Phase II study of R-CHOP and R-high-dose MTX therapy for IVLBC

Phase 2

• Conditions: Intravascular large B-cell lymphoma

• Registration Number: JPRN-jRCTs041180165
• Lead Sponsor: Yamaguchi Motoko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

1. Histologically diagnosed as intravascular large B-cell lymphoma
2. CD20-positive on immunohistochemistry and/or flowcytometry
3. Age between 20 and 79 year-old
4. ECOG performance status 0 to 3. PS 4 is eligible if improved PS 3 or better after corticosteroid monotherapy
5. No prior chemotherapy or monoclonal antibody therapy
6. Adequate organ functions including bone marrow, liver, kidney, cardiac and lung functions.
a) No active hepatitis or liver chirrhosis
b) Serum bilirubin less than 3mg/dl
c) Serum creatinine less than 2mg/dl
d) Left ventricular ejection fraction 50% or better
e) No ischemic heart disease requiring treatment, cardiomyopahty, heart failure and arrhythmia treated with anti-arrhythmics
f) SpO2 92% or better
g) WBC equal to or more than 3,000/ul, or ANC equal to or more than 1000/ul, and platelet equal to or more than 10 x 104/ul. Leukocytopenia or thrombocytopenia due to bone marrow invasion or hemophagocytic syndrome is permitted.
7. written informed consent

Exclusion Criteria

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