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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000868
Receipt No. R000001043
Scientific Title Phase II study of cord blood transplantation using myeloablative conditioning in adult patiants (C-SHOT 0603)
Date of disclosure of the study information 2007/10/29
Last modified on 2011/09/14

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Basic information
Public title Phase II study of cord blood transplantation using myeloablative conditioning in adult patiants
(C-SHOT 0603)
Acronym Cord blood transplantation in adults
(C-SHOT 0603)
Scientific Title Phase II study of cord blood transplantation using myeloablative conditioning in adult patiants
(C-SHOT 0603)
Scientific Title:Acronym Cord blood transplantation in adults
(C-SHOT 0603)
Region
Japan

Condition
Condition Acute leukemia, Chronic myelogenous leukemia, Myelodysplastic syndrome
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To study effectiveness and safety of cord blood transplantation in adult patients with hematological malignancies using myeloablative conditioning regimen as same as the Institute of Medical Science, the University of Tokyo.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Event-free survival at one year after cord blood transplantation
Key secondary outcomes 1.Incidence and time of engraftment
2.Incidence and severity of acute GVHD
3.Incidence and severity of chronic GVHD
4.Disease-free survival and overall survival
5.Causes and incidence of sever toxicity
6.Incidence of relapse
7.Incidence of treatment-related toxicity (TRM)
8.Analysis of incidences of TRM between institutions

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 Conditioning regimen for cord blood transplant was twelve gray (Gy) total body irradiation (TBI), Cyclophosphamide (CPA) and high dose Ara-C with G-CSF for myeloid hematological malignant diseases, and 12 Gy TBI, CPA and high dose Ara-C for lymphoid hematological malignant diseases. Cyclosporine (10 hours continuous) and short-term Methotrexate (MTX; 15 mg/m2 Day 1, 10 mg/m2 Days 3, 6) are used for GVHD prophylaxis. Eligible single cord blood unit is infused without processing on the day of transplant (Day 0) after rapid thawing in 37 degree Celsius thermostat bath.
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
55 years-old >
Gender Male and Female
Key inclusion criteria A. Patients with diseases described as follows:
1. de novo AML except CR1
2. ALL in remission except CR1
3.High-risk acute leukemia in CR1 where high-risk is defined as evidence of t(9;22) or failed to achieve CR after several courses of induction chemo therapy
4. CML in second CP or more advanced
5. MDS in RAEB-1, RAEB-2 or RA with high-risk chromosomal abnormalities who require frequent transfusions
B. Patient who has no HLA-matched or one antigen-mismatched relatives
C. Patient who has adequate CB unit in CB banks in Japan
D. Age between 20 and 54 years
E. Performance states (ECOG)=0 or 1
F. No major organ dysfunctions described as follows:
1. SaO2; less than 95% in room air
2. Serum creatinine and total bilirubin; greater than 1.5 x normal value
3. AST and ALT; greater than 2 x normal value
4. Left ventricular ejection fraction; lower than 55%
G. Negative for anti-HLA antibody
H. Written informed consent to participate the trial
Key exclusion criteria 1.Active disease in central nerve system.
2.Uncontrollable diabetes
3.Uncontrollable hypertension
4.Active infection
5.Positive for TPHA or HBs antigen
6.Positive for HIV antibody
7.Malignancies addition to primary hematological malignant disease
8.Pregnant or during breast feeding
9.History of stem cell transplantation including autologous transplantation
10.Uncontrollable psycho-neurological symptoms
11.Physician's decision that it is not appropriate to register the patient to this study for other reasons
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shun-ichi Kato
Organization Tokai University, School of Medicine
Division name Research Center for regenerative
Zip code
Address 143 Shimokasuya,Isehara-city, Kanagawa
TEL 0463-93-1121
Email

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Takahashi
Organization The University of Tokyo Institute of Medical Science attachment hospital
Division name Internal Medicine
Zip code
Address 4-6-1 Shiroganedai,Minato-ku,Toukyou
TEL 03-3443-8111
Homepage URL
Email radius@ims.u-tokyo.ac.jp

Sponsor
Institute Research Grant on Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare
Institute
Department

Funding Source
Organization Research Grant on Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare
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
2007 Year 10 Month 29 Day

Related information
URL releasing protocol http://www.c-shot.or.jp/study/
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
2007 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
2010 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
2007 Year 10 Month 29 Day
Last modified on
2011 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001043

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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