UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000359
Receipt number R000000457
Scientific Title Clinical phase II study of double-unit cord blood transplantation for hematological malignancies.(C-SHOT 0507)
Date of disclosure of the study information 2006/03/15
Last modified on 2013/04/17 14:15:05

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Basic information

Public title

Clinical phase II study of double-unit cord blood transplantation for hematological malignancies.(C-SHOT 0507)

Acronym

Double-unit cord blood transplantation(C-SHOT 0507)

Scientific Title

Clinical phase II study of double-unit cord blood transplantation for hematological malignancies.(C-SHOT 0507)

Scientific Title:Acronym

Double-unit cord blood transplantation(C-SHOT 0507)

Region

Japan


Condition

Condition

Hematological malignancies

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To study feasibility and effectiveness of double-unit cord blood transplantation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Event-free survival at one year after double-unit cord blood transplantation

Key secondary outcomes

Time of hematopoietic engraftment, treatment-related toxicity, incidence and severity of acute and chronic graft versus host disease, disease-free survival and overall survival at 1-year


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

To study feasibility and effectiveness of double-unit cord blood (CB) transplantation in patients with hematological malignancies requiring hematopoietic stem cell transplantation without any available single-unit CB.

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


Not applicable

Age-upper limit

55 years-old >

Gender

Male and Female

Key inclusion criteria

1) Patient with poor risk hematologic malignancies
2) Patient who receives double-unit CBT as first stem cell transplantation
3) Age: less than 55 years old
4) Patient without active infection at starting conditioning chemoradiatherapy
5) HIV-antibody negative patient
6) Patient who has no HLA-matched or one antigen-mismatched relatives
7) Patient who has no HLA-matched unrelated donor, or who requires urgent transplant even if he/she has HLA-matched unrelated donor
8) Patient who has no single CB unit with cell dose of more than 2.5x107/kg and 2 or more HLA antigen mismatches

Key exclusion criteria

1) ECOG's performance status; 2 or more
2) Ejection fraction(EF); less than 50%
3) SaO2; more than 93% in room air
4) Serum creatinine; 1.3mg/dl or greater
5) Total bilirubin; 1.6mg/dl or greater, or GOT; 2 x normal value or greater
6) Down's syndrome
7) Fanconi's anemia

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shun-ichi Kato, Shunro Kai

Organization

1) Tokai University, School of Medicine
2) Hyogo College of Medicine

Division name

1) Research Center for regenerative medicine 2) The Department of Transfusion Medicine

Zip code


Address

1) Boseidai, Isehara-city, Kanagawa 2) 1-1,Mukogawa-cho,Nishinomiya,Hyogo

TEL

0463-93-1121

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shiro Yoshiba

Organization

Registry office of double-unit cord blood transplantation

Division name

Research Center for regenerative medicine

Zip code


Address

Boseidai, Isehara-city, Kanagawa

TEL

0463-93-1121

Homepage URL


Email



Sponsor or person

Institute

A Research Grant on Human Genome, Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare: Research on advancement and safety security of HSCT using umbilical cord blood.

Institute

Department

Personal name



Funding Source

Organization

A Research Grant on Human Genome, Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare: Research on advancement and safety security of HSCT using umbilical cord blood.

Organization

Division

Category of Funding Organization

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



Other administrative information

Date of disclosure of the study information

2006 Year 03 Month 15 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

Completed

Date of protocol fixation

2006 Year 03 Month 02 Day

Date of IRB


Anticipated trial start date

2006 Year 03 Month 01 Day

Last follow-up date

2010 Year 03 Month 01 Day

Date of closure to data entry

2010 Year 09 Month 01 Day

Date trial data considered complete

2011 Year 03 Month 01 Day

Date analysis concluded

2011 Year 07 Month 01 Day


Other

Other related information



Management information

Registered date

2006 Year 03 Month 15 Day

Last modified on

2013 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000457


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name