UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II trial of Dose adjusted EPOCH and Rituximab therapy for newly-diagnosed DLBCL with C-MYC rearrangement
Title of the study (Brief title)	A Phase II trial of DA-EPOCH-R therapy for newly-diagnosed DLBCL with C-MYC rearrangement
Region	Japan

Condition
Condition	C-MYC positive diffuse large B-cell lymphoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Phase II trial to evaluate efficacy and toxicity of DA-EPOCH-R combined therapy for patients with newly-diagnosed C-MYC positive diffuse large B-cell lymphoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	2-year progression-free survival rate
Key secondary outcomes	Overall response rate, Complete response rate, Overall survival, Toxicity

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	DA-EPOCH-R
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Histologically confirmed DLBCL, NOS according to the 2008 WHO classification (2) Confirmed CD20-positive (3) Confirmed C-MYC-positive by FISH (4) Tumor cell counts in the peripheral blood within 14 days before resistration are less than 10,000/mm3 (5) Age: 20 to 75 years old (6) PS (ECOG): 0-2 (7) No clinical symptoms of CNS involvement (8) Measureable lesion present (9) No prior chemotherapy, radiotherapy, and antibody therapy for DLBCL (10) Adequate organ function (11) Written informed consent
Key exclusion criteria	(1) History of glaucoma (2) Uncontrollable diabetes mellitus (3) Uncontrollable hypertension (4) Coronary artery disease under treatment; cardiomyopathy, heart failure, or arrhythmia treated with anti-arrhythmic (5) HBs antigen positive (6) HCV antibody positive (7) HIV antibody positive (8) Interstitial pneumonia, pulmonary fibrosis (9) Severe infection (10) Liver cirrhosis (11) Other active malignancies; history of lymphoma, myelodysplastic syndrome, or leukemia (12) Pregnant, possible pregnant, or breastfeeding woman (13) Severe psychosis (14) Under systemic corticosteroid therapy
Target sample size	34

Research contact person
Name of lead principal investigator	Naoya Nakamura, M.D., Ph.D.
Organization	Tokai University School of Medicine
Division name	Department of Pathology
Address	143 Shimokasuya, Isehara, Kanagawa 259-1143, Japan
TEL	0463-93-1121
Email	naoya@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	Minoru Kojima, M.D., Ph.D.
Organization	Tokai University School of Medicine
Division name	Division of Hematology/Oncology
Address	143 Shimokasuya, Isehara, Kanagawa 259-1143, Japan
TEL	0463-93-1121
Homepage URL
Email	kojima@tokai-u.jp

Sponsor
Institute	Kanagawa Clinical Oncology study Group
Institute
Department

Funding Source
Organization	Tokai University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Tokai University School of Medicine

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東海大学医学部付属病院（神奈川県） 聖マリアンナ医科大学（神奈川県） 神奈川県立がんセンター（神奈川県） 北里大学（神奈川県） 横浜市立大学附属市民総合医療センター（神奈川県） 横浜市立大学附属病院（神奈川県） 東京都健康長寿医療センター（東京都） 川崎市立多摩病院（神奈川県） 海老名総合病院（神奈川県） 秦野赤十字病院（神奈川県） 小澤病院（神奈川県） 横浜市立市民病院（神奈川県） 東京医科大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 28 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date	2017 Year 04 Month 30 Day
Date of closure to data entry	2017 Year 04 Month 30 Day
Date trial data considered complete	2017 Year 04 Month 30 Day
Date analysis concluded	2017 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 16 Day
Last modified on	2017 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018576