A Phase II trial of DA-EPOCH And Rituximab with HD-MTX therapy for newly-diagnosed DLBCL with CD5 expression (PEARL5 study)

Conditions

CD5-positive diffuse large B-cell lymphoma

Kana Miyazaki, Rika Sakai, Noriko Iwaki, Go Yamamoto, Tomomi Yamada et al. (16 authors)

Journal of Clinical Oncology2021-05-20

10.1200/jco.2021.39.15_suppl.7551

DA-EPOCH-R combined with high-dose methotrexate in patients with newly diagnosed stage II-IV CD5-positive diffuse large B-cell lymphoma: a single-arm, open-label, phase II study

Kana Miyazaki, Naoko Asano, Tomomi Yamada, Kohta Miyawaki, Rika Sakai et al. (24 authors)

Haematologica2019-10-2444 citations

10.3324/haematol.2019.231076

Dose-adjusted (DA)-EPOCH-R with high-dose methotrexate (HD-MTX) for newly diagnosed stage II-IV CD5-positive diffuse large B-cell Iymphoma (CD5+ DLBCL): Primary analysis of PEARL5 study.

Kana Miyazaki, Naoko Asano, Tomomi Yamada, Kohta Miyawaki, Hirotaka Takasaki et al. (20 authors)

Journal of Clinical Oncology2018-05-201 citations

10.1200/jco.2018.36.15_suppl.7561

Dose-Adjusted (DA) - EPOCH-R with High-Dose Methotrexate for Newly Diagnosed CD5-Positive Diffuse Large B-Cell Lymphoma (CD5+ DLBCL): Interim Results from a Phase II Study

Kana Miyazaki, Naoko Asano, Tomomi Yamada, Hirotaka Takasaki, Tadahiko Igarashi et al. (20 authors)

Blood2016-12-021 citations

10.1182/blood.v128.22.3029.3029

Interventions

Four cycles of DA-EPOCH-R followed by 2 cycles of HD-MTX(3.5 g/m2 IV, day1, q2w) and additional 4 cycles of DA-EPOCH-R

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically confirmed CD5-positive diffuse large B-cell lymphoma according to the 2008 WHO classification (2) Confirmed CD20-positive and CD5-positive by immunohistochemistry and/or flow cytometry (3) Ann Arbor stage: II, III, or IV (4) Lymphoma cell count in peripheral blood 14 days before registration >= 10,000/mm3 (5) Age: 20 to 75 years old (6) PS (ECOG): 0-3 (7) No clinical symptoms of CNS involvement (8) Measureable lesion present (9) No prior chemotherapy, radiotherapy, and antibody therapy (10) Adequate organ function (11) Written informed consent

Exclusion criteria

Exclusion criteria: (1) History of angle-closure glaucoma (2) Uncontrollable diabetes mellitus in spite of insulin therapy (3) Uncontrollable hypertension (4) Pleural effusion or ascites except for those with little amount (5) Coronary artery disease under treatment; cardiomyopathy, heart failure, or arrhythmia treated with anti-arrhythmic (6) HBs antigen positive (7) HCV antibody positive (8) HIV antibody positive (9) Interstitial pneumonia, pulmonary fibrosis (10) Severe infection (11) Liver cirrhosis (12) Other active malignancies; history of lymphoma, myelodysplastic syndrome, or leukemia (13) Pregnant, possible pregnant, or breastfeeding woman (14) Severe psychosis (15) Under systemic corticosteroid therapy (16) Considered as ineligible by attending physicians for other reasons

Design outcomes

Primary

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

Secondary

Measure	Time frame
Complete response rate, overall response rate, overall survival, 2-year CNS recurrence rate, adverse events	—

Countries

Japan

Contacts

Public ContactKana Miyazaki

PEARL5 Coordinating Office Department of Hematology and Oncology, Mie University Graduate School of Medicine

k-myzk@clin.medic.mie-u.ac.jp059-232-1111

Outcome results

None listed