Phase II study of R-CHOP and R-high-dose MTX therapy for IVLBCL (PRIMEUR-IVL)

Conditions

Intravascular large B-cell lymphoma

Shimada K, Yamaguchi M, Kuwatsuka Y, Matsue K, Sato K, Kusumoto S, Nagai H, Takizawa J, Fukuhara N, Nagafuji K, Miyazaki K, Ohtsuka E, Okamoto A, Sugita Y, Uchida T, Kayukawa S, Wake A, Ennishi D, Kondo Y, Meguro A, Kin Y, Minami Y, Hashimoto D, Nishiyama T, Shimada S, Masaki Y, Okamoto M, Atsuta Y, Kiyoi H, Suzuki R, Nakamura S, Kinoshita T.

2025-01-316 citations

10.1016/j.eclinm.2025.103078

Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone combined with high-dose methotrexate plus intrathecal chemotherapy for newly diagnosed intravascular large B-cell lymphoma (PRIMEUR-IVL): a multicentre, single-arm, phase 2 trial.

Shimada K, Yamaguchi M, Atsuta Y, Matsue K, Sato K, Kusumoto S, Nagai H, Takizawa J, Fukuhara N, Nagafuji K, Miyazaki K, Ohtsuka E, Okamoto M, Sugita Y, Uchida T, Kayukawa S, Wake A, Ennishi D, Kondo Y, Izumi T, Kin Y, Tsukasaki K, Hashimoto D, Yuge M, Yanagisawa A, Kuwatsuka Y, Shimada S, Masaki Y, Niitsu N, Kiyoi H, Suzuki R, Tokunaga T, Nakamura S, Kinoshita T.

2020-03-1173 citations

10.1016/s1470-2045(20)30059-0

Favorable Outcomes of Newly Diagnosed Intravascular Large B-Cell Lymphoma Patients Treated with R-CHOP Combined with High-Dose Methotrexate Plus Intrathecal Chemotherapy: Results from a Multicenter Phase 2 Trial (PRIMEUR-IVL)

Kazuyuki Shimada, Motoko Yamaguchi, Yoshiko Atsuta, Kosei Matsue, Keijiro Sato et al. (34 authors)

Blood2019-11-132 citations

10.1182/blood-2019-126798

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
2-year progression free survival rate; 2-year PFS	—

Secondary

Measure	Time frame
complete response rate; %CR, 2-year overall survival rate; 2-year OS, 2-year CNS recurrence rate, adverse event, patterns of disease progression	—

Countries

Japan

Contacts

Public ContactKazuyuki Shimada

Nagoya University Graduate School of Medicine Department of Hematology and Oncology

kshimada@med.nagoya-u.ac.jp052-744-2145

Outcome results

None listed