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Clinical Trials in China / NCT03836261
Active, not recruiting Phase 3

Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

NCT03836261 · tracked via the Priya Life Science China tracker
Sponsor
Acerta Pharma BV
Phase
Phase 3
Started
2019-02-25
Last updated
2024-12-27

Condition(s) studied

Chronic Lymphocytic Leukemia

Investigational drug(s) / intervention(s)

AcalabrutinibVenetoclaxChemoimmunotherapyObinutuzumab

Acalabrutinib: Acalabrutinib,

Venetoclax: Venetoclax

Chemoimmunotherapy: fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR)

Obinutuzumab: Obinutuzumab

Study summary

The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria: * Men and women ≥18 years of age. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Diagnosis of CLL that meets published diagnostic criteria (Hallek et al. 2018) * Active disease per IWCLL 2018 criteria that requires treatment. * Participants must use highly effective birth control throughout the study. Exclusion Criteria: * Any prior CLL-specific therapies. * Detected del(17p) or TP53 mutation. * Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (e.g., Richter's transformation, prolymphocytic leukemia \[PLL\], or diffuse large B cell lymphoma \[DLBCL\]), or central nervous system (CNS) involvement by leukemia. * History of confirmed progressive multifocal leukoencephalopathy (PML). * Received any investigational drug within 30 days before first dose of study drug. * Major surgical procedure within 30 days before the first dose of study drug. * Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 or 4 cardiac disease. Note: Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study. * Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach, or extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass. * Received a live virus vaccination within 28 days of first dose of study drug. * Known history of infection with human immunodeficiency virus (HIV). * Serologic status reflecting active hepatitis B or C infection. * History of known hypersensitivity or anaphylactic reactions to study drugs or excipients. * History of stroke or intracranial hemorrhage within 6 months before first dose of study drug. * Known bleeding disorders. * Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists. * Female participants must not be breastfeeding or pregnant. * Concurrent participation in another therapeutic clinical trial.

Primary outcome measure(s)

Trial sites (170)

FacilityCityRegionStatus
Research Site Los Angeles California
Research Site Redondo Beach California
Research Site Fort Wayne Indiana
Research Site Wichita Kansas
Research Site Louisville Kentucky
Research Site New Orleans Louisiana
Research Site Baltimore Maryland
Research Site Boston Massachusetts
Research Site New York New York
Research Site Charlotte North Carolina
Research Site Canton Ohio
Research Site Pittsburgh Pennsylvania
Research Site Pittsburgh Pennsylvania
Research Site Fort Sam Houston Texas
Research Site Spokane Washington
Research Site Tacoma Washington
Research Site Buenos Aires Argentina
Research Site Buenos Aires Argentina
Research Site Capital Federal Argentina
Research Site Córdoba Argentina
Research Site Adelaide Australia
Research Site Darlinghurst Australia
Research Site Heidelberg Australia
Research Site Kogarah Australia
Research Site Melbourne Australia
Research Site Nedlands Australia
Research Site Waratah Australia
Research Site Woolloongabba Australia
Research Site Krems Austria
Research Site Salzburg Austria
Research Site Vienna Austria
Research Site Goiânia Brazil
Research Site Porto Alegre Brazil
Research Site Porto Alegre Brazil
Research Site Porto Alegre Brazil
Research Site Rio de Janeiro Brazil
Research Site Rio de Janeiro Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil

+ 130 more sites — see the full list on the official registry below.

On this site

📄 Calquence (acalabrutinib) drug profile → 📄 Venclexta (venetoclax) drug profile →

More Acerta Pharma BV trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03836261 on ClinicalTrials.gov ↗ ← All trials in China