UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001050 |
|---|---|
| Receipt number | R000001258 |
| Scientific Title | A phase II study of the combination of Rituximab, Mitoxantrone, Etoposide, and Prednisolone for relapsed elderly patients with diffuse large B-cell lymphoma (R-MEP07) |
| Date of disclosure of the study information | 2008/03/01 |
| Last modified on | 2015/08/27 16:13:13 |
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Basic information
Public title
A phase II study of the combination of Rituximab, Mitoxantrone, Etoposide, and Prednisolone for relapsed elderly patients with diffuse large B-cell lymphoma (R-MEP07)
Acronym
A phase II study of the combination of Rituximab, Mitoxantrone, Etoposide, and Prednisolone for relapsed elderly patients with lymphoma (R-MEP07)
Scientific Title
A phase II study of the combination of Rituximab, Mitoxantrone, Etoposide, and Prednisolone for relapsed elderly patients with diffuse large B-cell lymphoma (R-MEP07)
Scientific Title:Acronym
A phase II study of the combination of Rituximab, Mitoxantrone, Etoposide, and Prednisolone for relapsed elderly patients with lymphoma (R-MEP07)
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 pricipal aims of the study are to investigate the efficacy and safety of the combination of rituximab, mitoxantrone, etoposide and prednisolone for relapsed elderly patients with diffuse large B-cell lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Overall tumor response
Key secondary outcomes
Complete response, three-year overall survival, three-year progression free survival, treatment related toxicity.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
R-MEP therapy: rituximab (375mg/m2) on day1 iv, mitoxantrone (6mg/m2) on day2 iv, etoposide (80mg/m2) on day2-6 po and prednisolone (40mg/m2) on day2-6 po. The R-MEP is repeated every 3 weeks for total four cycles.
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
| 70 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) PS (ECOG) 0-2
2) Diffuse large B-cell lymphoma (WHO classification).
Histologically/cytologically proven CD20 positive lymphoma
3) First relapse after prior chemotherapy. Interval of more than 24 weeks from the last chemotherapy
4) Having at least one measurable lesion
5) Well preserved major organ function
6) Cumulative doxorubicin doses <= 400mg/m2
7) Written informed consent
8) Expected survival of => 2 months
Key exclusion criteria
1) CNS involvement
2) History of glaucoma
3) History of severe drug allergy
4) Active infectious diseases
5) HIV or HTLV-1 positive
6) HBs antigen or HCV antibody positive
7) Significant complications which include cardiac dysfunction, liver cirrhosis, uncontrolled diabetes, renal failure
8) Interstitial pneumonitis or fibrosis
9) History of other active malignancy
10) Severe mental disorder
11) Regular use of systemic steroids
12) Inadequate physical condition, as diagnosed by primary physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuya Komeno |
Organization
National Hospital Organization Mito Medical Center
Division name
Department of Hematology
Zip code
Address
280 Sakuranosato, Ibaraki-machi, Ibaraki 311-3193 Japan
TEL
029-240-7711
t.komeno.d@mn.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Komeno |
Organization
National Hospital Organization Mito Medical center
Division name
Department of Hematology
Zip code
Address
280 Sakuranosato, Ibaraki-machi, Ibaraki 311-3193 Japan
TEL
029-240-7711
Homepage URL
t.komeno.d@mn.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
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 03 | Month | 01 | 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
Completed
Date of protocol fixation
| 2007 | Year | 11 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 02 | Month | 24 | Day |
Last modified on
| 2015 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001258
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