UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011234 |
|---|---|
| Receipt number | 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 10:04:06 |
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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
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
miyatay@nnh.hosp.go.jp
Public contact
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
miyatay@nnh.hosp.go.jp
Sponsor or person
Institute
Clinical Hematology Study Group of National Hospital Organization(CHSG-NHO)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012804
