Phase II study of R-CHOP and R-high-dose MTX therapy for IVLBCL (PRIMEUR-IVL)
- Conditions
- Intravascular large B-cell lymphoma
- Registration Number
- JPRN-UMIN000005707
- Lead Sponsor
- IVL study group in Japan
- Brief Summary
With a median follow-up of 3.9 years (IQR 2.5 to 5.5), 2-year progression-free survival was 76% (95% CI 58 to 87). 2-year overall survival was 92% (95% CI 77 to 97). The cumulative incidence of secondary CNS recurrence at 2 years was 3% (95% CI 0.2 to 12).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 38
Not provided
1. De novo DLBCL 2. CNS involvement on CT and/or MRI, or CSF examination 3. Glaucoma requiring treatment 4. Diabetes mellitus requiring insulin treatment 5. Hypertension 6. Positive on HBsAg. HBV-DNA positive if HBsAb and/or HBcAb are positive 7. Positive on HCV Ab 8. Positive on HIV Ab 9. Interstitial pneumonitis, pulmonary fibrosis, and sever pulmonary emphysema 10. Sever infection 11. Active cancers 12. Past history of leukemia, lymphoma and myelodysplastic syndrome 13. Having treatment with major tranquilizer, antidepressant, and antimanic 14. Psychiatric diseases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-year progression free survival rate; 2-year PFS
- Secondary Outcome Measures
Name Time Method complete response rate; %CR, 2-year overall survival rate; 2-year OS, 2-year CNS recurrence rate, adverse event, patterns of disease progression