Back to resultsVR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma
Primary Purpose
Marginal Zone Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Bortezomib
Rituximab
Epirubicin
Cyclophosphamide
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Marginal Zone Lymphoma focused on measuring Marginal Zone Lymphoma, VR-CAP
Eligibility Criteria
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
Sites / Locations
- Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou universityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VR-CAP
Arm 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
objective response rate
the total proportion of patients with complete response (CR) and partial response (PR)
overall survival
from date of first day of treatment to the date of death by any cause
incidence and relationship with study drugs of grade 3-4 adverse events
the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04433156
Brief Title
VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma
Official Title
A Single Arm, Multi-center, Phase II Clinical Trial of VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 22, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marginal Zone Lymphoma
Keywords
Marginal Zone Lymphoma, VR-CAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VR-CAP
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Bortezomib Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
RiTUXimab Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Other Intervention Name(s)
Epirubicin hydrochloride
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cyclophosphamide Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Prednisone Oral Product
Intervention Description
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
Primary Outcome Measure Information:
Title
2-year progression-free survival
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
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
Secondary Outcome Measure Information:
Title
objective response rate
Description
the total proportion of patients with complete response (CR) and partial response (PR)
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
Title
overall survival
Description
from date of first day of treatment to the date of death by any cause
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
Title
incidence and relationship with study drugs of grade 3-4 adverse events
Description
the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanyan Liu, M.D. Ph.D
Phone
+8613818176375
Email
yyliu@zzu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanyan Liu, M.D. Ph.D
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanyan Liu, M.D. Ph.D
Phone
+8613818176375
Email
yyliu@zzu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yanyan Liu, M.D. Ph.D
12. IPD Sharing Statement
Plan to Share IPD
No
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VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma
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