Actively Recruiting
A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma
Led by Fudan University · Updated on 2024-09-04
52
Participants Needed
2
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate whether maintenance therapy with Zanubrutinib monotherapy could improve the 2-year progression free survival (PFS) of patients with mantle cell lymphoma who had remission after first-line immunochemotherapy
CONDITIONS
Official Title
A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed mantle cell lymphoma
- Achieved complete or partial response after first-line immunochemotherapy (including CD20 monoclonal antibody for at least 4 cycles)
- Previous autologous hematopoietic stem cell transplantation allowed
- ECOG performance status 0-2
- Signed informed consent form
- Adequate organ function including hematopoietic, liver, renal, cardiac (LVEF 650%), and coagulation parameters within specified limits
You will not qualify if you...
- Allergy to human or mouse monoclonal antibodies or Zanubrutinib capsules and excipients
- Major surgery within 4 weeks prior to enrollment (except diagnostic surgery)
- Uncontrolled serious diseases including cardiovascular, cerebrovascular, blood coagulation disorders, severe infections
- Symptomatic congestive heart failure (NYHA III-IV), poorly controlled arrhythmias, uncontrolled hypertension
- Active peptic ulcer or hemorrhagic disease despite treatment
- Serious accompanying diseases interfering with treatment
- History of active malignant tumors except certain treated skin and bladder cancers without recurrence for 3 years
- Active interstitial pneumonia
- Alcohol or drug abuse
- Active chronic hepatitis B infection; latent or previous hepatitis B allowed with monitoring
- Active HIV or syphilis infections
- Pregnant or lactating women
- Live vaccine within 4 weeks before study drug administration
- Current continuous corticosteroid treatment >30 mg/day prednisone or equivalent for over 10 days
- Active autoimmune diseases requiring systemic treatment in past 2 years (with exceptions)
- Swallowing disorders preventing long-term oral medication
- Mental disorders affecting compliance or informed consent
- Investigator judgement deeming participant unsuitable for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
2
Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Y
Yizhen Liu, M.D., Ph.D.
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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