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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002743
Receipt No. R000003335
Scientific Title Investigation for efficacy and safety of high dose chemotherapy (MEAM) supported with auto-PBSCT for malignant lymphoma (THF 13)
Date of disclosure of the study information 2009/11/10
Last modified on 2019/01/28

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Basic information
Public title Investigation for efficacy and safety of high dose chemotherapy (MEAM) supported with auto-PBSCT for malignant lymphoma (THF 13)
Acronym MEAM-auto-PBSCT-ML (THF 13)
Scientific Title Investigation for efficacy and safety of high dose chemotherapy (MEAM) supported with auto-PBSCT for malignant lymphoma (THF 13)
Scientific Title:Acronym MEAM-auto-PBSCT-ML (THF 13)
Region
Japan

Condition
Condition Malignant lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy and safety of MEAM high dose chemotherapy with auto-PBSCT for malignant lymphoma.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Incidence of adverse events, incidnece of therapy related mortality
Key secondary outcomes

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 Investigation for efficacy and safety of high dose chemotherapy (MEAM) supported with auto-PBSCT for malignant lymphoma.
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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1. pathohistological diagnosed for malignant lymphoma
2. indication for high dose chemotherapy (MEAM) with auto-PBSCT
3. CD34+cell>2x106/kg are available
4 patients approved by written informed consent
5 age:20-65
6 performance status of 0-2
7 no major organ dysfunction
8 no cardiac abnormality to need treatment
9 ejection fraction >50%
Key exclusion criteria 1 severe bacterial infection
2 positive test for HIV antibody
3 positive test for HBs antigen
4 positive test for HCV antibody
5 angina pectoris, myocardial infarction, treatment required arrhythmia
6 interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Sawada
Organization Akita University School of Medicine
Division name Dept. of hematology
Zip code
Address 1-1-1 Hondo, Akita, Akita, 010-8543 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Kameoka
Organization Akita University School of Medicine
Division name Dept. of hematology
Zip code
Address 1-1-1 Hondo, Akita, Akita, 010-8543 JAPAN
TEL
Homepage URL
Email

Sponsor
Institute TOHOKU HEMATOLOGY FORUM
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 THF 13
Org. issuing International ID_1 TOHOKU HEMATOLOGY FORUM
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

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
2009 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2015 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 10 Day
Last modified on
2019 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003335

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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