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.

Detailed Description:

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

Official Title

Glossary term:

Title

The official title of a protocol used to identify a clinical study or a short title written in language intended for the lay public.

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤70 Years With Previously Untreated Non-GCB DLBCL

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

Phase

Glossary term:

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies). Phase 1: Clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants. Phase 2: Clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. Phase 3: Clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants. Phase 4: Clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use. Not Applicable: Trials without FDA-defined phases, including trials of devices or behavioral interventions.

Phase 3

Other Study ID Numbers

Glossary term:

Other study IDs

Identifiers or ID numbers other than the NCT number that are assigned to a clinicalstudy by the study's sponsor, funders, or others. These numbers may include unique identifiers from othertrial registries and National Institutes of Health grant numbers.

D8227C00001

Intervention / Treatment

Glossary term:

Intervention/treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Drug: acalabrutinib
Drug: placebo
Drug: Prednisone
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Doxorubicin

Study Start (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.

Oct 08, 2020

Primary Completion (Anticipated)

Glossary term:

Primary completion date

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.

Aug 31, 2026

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.

Aug 31, 2026

First Submitted Date

Glossary term:

First submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).

Aug 25, 2020

First Submitted that Met QC Criteria

Glossary term:

First submitted that met QC criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.

Aug 25, 2020

First Posted (Actual)

Glossary term:

First posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.

Aug 28, 2020

Last Update Submitted that Met MQ Criteria

Glossary term:

Last update submitted that met QC criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.

Nov 17, 2022

Last Update Posted (Actual)

Glossary term:

Last update posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date)and the last update posted date.

Nov 18, 2022

Other important Dates

Contacts and Locations

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

Get Directions

Contacts and Locations

United States

Get Directions

Contacts

Study Contact

Glossary term:

Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Name: AstraZeneca Clinical Study Information Center

Phone Number: 1-877-240-9479

Email: information.center@astrazeneca.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments. For general information about clinical research, read Guides to Clinical Trials.

Eligibility Criteria

Ages Eligible for Study:

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

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.

Sexes Eligible for Study:

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

Description:

Inclusion Criteria:

Men and women, age ≥18 and ≤70 years
Pathologically confirmed DLBCL, sufficient diagnostic material should be available to forward to a central laboratory for gene expression profiling and pathology review.
No prior treatment for DLBCL
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
International Prognostic Index (IPI) score of 1 to 5
Disease Stage II to IV by the Ann Arbor Classification
Adequate organ and marrow function
Agreement to use highly effective forms of contraception during the study and 12 months after the last dose of rituximab

Exclusion Criteria:

Evidence of severe or uncontrolled systemic diseases
Known history of a bleeding diathesis (i.e., haemophilia, von Willebrand disease)
History of stroke or intracranial haemorrhage in preceding 6 months.
Known CNS lymphoma or leptomeningeal disease
Known primary mediastinal lymphoma
Known High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Prior history of indolent lymphoma or CLL
History of or ongoing confirmed PML
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
Uncontrolled active systemic fungal, bacterial, viral, or other infection
Prior anthracycline use ≥150 mg/m2

Study Plan

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

How is the study designed?

Design Details:

Primary Purpose:

Treatment

Allocation:

Randomized

Interventional Model:

Parallel Assignment

Interventional Model Description:

Double-blind Randomised Placebo-controlled Study

Number of Arms:

Arms and Interventions:

Participant Group / Arm

Glossary term:

Arm

A group or subgroup of participants in a clinical trial that receives a specificintervention/treatment, or no intervention, according to the trial's protocol.

Intervention / Treatment

Glossary term:

Intervention/treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Experimental: acalabrutinib + R-CHOP

Acalabrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)

Experimental: acalabrutinib + R-CHOP

Acalabrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)

Drug: acalabrutinib

Investigational Product

Drug: acalabrutinib

Investigational Product

Drug: Prednisone

Investigational Product

Drug: Prednisone

Investigational Product

Drug: Rituximab

Investigational Product

Drug: Rituximab

Investigational Product

Drug: Cyclophosphamide

Investigational Product

Drug: Cyclophosphamide

Investigational Product

Drug: Vincristine

Investigational Product

Drug: Vincristine

Investigational Product

Drug: Doxorubicin

Investigational Product

Drug: Doxorubicin

Investigational Product

Placebo Comparator: placebo + R-CHOP

Placebo plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)

Placebo Comparator: placebo + R-CHOP

Placebo plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)

Drug: placebo

Placebo comparator

Drug: placebo

Placebo comparator

Drug: Prednisone

Investigational Product

Drug: Prednisone

Investigational Product

Drug: Rituximab

Investigational Product

Drug: Rituximab

Investigational Product

Drug: Cyclophosphamide

Investigational Product

Drug: Cyclophosphamide

Investigational Product

Drug: Vincristine

Investigational Product

Drug: Vincristine

Investigational Product

Drug: Doxorubicin

Investigational Product

Drug: Doxorubicin

Investigational Product

What is the study measuring?

Primary Outcome Measures

Glossary term:

Primary outcome measure

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.