VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma

NCT04433156 | Completed Phase 2 DMC

• 1 other identifier: HNSZLYYNHL03
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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-line treatment for patients with marginal zone lymphoma.

Conditions

Marginal Zone Lymphoma

Keywords

Marginal Zone Lymphoma; VR-CAP

Outcome Measures

Primary Outcomes (1)

• 2-year progression-free survival

  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

  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

Secondary Outcomes (3)

• objective response rate

  every 6 weeks from the beginning day of the first cycle (each cycle is 21 days) of induction chemotherapy treatment and every 8 weeks from the day of the first cycle of maintenance treatment to 18 months after last patient's enrollment

• overall survival

  from the beginning day of the first cycle (each cycle is 21 days) of treatment to the date of death from any cause, assessed up to 5 years

• incidence and relationship with study drugs of grade 3-4 adverse events

  from the beginning day of the first cycle (each cycle is 21 days) of treatment to 6 months after last patient's enrollment

Study Arms (1)

VR-CAP

EXPERIMENTAL

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.

Drug: Bortezomib; Drug: Rituximab; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Prednisone

Interventions

Bortezomib DRUG

1.3 mg/m2, hypodermic injection on day 1 and day 4 of each 3-week cycle until disease progression/stable disease after 2/4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.

Also known as: Bortezomib Injection

VR-CAP

Rituximab DRUG

375 mg/m2, Intravenous administration on day 0 of each 3-week cycle until disease progression/stable disease after 2/4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.

Also known as: RiTUXimab Injection

VR-CAP

Epirubicin DRUG

70 mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2/4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.

Also known as: Epirubicin hydrochloride

VR-CAP

Cyclophosphamide DRUG

750 mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2/4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.

Also known as: Cyclophosphamide Injection

VR-CAP

Prednisone DRUG

100mg, oral administration on day 1 to 5 of each 3-week cycle until disease progression/stable disease after 2/4 cycles treatment or unacceptable toxicity develops, up to 6 cycles

Also known as: Prednisone Oral Product

VR-CAP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

Bortezomib; Rituximab; Epirubicin; Cyclophosphamide; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Yanyan Liu, M.D. Ph.D

  Henan Cancer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: April 22, 2020
• Primary Completion: July 31, 2025
• Study Completion: March 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)