UMIN-CTR Clinical Trial

Basic information
Public title	A Phase II trial of DA-EPOCH And Rituximab with HD-MTX therapy for newly-diagnosed DLBCL with CD5 expression (PEARL5 study)
Acronym	A Phase II trial of DA-EPOCH And Rituximab with HD-MTX therapy for newly-diagnosed DLBCL with CD5 expression (PEARL5 study)
Scientific Title	A Phase II trial of DA-EPOCH And Rituximab with HD-MTX therapy for newly-diagnosed DLBCL with CD5 expression (PEARL5 study)
Scientific Title:Acronym	A Phase II trial of DA-EPOCH And Rituximab with HD-MTX therapy for newly-diagnosed DLBCL with CD5 expression (PEARL5 study)
Region	Japan

Condition
Condition	CD5-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 with high-dose (HD) MTX therapy for patients with newly-diagnosed, stage II-IV CD5-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	Complete response rate, overall response rate, overall survival, 2-year CNS recurrence rate, adverse events

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	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
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 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
Key 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
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Motoko Middle name Last name Yamaguchi
Organization	Mie University Graduate School of Medicine
Division name	Department of Hematology and Oncology
Zip code	514-8507
Address	2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL	059-231-5418
Email	waniwani@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	1st name Kana Middle name Last name Miyazaki
Organization	PEARL5 Coordinating Office
Division name	Department of Hematology and Oncology, Mie University Graduate School of Medicine
Zip code	514-8507
Address	2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL	059-232-1111
Homepage URL
Email	k-myzk@clin.medic.mie-u.ac.jp

Sponsor
Institute	CD5+ DLBCL Treatment Study Group
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development, AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)	Department of Hematology and Oncology, Mie University Graduate School of Medicine

IRB Contact (For public release)
Organization	institutional review board, Mie University School of Medicine
Address	2-174 Edobashi, Tsu, Mie 514-8507, Japan
Tel	059-232-1111
Email	s-kikaku2@mo.medic.mie-u.ac.jp

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	東北大学病院（宮城県） 筑波大学病院（茨城県） 群馬県立がんセンター（群馬県） 公立藤岡総合病院（群馬県） 埼玉医科大学国際医療センター（埼玉県） 虎の門病院（東京都） 国立病院機構東京医療センター（東京都） 虎の門病院分院（神奈川県） 横浜市立大学（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） 金沢医科大学（石川県） 金沢大学医学部（石川県） 恵寿金沢病院（石川県） 福井県済生会病院（福井県） 藤田医科大学（愛知県） 愛知厚生連海南病院（愛知県） 三重大学医学部（三重県） 京都大学医学部（京都府） 神鋼記念病院（兵庫県） 島根大学医学部附属病院（島根県） 国立病院機構岡山医療センター（岡山県） 国立病院機構四国がんセンター（愛媛県） 国立病院機構九州がんセンター（福岡県）

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 25 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	47
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 06 Month 28 Day
Date of IRB	2012 Year 07 Month 06 Day
Anticipated trial start date	2012 Year 07 Month 25 Day
Last follow-up date	2020 Year 11 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 07 Month 23 Day
Last modified on	2021 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009998