Actively Recruiting
A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma
Led by Ruijin Hospital · Updated on 2023-11-29
23
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of Zanubrutinib given in combination with bendamustine and rituximab in (elderly or TP53 alterations or chemotherapy intolerance) patients with newly diagnosed mantle cell lymphoma.
CONDITIONS
Official Title
A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histopathologically confirmed mantle cell lymphoma according to the 5th edition WHO classification
- Presence of del(17p)/TP53 mutation or age 65 years or older; or under 65 years but chemotherapy intolerance
- Life expectancy longer than 3 months as judged by investigator
- Creatinine Clearance Rate (CCR) at least 50 mL/min or estimated Glomerular Filtration Rate (eGFR) at least 60 mL/(min·1.73 m²)
- International Normalized Ratio (INR) of 1.5 or less and activated Partial Thromboplastin Time (aPTT) 1.5 times or less than the upper limit of normal
- Left Ventricular Ejection Fraction (LVEF) 50% or higher
- Willingness to provide written informed consent personally or through a legal representative
You will not qualify if you...
- Pregnant or breastfeeding women
- Known infection with Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), including detectable HBV-DNA
- Having acquired or congenital immunodeficiency
- Having congestive heart failure within 6 months before enrollment, with NYHA heart function class III or IV, or LVEF below 50%
- Known allergy to any ingredients of the study drugs
- Diagnosed with or being treated for any cancer other than lymphoma
- Having severe infections
- Substance abuse or medical, psychological, or social conditions that could interfere with study participation or result evaluation
- Considered unsuitable for the study group by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200020
Actively Recruiting
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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