Clinical trial · Interventional
VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma
A Single Arm, Multi-center, Phase II Clinical Trial of VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma
NCT04433156CI-TRIAL-00107755completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VR-CAP
- description
- Rituximab, 375 mg/m2, Intravenous administration on day 0, Bortezomib, 1.3 mg/m2 hypodermic injection on day 1 and 4, combined with regimen: Cyclophosphamide, Epirubicin, and Prednisone: repeated every 3 weeks, up to 6 cycles.
- interventionNames
- Drug: Bortezomib
- Drug: Rituximab
- Drug: Epirubicin
- Drug: Cyclophosphamide
- Drug: Prednisone
Primary outcomes (1)
- measure
- 2-year progression-free survival
- timeFrame
- from the beginning day of the first cycle (each cycle is 21 days) of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment
- description
- the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.