UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation for efficacy and safety of high dose chemotherapy (MEAM) supported with auto-PBSCT for malignant lymphoma (THF 13)
Title of the study (Brief title)	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	Kenichi Sawada
Organization	Akita University School of Medicine
Division name	Dept. of hematology
Address	1-1-1 Hondo, Akita, Akita, 010-8543 JAPAN
TEL
Email

Public contact
Name of contact person	Yoshihiro Kameoka
Organization	Akita University School of Medicine
Division name	Dept. of hematology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 09 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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