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Efficacy and Safety of Zanubrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy and Safety of Zanubrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Safety and Efficacy of BGB-3111, a Bruton's Tyrosine Kinase (BTK) Inhibitor in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

NCT03206918•BeiGene

View on ClinicalTrials.gov

Summary

This was a single-arm, open-label, multi-center Phase 2 study in participants with histologically documented CLL/SLL who have relapsed after or refractory to ≥ 1 prior treatment regimen(s). The study is composed of an initial screening phase, a single-arm treatment phase, and a follow-up phase.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Confirmed diagnosis with at least one criterion for treatment according to International workshop on chronic lymphocytic leukemia (IWCLL)
•2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
•3. Measurable disease by contrast enhanced computerized tomography / magnetic resonance imaging (CT/MRI).
•4. Previously treated with a minimum of 1 prior line of standard chemotherapy-containing regimen (with completion of ≥2 treatment cycles).
•5. Documented failure to achieve at least partial response (PR) or documented disease progression after response to the most recent treatment regimen. Refractory disease is defined as treatment failure (stable disease, non-response, progressive disease \[PD\]) or disease progression within 6 months after the most recent prior therapy (Hallek et al, 2008).
•6. Neutrophils ≥ 0.75 x 109/L independent of growth factor support within 7 days of study entry
•7. Platelets ≥ 50 x 109/L, independent of growth factor support or transfusion within 7 days of study entry
•8. Creatinine clearance of ≥ 30 ml/min (as estimated by the Cockcroft-Gault equation or estimated glomerular filtration rate \[eGFR\] from the Modification of Diet in Renal Disease \[MDRD\])
•9. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x ULN
•10. Bilirubin ≤2 x ULN (unless documented Gilbert's syndrome)
+4 more criteria

Exclusion Criteria

•1. Current or history of central nervous system (CNS) lymphoma
•2. Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor
•3. Prior corticosteroids given in excess of prednisone 10 mg/day or its equivalent with antineoplastic intent within 7 days.
•4. Major surgery within 4 weeks of screening
•5. Not recovered from toxicity of any prior anti-cancer therapy to \<Grade 1 (except for alopecia, absolute neutrophil count (ANC) and platelets.
•6. History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent
•7. Currently active clinically significant cardiovascular disease
•8. QTcF \>480 msecs based on Fridericia's formula or other significant electrocardiogram abnormalities including second degree atrioventricular (AV) block Type II, or third degree AV block
•9. Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
•10. Active infection including infections requiring oral or intravenous anti-microbials
+6 more criteria

Locations (11)

Peking University Peoples Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Hospital of Jilin University

Changchun, Jilin, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

March 9, 2017

Primary Completion Date

June 15, 2018

Completion Date

September 10, 2020

Last Updated

October 26, 2024

Enrollment

ACTUAL participants

Conditions

Relapsed or Refractory Chronic Lymphocytic LeukemiaRelapsed or Refractory Small Lymphocytic Lymphoma

Interventions

Zanubrutinib

DRUG

Calquence CLL rr Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - All Patient Investigation

NCT04872621

Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma)

View study

COMPLETEDPHASE1

CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL

NCT03739554

Relapsed or Refractory Chronic Lymphocytic Leukemia

View study

COMPLETEDPHASE3

A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

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: October 26, 2024Data 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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