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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011234
Receipt No. R000012804
Scientific Title Phase II study of R-mini CHP for elderly patients with diffuse large B cell lymphoma
Date of disclosure of the study information 2013/07/20
Last modified on 2017/07/22

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Basic information
Public title Phase II study of R-mini CHP for elderly patients with diffuse large B cell lymphoma
Acronym R-mini CHP
Scientific Title Phase II study of R-mini CHP for elderly patients with diffuse large B cell lymphoma
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Yasuhiko Miyata
Organization National Hospital Organization Nagoya Medical Center
Division name Department of Hematology
Zip code
Address 4-1-1, Sannomaru,Naka-Ku, Nagoya, Japan
TEL 052-951-1111
Email miyatay@nnh.hosp.go.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yasuhiko Miyata
Organization National Hospital Organization Nagoya Medical Center
Division name Department of Hematology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Enrolling by invitation
Date of protocol fixation
2013 Year 06 Month 18 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000012804

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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