Marginal Zone Lymphoma
Conditions
Keywords
Marginal Zone Lymphoma, VR-CAP
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.
Interventions
DRUGBortezomib
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.
DRUGRituximab
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.
DRUGEpirubicin
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.
DRUGCyclophosphamide
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.
DRUGPrednisone
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
Sponsors
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year progression-free survival | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | the total proportion of patients with complete response (CR) and partial response (PR) |
| 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 | 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 | 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 |
Countries
China
Contacts
STUDY_DIRECTORYanyan Liu, M.D. Ph.D
Henan Cancer Hospital
Outcome results
None listed