Actively Recruiting
A Single Arm Study of Acalabrutinib Conbimed With Obinutuzumab in Chinese Patients With Previously Untreated CLL
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-05-09
89
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, prospective study to assess the efficacy and safety of acalabrutinib combined with obinutuzumab in subjects with previously untreated chronic lymphocytic leukemia.
CONDITIONS
Official Title
A Single Arm Study of Acalabrutinib Conbimed With Obinutuzumab in Chinese Patients With Previously Untreated CLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age or older
- ECOG performance status of 0, 1, or 2 with no recent deterioration
- Diagnosis of CD20+ CLL meeting specific diagnostic criteria
- Active disease requiring treatment based on iwCLL 2018 criteria
- Specific laboratory parameters including ANC, platelet count, liver enzymes, bilirubin, and creatinine clearance
- Agreement to use effective contraception if sexually active and able to bear children
- Ability to participate in all study procedures and swallow capsules
- Ability to understand and provide informed consent
You will not qualify if you...
- Severe or uncontrolled systemic diseases making participation unsafe
- Prior systemic treatment for CLL
- Known CNS lymphoma or leukemia
- Known prolymphocytic leukemia or Richter's syndrome
- Uncontrolled autoimmune anemia or thrombocytopenia
- Recent use of high-dose corticosteroids
- Major surgery within 30 days before study drug
- History of prior malignancy affecting study compliance except certain treated cancers
- Significant cardiovascular disease or recent myocardial infarction
- History of progressive multifocal leukoencephalopathy (PML)
- Recent use of investigational drugs
- Gastrointestinal conditions affecting drug absorption
- Recent live virus vaccination
- History of HIV infection
- Active significant infections
- Active hepatitis B or C infection
- Recent stroke or intracranial hemorrhage
- History of bleeding disorders
- Use of warfarin or similar anticoagulants
- Use of strong CYP3A inhibitors or inducers near study start
- Pregnancy or breastfeeding
- Participation in another therapeutic clinical trial
- Use of proton-pump inhibitors
- Life-threatening illness or organ dysfunction compromising safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjin, Jiangsu, China, 210029
Actively Recruiting
Research Team
J
Jianyong Li, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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