Status:
UNKNOWN
VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Marginal Zone Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of VR-CAP (Bortezomib and Rituximab-Cyclophosphamide, Epirubicin and Prednisone) in the first...
Detailed Description
Marginal zone lymphoma (MZL) is a relatively common group of non-Hodgkin's lymphoma (NHL). The incidence rate is only inferior to diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL). Cu...
Eligibility Criteria
Inclusion
- Age between 18 to 70 years old (including 18 and 70)
- Diagnosed as marginal zone lymphoma
- No receiving chemotherapy before enrollment
- Indications for treatment: 1) symptoms related to tumor; 2) end-organ function damage; 3) large mass; 4) continuous or rapid progress of disease; 5) patient's willingness
- Having at least one measurable lesions
- World health organization-Eastern Cooperative Oncology Group Performance tatus (ECOG) 0-1
- Life expectancy no less than 3 months
- enough main organ function
- Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
- Agreeing to sign the written informed consents
Exclusion
- Diagnosed as central nervous system lymphoma
- World health organization-Eastern Cooperative Oncology Group Performance tatus (ECOG) ≥2
- Other malignant tumor history or active malignant tumor need be treated
- Serious surgery and trauma less than two weeks
- Systemic therapy for serious acute/chronic infection
- Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
- Active tuberculosis. Patients suspected of active TB need to be examined for chest X-ray, sputum and clinical symptoms and signs
- HIV-positive, AIDS patients and untreated active hepatitis（HBV/HBV and HCV）
- Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
- Patients with a history of mental illness
- Researchers determine unsuited to participate in this trial
Key Trial Info
Start Date :
April 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 22 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04433156
Start Date
April 22 2020
End Date
April 22 2025
Last Update
May 18 2023
Active Locations (1)
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1
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, China