib With R‑CHOP in Subjects With Previously Untreated Non‑GCB DLBCL (ACE‑LY‑312)

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Information provided by:

Acerta Pharma BV

Last updated:

11/18/2022

Trial identifier:

NCT04529772

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Simplified Study Description Detailed Study Description

Study Description

Brief summary:

Phase 3 randomized, double-blind, placebo-controlled, study assessing the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP in subjects ≤70 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma.

Study Recruitment Status:

Glossary term:

Recruitment status

Not yet recruiting: The study has not started recruiting participants. Recruiting: The study is currently recruiting participants. Enrolling by invitation: The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate. Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled. Suspended: The study has stopped early but may start again. Terminated: The study has stopped early and will not start again. Participants are no longer being examined or treated. Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred). Withdrawn: The study stopped early, before enrolling its first participant. Unknown: A study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been last verified within the past 2 years.

Recruiting

Age Eligible:

Glossary term:

Age

A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups: The age groups are: Child (birth–17) Adult (18–64) Older adult (65+)

18 Years - 70 Years

Sexes Eligible:

Glossary term:

Sex

A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.

All

Study Accepts Healthy Volunteers:

Glossary term:

Accepts Healthy Volunteers

A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.

Intervention Being Studied:

Drug: acalabrutinib

Drug: placebo

Drug: Prednisone

Drug: Rituximab

Drug: Cyclophosphamide

Drug: Vincristine

Drug: Doxorubicin

Type of Study:

Glossary term:

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access. Interventional studies (clinical trials): A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. Observational studies: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific intervention/treatment. A patient registry is a type of observational study. Expanded access: A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.

Interventional

Enrollment (Anticipated):

Glossary term:

Enrollment

The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.

600 participants

Sponsor:

Glossary term:

Sponsor

The organization or person who initiates the study and who has authority and control over the study.

Acerta Pharma BV

Study Locations (38):

Research Site

Grand Rapids, Michigan, United States, 49503

Research Site

Portland, Oregon, United States, 97239

Research Site

Orange, California, United States, 92868

Research Site

Denver, Colorado, United States, 80218

Research Site

Fort Myers, Florida, United States, 33901

Research Site

West Palm Beach, Florida, United States, 33401

Research Site

Billings, Montana, United States, 59102

Research Site

Omaha, Nebraska, United States, 68198

Research Site

Nashville, Tennessee, United States, 37203

Research Site

Fort Worth, Texas, United States, 76104

Research Site

New York, New York, United States, 10065

Research Site

Pittsburgh, Pennsylvania, United States, 15212

Research Site

Lubbock, Texas, United States, 79410

Research Site

Portland, Oregon, United States, 97213

Research Site

Tucson, Arizona, United States, 85711

Research Site

New York, New York, United States, 10028

Research Site

Norwich, Connecticut, United States, 06360

Research Site

Chattanooga, Tennessee, United States, 37404

Research Site

Little Rock, Arkansas, United States, 72205

Research Site

Miami, Florida, United States, 33176

Research Site

Albany, New York, United States, 12208

Research Site

Salem, Virginia, United States, 24153

Research Site

Wichita, Kansas, United States, 67214

Research Site

New Orleans, Louisiana, United States, 70121

Research Site

Aurora, Colorado, United States, 80012

Research Site

Saint Petersburg, Florida, United States, 33705-1449

Research Site

Tallahassee, Florida, United States, 32308-5304

Research Site

Fort Wayne, Indiana, United States, 46845

Research Site

Des Moines, Iowa, United States, 50309

Research Site

Louisville, Kentucky, United States, 40207

Research Site

Kansas City, Missouri, United States, 64132

Research Site

Saint Louis, Missouri, United States, 63129

Research Site

Stony Brook, New York, United States, 11795

Research Site

Eugene, Oregon, United States, 97401

Research Site

Fort Sam Houston, Texas, United States, 78234

Research Site

Nyack, New York, United States, 10960

Research Site

Irvine, California, United States, 92618

Research Site

Duluth, Minnesota, United States, 55802

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Study Start Date (Actual):

Glossary term:

Study start date

The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.

October 08, 2020

Study Completion (Anticipated):

Glossary term:

Study completion date

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.

August 31, 2026

Study Contacts:

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Placebo Arm:

Glossary term:

Placebo comparator arm

An arm type in which a group of participants receives a placebo during a clinical trial.

Yes

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Age Eligible: Glossary term: Age A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups: The age groups are: Child (birth–17) Adult (18–64) Older adult (65+)

Sexes Eligible: Glossary term: Sex A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.

Study Accepts Healthy Volunteers: Glossary term: Accepts Healthy Volunteers A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.

Intervention Being Studied:

Enrollment (Anticipated): Glossary term: Enrollment The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.

Sponsor: Glossary term: Sponsor The organization or person who initiates the study and who has authority and control over the study.

Study Locations (38):

Study Start Date (Actual): Glossary term: Study start date The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.

Study Contacts:

Placebo Arm: Glossary term: Placebo comparator arm An arm type in which a group of participants receives a placebo during a clinical trial.

Age Eligible:

Glossary term:

Age

A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups: The age groups are: Child (birth–17) Adult (18–64) Older adult (65+)

Sexes Eligible:

Glossary term:

Sex

A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.

Study Accepts Healthy Volunteers:

Glossary term:

Accepts Healthy Volunteers

A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.

Enrollment (Anticipated):

Glossary term:

Enrollment

The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.

Sponsor:

Glossary term:

Sponsor

The organization or person who initiates the study and who has authority and control over the study.

Study Start Date (Actual):

Glossary term:

Study start date

The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.

Placebo Arm:

Glossary term:

Placebo comparator arm

An arm type in which a group of participants receives a placebo during a clinical trial.