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ACTIVE NOT RECRUITING
NCT04529772
PHASE3

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

Sponsor: Acerta Pharma BV

View on ClinicalTrials.gov

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 ≤75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma.

Official title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

611

Start Date

2020-10-08

Completion Date

2027-02-22

Last Updated

2026-10-13

Healthy Volunteers

No

Interventions

DRUG

acalabrutinib

Investigational Product

DRUG

placebo

Placebo comparator

DRUG

Prednisone

Investigational Product

DRUG

Rituximab

Investigational Product

DRUG

Cyclophosphamide

Investigational Product

DRUG

Vincristine

Investigational Product

DRUG

Doxorubicin

Investigational Product

Locations (245)

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Irvine, California, United States

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Aurora, Colorado, United States

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Norwich, Connecticut, United States

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Fort Myers, Florida, United States

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Orlando, Florida, United States

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St. Petersburg, Florida, United States

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Tallahassee, Florida, United States

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West Palm Beach, Florida, United States

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Fort Wayne, Indiana, United States

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Des Moines, Iowa, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Grand Rapids, Michigan, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Albany, New York, United States

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New York, New York, United States

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New York, New York, United States

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Stony Brook, New York, United States

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Charlotte, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Nashville, Tennessee, United States

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Fort Sam Houston, Texas, United States

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Lubbock, Texas, United States

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Salem, Virginia, United States

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Adelaide, Australia

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Camperdown, Australia

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Darlinghurst, Australia

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Heidelberg, Australia

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Hobart, Australia

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Kogarah, Australia

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Nedlands, Australia

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Westmead, Australia

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Linz, Austria

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Wels, Austria

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Antwerp, Belgium

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Bruges, Belgium

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La Louvière, Belgium

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Goiânia, Brazil

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Passo Fundo, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Ribeirão Preto, Brazil

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Rio de Janeiro, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Vancouver, British Columbia, Canada

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Toronto, CA, Canada

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Winnipeg, Manitoba, Canada

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London, Ontario, Canada

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Lévis, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Ottawa, Canada

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Toronto, Canada

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Beijing, China

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Beijing, China

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Changchun, China

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Chengdu, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Hangzhou, China

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Hangzhou, China

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Harbin, China

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Jinan, China

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Luoyang, China

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Nanchang, China

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Nanning, China

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Shanghai, China

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Shanghai, China

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Shenyang, China

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Shenyang, China

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Shijiazhuang, China

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Suzhou, China

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Tianjin, China

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Tianjin, China

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Wuhan, China

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Wuhan, China

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Xiamen, China

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Zhengzhou, China

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Brno, Czechia

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Hradec Králové, Czechia

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Ostrava - Poruba, Czechia

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Pilsen, Czechia

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Prague, Czechia

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Prague, Czechia

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Brest, France

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Caen, France

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Marseille, France

And 145 more locations on ClinicalTrials.gov