UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000156 |
|---|---|
| Receipt number | R000000226 |
| Scientific Title | A phase II trial of targeted busulfan and cyclophosphamide conditioning for allogeneic hematopoietic stem cell transplantation for hematological malignancies |
| Date of disclosure of the study information | 2005/09/13 |
| Last modified on | 2014/05/12 08:25:09 |
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Basic information
Public title
A phase II trial of targeted busulfan and cyclophosphamide conditioning for allogeneic hematopoietic stem cell transplantation for hematological malignancies
Acronym
Targeted busulfan and cyclophosphamide for allogeneic hematopoietic stem cell transplantation (C-SHOT 0301)
Scientific Title
A phase II trial of targeted busulfan and cyclophosphamide conditioning for allogeneic hematopoietic stem cell transplantation for hematological malignancies
Scientific Title:Acronym
Targeted busulfan and cyclophosphamide for allogeneic hematopoietic stem cell transplantation (C-SHOT 0301)
Region
| Japan |
Condition
Condition
Chronic Myelogenous Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to investigate safety and efficacy of a combination of oral busulfan with AUC-targeted dose and cyclophosphamide for conditioning of allogeneic hematopoietic transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival at one year after transplantation
Key secondary outcomes
Disease-free survival, overall survival, pharmacokinetics of busulfan, incidence and severity of acute GVHD, incidence and severity of chronic GVHD, incidence and severity of hepatic veno-occlusive disease, mortality rate at 100 days after transplantaion, time to hematopoietic recovery, overall survival and disease-free survival in each disease group
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
Check plasma busulfan concentrations over time after the first administration, and calculate the optimal dose of busulfan to achieve optimal AUC from 7th to 16th administrations.
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Diagnosis of either MDS, AML or CML (except for blastic crisis)
(2) Age between 16 and 65 years old
(3) Available HLA-identical family donor, or HLA-identical or DRB1-mismatched unrelated donor
(4) First hematopoietic stem cell transplantation including auto transplant
(5) Performance status ranging from 0 to 2
(6)Written informed consent of participation
Key exclusion criteria
(1) Uncontrollable and active infection
(2) Positivity for HIV antibody and/or HBs antigen and/or HCV antibody
(3) Graft manipulation such as T cell depletion
(4) Impaired organ function (kidney; serum creatinine >2.0 mg/dl, Liver; aspartate aminotransferase more than 5 times high than upper limit or serum bilirubin >2.0mg/dl, heart; left ventricular ejection fraction less than 50%, lung; arterial oxygen saturation < 93% without oxygen inhalation.)
(5) History of drug allergy used in the present conditioning or GVHD prophylaxis.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Morishita |
Organization
JA Aichi Showa Hospital
Division name
Department of Hematology and Oncology
Zip code
Address
Nobaku 46, Nobaku-cho, Konan, Aichi, Japan
TEL
0587-56-4155
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akio Kohno |
Organization
JA Aichi Showa Hospital
Division name
Department of Hematology and Oncology
Zip code
Address
Nobaku 46, Nobaku-cho, Konan, Aichi, Japan
TEL
0587-56-4155
Homepage URL
http://www.c-shot.or.jp/study/
akohno@wd5.so-net.ne.jp
Sponsor or person
Institute
Nagoya Blood and Marrow Transplantation Group
Institute
Department
Personal name
Funding Source
Organization
Nagoya Blood and Marrow Transplantation Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Center for supporting hematology oncology trials
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
| 2005 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
http://www.c-shot.or.jp/study/
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/22631696
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
| 2003 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | 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
| 2005 | Year | 09 | Month | 10 | Day |
Last modified on
| 2014 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000226
