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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000156
Receipt No. 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

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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
Email

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/
Email akohno@wd5.so-net.ne.jp

Sponsor
Institute Nagoya Blood and Marrow Transplantation Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000226

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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