Actively Recruiting
A Clinical Study Evaluating the Safety and Efficacy of ZRMT Regimen in the Treatment of PCNSL
Led by Huai'an First People's Hospital · Updated on 2024-06-06
30
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
Sponsors
H
Huai'an First People's Hospital
Lead Sponsor
A
Affiliated Hospital of Nantong University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a prospective, multicenter, open-label, single-arm clinical trial evaluating the safety and efficacy of the ZRMT (Zanubrutinib-Rituximab-Methotrexate-Temozolomide) regimen in the treatment of primary central nervous system lymphoma (PCNSL) with diffuse large B-cell lymphoma. This study includes an induction phase for PCNSL ± ASCT and a sequential maintenance phase.
CONDITIONS
Official Title
A Clinical Study Evaluating the Safety and Efficacy of ZRMT Regimen in the Treatment of PCNSL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically diagnosed with primary central nervous system diffuse large B-cell lymphoma according to 2016 WHO classification.
- Age between 18 and 75 years, any gender.
- Performance status score (ECOG) of 0 to 1.
- Male and reproductive-age female participants must use contraception during the study and for 3 months after the last dose.
- Reproductive-age females must have a negative pregnancy test at screening.
- Expected survival of more than 3 months.
- Laboratory tests meet specified hematology, liver, kidney, and coagulation function criteria or receive supportive treatment by investigator's discretion.
- Ability and willingness to comply with study visits and procedures and provide informed consent.
You will not qualify if you...
- Allergy, resistance, or intolerance to any drugs in the treatment regimen.
- Use of investigational drugs or radiation therapy within the past 4 weeks.
- Major surgery within the past 4 weeks (excluding disease-related surgery).
- Severe infections within the past 4 weeks deemed unsuitable for treatment.
- History of stroke or intracranial hemorrhage within 3 months or active severe gastrointestinal bleeding.
- Pregnant or breastfeeding.
- Impaired cardiac function or significant heart diseases including recent myocardial infarction, congestive heart failure, viral myocarditis, symptomatic cardiac diseases requiring treatment, NYHA class II-IV heart function, or low ejection fraction.
- Known HIV infection, primary immunodeficiency, or active tuberculosis.
- Poorly controlled hypertension or diabetes.
- Active hepatitis B or C infection unless viral DNA/RNA is undetectable.
- History of malignant tumors affecting study or analysis (except certain localized or cured cancers).
- Active mental disorders, alcoholism, drug or substance abuse.
- Investigator deems participant unsuitable for study participation.
AI-Screening
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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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