Actively Recruiting
Oxygen Study-Orelabrutinib Combined With Obinutuzumab(O2) for First-Line Treatment of Marginal Zone Lymphoma
Led by Huai'an First People's Hospital · Updated on 2024-08-22
51
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, prospective study. The main purpose is to evaluate the efficacy and safety of Orelabrutinib combined with Obinutuzumab for previously untreated MZL.
CONDITIONS
Official Title
Oxygen Study-Orelabrutinib Combined With Obinutuzumab(O2) for First-Line Treatment of Marginal Zone Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 6518 years, any gender
- Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT, SMZL, NMZL
- MZL that has progressed, recurred, or is unsuitable for local treatment after prior local therapy
- ECOG performance status between 0 and 2
- Indication for treatment based on symptoms, cytopenia, risk of organ damage, bulky disease, progression, or patient preference
- Adequate major organ function including blood counts, liver and kidney function, and coagulation within specified limits
- Expected survival time of at least 3 months
- Voluntary signed informed consent before screening
You will not qualify if you...
- Diagnosis of other malignant tumors unless cured with no recurrence or metastasis in the last 5 years
- Lymphoma with central nervous system involvement or transformed to a higher grade
- Active bleeding within 2 months before screening or use of anticoagulants with bleeding risk
- Major surgery within 6 weeks or minor surgery within 2 weeks before screening
- Active infection or uncontrolled HBV, positive HCV antibody, HIV/AIDS, or serious infections
- Mental or cognitive disorders limiting understanding or compliance
- Pregnant or lactating women and women unwilling to use contraception
- Need for continuous use of drugs strongly affecting cytochrome P450 CYP3A
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University#Huai'an First People's Hospital#
Huai'an, Jiangsu, China, 210000
Actively Recruiting
Research Team
C
Chunling Wang
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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