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NCT Number: NCT04433156

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

About this study

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). Currently, NCCN guidelines recommend same treatment plan of FL like R-CHOP as the primary treatment for MZL. However, due to the great difference in cell origin and biological characteristics between FL and MZL, some patients can not achieve complete remission or relapse quickly after standard first-line treatment. A number of phase II clinical studies have evaluated the good efficacy of rituximab combined with chemotherapy in the treatment of MZL. Previous studies have shown that NF-κB signaling pathway is in abnormal activation state in MZL. Bortezomib, a proteasome inhibitor targeting NF-κB pathway, has a promising therapeutic prospect in relapsed and refractory MZL. The goal of our trial is to assess 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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.

Other names: Bortezomib Injection

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.

Other names: RiTUXimab Injection

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.

Other names: Epirubicin hydrochloride

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.

Other names: Cyclophosphamide Injection

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

Other names: Prednisone Oral Product

Primary outcomes

  1. 2-year progression-free survival

    Time frame: 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

    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

  1. objective response rate

    Time frame: 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

    the total proportion of patients with complete response (CR) and partial response (PR)

  2. overall survival

    Time frame: 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

    from date of first day of treatment to the date of death by any cause

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

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

    the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03

Sponsors and collaborators

Lead sponsor

Henan Cancer Hospital

Other Gov

Registry information

Official study title

A Single Arm, Multi-center, Phase II Clinical Trial of VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jun 16, 2020
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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