UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004147
Receipt number 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 2021/01/06 13:40:11

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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 or person

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name



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

No longer recruiting

Date of protocol fixation

2010 Year 07 Month 26 Day

Date of IRB

2010 Year 09 Month 01 Day

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

2021 Year 01 Month 06 Day



Link to view the page

Value
https://center6.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