Actively Recruiting
Combination of Orelabrutinib and Obinutuzumab in Untreated Marginal Zone Lymphomas
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2024-07-22
45
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab a in untreated marginal zone lymphoma. It is planned to recruit 45 patients. The primary endpoint is the complete remission rate at 12 months.
CONDITIONS
Official Title
Combination of Orelabrutinib and Obinutuzumab in Untreated Marginal Zone Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT, splenic MZL, and nodal MZL
- Marginal zone lymphoma that has progressed, returned, or is unsuitable for local treatment after prior local therapy
- ECOG performance status score between 0 and 2
- Adequate major organ function as defined by specified blood counts, liver and kidney function tests, and coagulation parameters
- Life expectancy of at least 3 months
- Voluntary signing of informed consent before screening
You will not qualify if you...
- Current or prior other malignant tumors unless treated with no recurrence or metastasis for 5 years
- Lymphoma involving the central nervous system or transformed into a higher grade
- Uncontrollable or significant cardiovascular diseases including heart failure, unstable angina, recent myocardial infarction, arrhythmias, primary cardiomyopathies, significant QTc prolongation, symptomatic coronary artery disease, or difficult-to-control hypertension
- Active bleeding within 2 months before screening or use of anticoagulant drugs
- Active infection or uncontrolled hepatitis B or C, HIV/AIDS, or other serious infections
- Any other conditions deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
China Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, China, 300020
Actively Recruiting
Research Team
S
Shuhua Yi, Dr
CONTACT
L
Lugui Qiu, Dr
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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