UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000868 |
|---|---|
| Receipt number | 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 08:56:49 |
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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
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
radius@ims.u-tokyo.ac.jp
Sponsor or person
Institute
Research Grant on Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001043
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