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

JRCT ID: jRCTs041180165

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Intravascular large B-cell lymphoma
• Date of first enrollment: 29/03/2019
• Target sample size: 37
• Study type: Interventional
• Intervention(s): Three cycles of R-CHOP followed by 2 cycles of R-HDMTX and 3 additional cycles of R-CHOP. Four doses of IT is administered during R-CHOP phase.

Outcome(s)

• Primary Outcome: 2-year progression-free survival rate
• Secondary Outcome: complete response rate; %CR, 2-year overall survival rate; 2-year OS, 2-year CNS recurrence rate, adverse event, patterns of disease progression

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yamaguchi Motoko
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Mie University Hospital
• Secondary ID(s): UMIN000005707