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

Marginal Zone Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04433156
• Other study ID #: HNSZLYYNHL03
• Status: Recruiting
• Phase: Phase 2
• Start date: April 22, 2020
• Est. completion date: April 22, 2025

Study information

• Verified date: May 2023
• Source: Henan Cancer Hospital
• Contact: Yanyan Liu, M.D. Ph.D
• Phone: +8613818176375
• Email: yyliu[@]zzu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 22, 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Marginal Zone Lymphoma

Intervention

Drug:
• Bortezomib
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.
• Rituximab
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.
• Epirubicin
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.
• Cyclophosphamide
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.
• Prednisone
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

Locations

Country	Name	City	State
China	Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	objective response rate	the total proportion of patients with complete response (CR) and partial response (PR)	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
Secondary	overall survival	from date of first day of treatment to the date of death by any cause	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
Secondary	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	from the beginning day of the first cycle (each cycle is 21 days) of treatment to 6 months after last patient's enrollment