UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002743
Receipt number 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 10:57:24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

TOHOKU HEMATOLOGY FORUM

Institute

Department

Personal name



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

Value
https://center6.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