UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of R-mini CHP for elderly patients with diffuse large B cell lymphoma
Title of the study (Brief title)	R-mini CHP
Region	Japan

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

Objectives
Narrative objectives1	The object of this clinical phase II study is to investigate efficacy and safety of R-mini CHP regimen in diffuse large B cell lymphoma patients who are more than 80 years old.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	2-year progression free survival
Key secondary outcomes	2-year over all survival, (complete) remission rate, safety, incidence of febrile neutropenia

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	Six cycles of R-miniCHP are scheduled as an induction therapy.
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	80 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.pathological diagnosis: diffuse large B cell lymphoma, NOS 2.CD20 antigen positive 3.CSI bulky, CSII/III/IV 4.presence of mesurable lesions 5.no prior therapy for lymphoma except pre-treatment with PSL 6.age: more than 80 years old 7.PS(ECOG): 0-2 (even after pre-treatment with PSL) 8.adequate organ funcitions 9.informed consented patients
Key exclusion criteria	1.presence of active infeciton 2.presence of central nervous invasion 3.past history of glaucoma. 4.past history of severe drug allergy. 5.HIV Ab positive or HTLV-1 Ab positive. 6.HBsAg positive or HCV Ab positive. 7.severe cardiac disease 8.hepatic cirrhosis 9.uncontrollable diabetis melitus 10.patients with dialysis 11.lung fibrosis or interstitial pneumonitis 12.other active malignancies 13.pregnant or feeding female 14.severe mental disorder 15.continuous systemic administration of steroid 16.judged for inappropriate with other reasons
Target sample size	40

Research contact person
Name of lead principal investigator	Yasuhiko Miyata
Organization	National Hospital Organization Nagoya Medical Center
Division name	Department of Hematology
Address	4-1-1, Sannomaru,Naka-Ku, Nagoya, Japan
TEL	052-951-1111
Email	miyatay@nnh.hosp.go.jp

Public contact
Name of contact person	Yasuhiko Miyata
Organization	National Hospital Organization Nagoya Medical Center
Division name	Department of Hematology
Address	4-1-1, Sannomaru,Naka-Ku, Nagoya, Japan
TEL	052-951-1111
Homepage URL
Email	miyatay@nnh.hosp.go.jp

Sponsor
Institute	Clinical Hematology Study Group of National Hospital Organization(CHSG-NHO)
Institute
Department

Funding Source
Organization	National Hospital Organization
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	H24-NHO(hematology)-01
Org. issuing International ID_1	National Hospital Organization
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立病院機構血液・造血器疾患政策医療ネットワーク(CHSG-NHO)参加施設

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 20 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 06 Month 18 Day
Anticipated trial start date	2013 Year 07 Month 22 Day
Last follow-up date	2018 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2013 Year 07 Month 19 Day
Last modified on	2017 Year 07 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012804