Overview
VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma
Status:
Recruiting
Recruiting
Trial end date:
2025-04-22
2025-04-22
Target enrollment:
0
0
Participant gender:
All
All
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-line treatment for patients with marginal zone lymphoma.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Henan Cancer HospitalTreatments:
Bortezomib
Cyclophosphamide
Epirubicin
Prednisone
Rituximab
Criteria
Inclusion Criteria:1. Age between 18 to 70 years old (including 18 and 70)
2. Diagnosed as marginal zone lymphoma
3. No receiving chemotherapy before enrollment
4. 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
5. Having at least one measurable lesions
6. World health organization-Eastern Cooperative Oncology Group Performance tatus (ECOG)
0-1
7. Life expectancy no less than 3 months
8. enough main organ function
9. 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
10. Agreeing to sign the written informed consents
Exclusion Criteria:
1. Diagnosed as central nervous system lymphoma
2. World health organization-Eastern Cooperative Oncology Group Performance tatus (ECOG)
≥2
3. Other malignant tumor history or active malignant tumor need be treated
4. Serious surgery and trauma less than two weeks
5. Systemic therapy for serious acute/chronic infection
6. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart
infarction less than 6 months
7. Active tuberculosis. Patients suspected of active TB need to be examined for chest
X-ray, sputum and clinical symptoms and signs
8. HIV-positive, AIDS patients and untreated active hepatitis(HBV/HBV and HCV)
9. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12
months
10. Patients with a history of mental illness
11. Researchers determine unsuited to participate in this trial