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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001050
Receipt No. 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

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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
Email 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
Email t.komeno.d@mn.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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001258

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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