UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003648 |
|---|---|
| Receipt number | R000004409 |
| Scientific Title | A phase II study of allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using intravenous busulfan and cyclophosphamide as conditioning regimen. |
| Date of disclosure of the study information | 2010/06/15 |
| Last modified on | 2021/04/07 13:14:26 |
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Basic information
Public title
A phase II study of allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using intravenous busulfan and cyclophosphamide as conditioning regimen.
Acronym
KSGCT1002/C-SHOT1003
Scientific Title
A phase II study of allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using intravenous busulfan and cyclophosphamide as conditioning regimen.
Scientific Title:Acronym
KSGCT1002/C-SHOT1003
Region
| Japan |
Condition
Condition
CML(chronic myelogenous leukemia)
AML(acute myeloid leukemia)
MDS(myelodysplastic syndrome)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and efficacy of allogeneic hematopoietic stem cell transplantation using intravenous busulfan and cyclophosphamide as conditioning regimen for patients with CML, AML and MDS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Probability of event-free survival at 1 year after transplantation
Key secondary outcomes
(1) Incidence of Bearman's grade 2 or higher adverse events within 28 days after transplantation
(2) Cumulative incidence of engraftment at 100 days after transplantation
(3) Cumulative incidence of non-relapse mortality at 100 days after transplantation
(4) Cumulative incidence of SOS (sinusoidal obstruction syndrome) at 100 days after transplantation
(5) Cumulative incidence of Grade II-IV acute GVHD at 1 year after transplantation
(6) Cumulative incidence of chronic GVHD at 1 year after transplantation
(7) Probability of overall survival and cumulative incidence of relapse at 1 year after transplantation
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 |
Interventions/Control_1
Conditioning regimen
Intravenous busulfan 3.2mg/kg/day x 4days + cyclophosphamide 60mg/kg/day x 2days
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
| 55 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients between the age of 16 and 55 at informed consent
(2) Patients diagnosed as CML, AML, or MDS who are eligible for allogeneic hematopoietic stem cell transplantation. No limitation of disease status at transplantation. Patients who need chemotherapy for disease control except imatinib, dasatinib and nilotinib for CML are excluded.
(3) Patients who have the fixed schedule about the harvest of bone marrow or peripheral blood stem cells from related or unrelated donors who meet the following conditions:
1) HLA-A, B, DRB1 are genetically identical
2)HLA-A and B are genetically identical and 1 locus of HLA-DRB1 is genetically mismatched
(4) Patients whose performance status are 0 or 1 by ECOG criteria
(5) Patients who meet all of the following conditions:
1) SPO2>=94% by room air
2) sCr=<2.0mg/dL
3) T-bil=<1.5mg/dL
4) AST, ALT and r-GTP=<3 x upper limit of normal
5) Absence of abnormal findings of ECG which require therapeutic interventions
6) Ejection fraction of left ventricle>=50% by UCG
(6) Patients who give written informed consent following sufficient explanation. Patients who are under 20 years old are required to give informed consent from both persons with parental authority and patients themselves
Key exclusion criteria
(1) Patients with uncontrolled diabetes mellitus in spite of regular use of insulin
(2) Patients with uncontrolled hypertension in spite of use of antihypertensive drugs
(3) Patients who have active infection
(4) Patients who are positive for TPHA, HBV surface antigen, or anti-HCV antibody.
(5) Patients who are positive for anti-HTLV-I or anti-HIV antibody
(6) Patients who are not evaluated to be able to survive more than 100 days after transplantation
(7) Patients who have coinciding active malignancies
(8) Patients who are pregnant or in the lactation period
(9) Patients who have psychiatric disorder
(10) Patients who have prior hematopoietic stem cell transplantation
(11) Patients who are considered as inappropriate to register by attending physicians
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Okamoto, Miyamura Kouichi |
Organization
Kanto Study Group for Cell Therapy(KSGCT)
Nagoya Blood and Marrow Transplantation (NBMT) Group
Division name
Chairman
Zip code
Address
Tokyo, Aichi
TEL
03-6225-2040
ksgctdc@ksgct.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Yamashita, Sawa Masashi |
Organization
KSGCT, NBMTG
Division name
Study Coordinators
Zip code
Address
Tokyo
TEL
03-6225-2040
Homepage URL
tayamash@ncc.go.jp
Sponsor or person
Institute
Kanto Study Group for Cell Therapy
Nagoya Blood and Marrow Transplantation (NBMT) Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Center for Supporting Hematology-Oncology Trial(C-SHOT)
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
| 2010 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12185-020-02990-y
Number of participants that the trial has enrolled
40
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
| 2010 | Year | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 21 | Day |
Last modified on
| 2021 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004409
