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Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia

A Randomized, Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Acalabrutinib Versus Chlorambucil Plus Rituximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia

NCT04075292•AstraZeneca

View on ClinicalTrials.gov

Summary

This is a randomized, multicenter, open-label, Phase 3 study to evaluate the efficacy and safety of Acalabrutinib versus Chlorambucil plus Rituximab in subjects with Previously Untreated Chronic Lymphocytic Leukemia.

Detailed Description

Patients be randomized in a 1:1 ratio into 2 arms to receive either acalabrutinib monotherapy (Arm A) or rituximab in combination with chlorambucil (Arm B). The primary objective of this study is to compare the efficacy of acalabrutinib relative to chlorambucil plus rituximab in subjects with previously untreated chronic lymphocytic leukemia without del(17p) or TP53 mutation.

Eligibility

Age

18 - 130 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men and women: (a) ≥65 years of age OR (b) \>18 and \<65 years of age, provided that they meet at least one of the following criteria: (i) Creatinine clearance 30 to 69 mL/min using the Cockcroft-Gault equation (iwCLL guidelines) (ii) A score higher than 6 on the Cumulative Illness Rating Score-Geriatric (CIRS G)
•ECOG performance status of 0, 1, or 2
•Diagnosis of CLL that meets published diagnostic criteria (Hallek 2018)
•Active disease per IWCLL 2018 criteria that requires treatment
•Adequate bone marrow function
•Adequate renal and hepatic function

Exclusion Criteria

•Known detected del(17p) or TP53 mutation
•Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (eg, Richter's transformation, PLL, or diffuse large B cell lymphoma \[DLBCL\]), or central nervous system (CNS) involvement by leukemia
•History of prior malignancy except for the following: (a) Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study (b) Other cancers not specified above which have been curatively treated by surgery and/or radiation therapy from which subject is disease-free for ≥3 years without further treatment
•Significant cardiovascular disease
•Known history of infection with human immunodeficiency virus (HIV)
•Serologic status reflecting active hepatitis B or C infection
•Any active systemic infection (eg, bacterial, viral, or fungal infection) requiring systemic treatment
•History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
•Major surgical procedure within 30 days of first dose of study drug
•Any prior CLL-specific therapies
+3 more criteria

Locations (46)

Research Site

Beijing, China

Research Site

Changchun, China

Research Site

Changsha, China

Research Site

Changzhou, China

Research Site

Guangzhou, China

Research Site

Guangzhou, China

Research Site

Guiyang, China

Research Site

Hangzhou, China

Research Site

Hefei, China

Research Site

Hefei, China

Key Dates

Start Date

January 20, 2020

Primary Completion Date

January 3, 2024

Completion Date

January 1, 2027

Last Updated

March 5, 2026

Enrollment

155

ACTUAL participants

Conditions

Untreated Chronic Lymphocytic Leukemia

Interventions

Acalabrutinib

DRUG

Rituximab

DRUG

Chlorambucil

DRUG

STop and Restart Acalabrutinib In fRail Patients With Previously Untreated Chronic Lymphocytic Leukemia

NCT04963946

Untreated Chronic Lymphocytic Leukemia

View study

COMPLETEDNA

Cholecalciferol in Newly Diagnosed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia With Vitamin D Deficiency

NCT02553447

Chronic Lymphocytic LeukemiaNon-Hodgkin Lymphoma+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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