Actively Recruiting
Clinical Study of OR for Second-line Treatment of Refractory MZL
Led by Lixia Sheng · Updated on 2024-06-11
39
Participants Needed
3
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test the overall response rate of Orelabrutinib combined with rituximab (OR regimen) for second-line treatment of relapsed/refractory marginal zone lymphoma.
CONDITIONS
Official Title
Clinical Study of OR for Second-line Treatment of Refractory MZL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, any gender
- Histological confirmation of marginal zone lymphoma or meeting diagnostic criteria for splenic marginal zone lymphoma
- At least one measurable lymph node lesion (>1.5 cm) or extranodal lesion (>1.0 cm) on CT or MRI
- Investigator requires systemic treatment for marginal zone lymphoma
- At least one previous systemic lymphoma treatment with no better than partial response or disease progression after prior effective treatment
- ECOG physical status score between 0 and 2
- Adequate organ function within 7 days prior to treatment including blood counts, liver and kidney function, coagulation, and heart function (LVEF ≥50%)
- Expected survival time of at least 3 months
- For men not sterilized: agree to use barrier contraception during treatment and for at least 3 months after last dose; female partners to use contraception
- For women not sterilized: agree to use effective contraception starting at least 28 days prior to consent, during treatment, and after last dose
- Signed informed consent before screening
You will not qualify if you...
- Previous treatment with Orelabrutinib plus rituximab with refractory response (no remission after 4 cycles)
- History of severe allergy to monoclonal antibody therapy or known allergy to study drugs
- Current or previous malignancy except cured with no recurrence for almost 5 years
- Lymphoma involvement of the central nervous system
- Uncontrolled or significant cardiovascular disease including heart failure NYHA grade II or above, recent myocardial infarction, significant arrhythmias, cardiomyopathies, clinically significant QTc prolongation, or difficult-to-control hypertension
- Active bleeding within 2 months prior to screening or use of anticoagulants
- Significant proteinuria (>2g/24h)
- History of deep vein thrombosis or pulmonary embolism
- Gastrointestinal abnormalities affecting drug absorption or total gastrectomy
- History of organ or bone marrow transplantation
- Major surgery within 6 weeks or minor surgery within 2 weeks before screening
- Active infection or uncontrolled hepatitis B, hepatitis C, HIV/AIDS, or other serious infections
- Current lung diseases like pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or drug-related pneumonia
- Previous treatment with BTK, BCR pathway inhibitors (e.g., PI3K, Syk), or BCL-2 kinase inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The Second Affiliated Hospital of Zhejiang University, Ningbo First Hospital
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
2
86-574-87085596
Ningbo, Zhejiang, China, 315010
Actively Recruiting
3
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315010
Actively Recruiting
Research Team
L
Lixia Sheng, Doctor
CONTACT
C
Chen
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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