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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004147
Receipt No. R000004838
Scientific Title Single-arm confirmatory trial for the strategy including allogeneic hematopoietic stem cell transplantation for adult T-cell leukemia-lymphoma(JCOG0907, ATL-alloHSCT)
Date of disclosure of the study information 2010/09/02
Last modified on 2016/06/27

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Basic information
Public title Single-arm confirmatory trial for the strategy including allogeneic hematopoietic stem cell transplantation for adult T-cell leukemia-lymphoma(JCOG0907, ATL-alloHSCT)
Acronym Single-arm confirmatory trial for the strategy including allogeneic hematopoietic stem cell transplantation for adult T-cell leukemia-lymphoma(JCOG0907, ATL-alloHSCT)
Scientific Title Single-arm confirmatory trial for the strategy including allogeneic hematopoietic stem cell transplantation for adult T-cell leukemia-lymphoma(JCOG0907, ATL-alloHSCT)
Scientific Title:Acronym Single-arm confirmatory trial for the strategy including allogeneic hematopoietic stem cell transplantation for adult T-cell leukemia-lymphoma(JCOG0907, ATL-alloHSCT)
Region
Japan

Condition
Condition adult T-cell leukemia-lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of allogeneic hematopoietic stem cell transplantation for ATL
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Proportion of 3-year survival
Key secondary outcomes Overall survival, 3-year survival of subgroups, adverse events, treatment related mortality

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 strategy to intend to treat with allogeneic hematopoietic stem cell transplantation including both myeloablative and reduced intensity conditioning.
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) The proliferation of morphological abnormal lymphocytes and confirmation of T-cell with flowcytometry or immunostaining
2) Positive for ant HTLV-1 antibody
3) Acute type, lymphoma type or chronic type with poor prognostic factor (at least one of elevated level of BUN, elevated level of LDH and lower level of Alb)
4) Aged 20 to 65 years old
5) Preformance status 0-3
6) No prior chemotherapy or radiotherapy
7) No central nervus system involvement
8) Sufficient function of main organ
9) The will of receiving allogeneic hematopoietic stem cell transplantation
10) Written informed consent from patient
Key exclusion criteria 1) History of glaucome
2) Uncontrollable diabetes mellitus or administration of insulin
3) Uncontrollable hypertension
4) Poor cardiac function
5) Active infection requiring systemic therapy
6) Fever over 38 degrees centigrade
7) HBs antigen positive
8) HCV antibody positive
9) HIV antibody positive
10) Acute hepatitis or liver cirrhosis
11) Interistitial pneumonitis, pulmonary fibrosis or pulmonary emphysema
12) Synchronous or metachronous malignancy
13) History of malignant lymphoma or leukemia
14) Women during pregnancy or milk breast-feeding
15) Psychological problem
16) Radiation for bulky mass
17) Systemic steroid treatment
18) History of interferon-alpha administration
19) History of allergic reaction by antibody drugs except for gamma globulin
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunihiro Tsukasaki
Organization National Cancer Center Hospital East
Division name Department of Hematology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Email ktsukasa@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuya Fukushima
Organization JCOG0907 Coordinating Office
Division name Faculty of Medicine School of Health Sciences, University of the Ryukyus
Zip code
Address 207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa, 903-0215, Japan
TEL 098-895-1276
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Other
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 国立病院機構北海道がんセンター(北海道)
札幌北楡病院(北海道)
東北大学病院(宮城県)
秋田大学医学部(秋田県)
山形大学医学部(山形県)
群馬大学医学部附属病院(群馬県)
埼玉県立がんセンター(埼玉県)
埼玉医科大学総合医療センター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
国立がん研究センター中央病院(東京都)
杏林大学医学部(東京都)
東京慈恵会医科大学附属病院(東京都)
東京慈恵会医科大学第三病院(東京都)
順天堂大学医学部附属順天堂医院(東京都)
NTT東日本関東病院(東京都)
東海大学医学部(神奈川県)
金沢医科大学(石川県)
愛知県がんセンター中央病院(愛知県)
名古屋大学医学部(愛知県)
名古屋市立大学病院(愛知県)
名古屋第二赤十字病院(愛知県)
愛知医科大学附属病院(愛知県)
豊田厚生病院(愛知県)
三重大学医学部(三重県)
滋賀県立成人病センター(滋賀県)
京都府立医科大学(京都府)
兵庫県立がんセンター(兵庫県)
岡山医療センター(岡山県)
広島大学病院(広島県)
国立病院機構四国がんセンター(愛媛県)
愛媛大学医学部附属病院(愛媛県)
国立病院機構九州がんセンター(福岡県)
福岡大学医学部(福岡県)
国立病院機構九州医療センター(福岡県)
産業医科大学(福岡県)
佐賀大学医学部(佐賀県)
国立病院機構長崎医療センター(長崎県)
佐世保市立総合病院(長崎県)
長崎大学病院(長崎県)
日本赤十字社長崎原爆病院(長崎県)
熊本大学医学部(熊本県)
国立病院機構熊本医療センター(熊本県)
大分県立病院(大分県)
鹿児島大学医学部・歯学部附属病院(鹿児島県)
今村病院分院(鹿児島県)
琉球大学医学部附属病院(沖縄県)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 02 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 Open public recruiting
Date of protocol fixation
2010 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 02 Day
Last follow-up date
2022 Year 03 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 02 Day
Last modified on
2016 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004838

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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