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

STATUS

Recruiting
participants needed

60
sponsor

Henan Cancer Hospital

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Updated on 19 February 2024

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cyclophosphamide

prednisone

rituximab

lymphoma

bortezomib

epirubicin

marginal zone lymphoma

malt

Summary

This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of VR-CAP (Velcade 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-B signaling pathway is in abnormal activation state in MZL. Velcade(Bortezomib), a proteasome inhibitor targeting NF-B 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 (Velcade and Rituximab-Cyclophosphamide, Epirubicin and Prednisone) in the first-line treatment for patients with marginal zone lymphoma.

Details

Condition	MALT Lymphoma, marginal zone lymphoma, marginal zone lymphoma
Age	18years - 70years
Treatment	Cyclophosphamide, Rituximab, Epirubicin, Prednisone, Velcade
Clinical Study Identifier	NCT04433156
Sponsor	Henan Cancer Hospital
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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
	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 hepatitisHBV/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

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