UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001672 |
|---|---|
| Receipt number | R000002010 |
| Scientific Title | A prospective clinical phase II study of allogeneic stem cell transplantation using conditioning regimen with medium-dose VP-16, cyclophosphamide and total-body irradiation for patients with acute lymphoblastic leukemia. |
| Date of disclosure of the study information | 2009/01/31 |
| Last modified on | 2011/09/14 09:46:03 |
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Basic information
Public title
A prospective clinical phase II study of allogeneic stem cell transplantation using conditioning regimen with medium-dose VP-16, cyclophosphamide and total-body irradiation for patients with acute lymphoblastic leukemia.
Acronym
Allo-SCT using conditioning with medium-dose VP/CY/TBI for ALL (C-SHOT 0901)
Scientific Title
A prospective clinical phase II study of allogeneic stem cell transplantation using conditioning regimen with medium-dose VP-16, cyclophosphamide and total-body irradiation for patients with acute lymphoblastic leukemia.
Scientific Title:Acronym
Allo-SCT using conditioning with medium-dose VP/CY/TBI for ALL (C-SHOT 0901)
Region
| Japan |
Condition
Condition
Acute lymphoblastic leukeimia
Acute biphenotypic leukemia
(Acute leukemias of ambiguous lineage )
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the efficacy of a combination of medium-dose VP-16, cyclophosphamide and total body irradiation as a conditioning regimen of allogeneic stem cell transplantation for acute lymphoblastic leukemia or acute biphenotypic leukemia.
Basic objectives2
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 transplantation
(event: relapse or death)
Key secondary outcomes
Overall survival at one year and at two year after transplantation
Event-free survival at one year after transplantation
Non-relapse mortality at 100 days and at one year after transplantation
Regimen-related toxicity
Relapse rate at 100 days and at one year after transplantation
Engraftment rate of neutrophil and platelet
Incidence and severity of acute GVHD
incidence and severity of chronic GVHD
Incidence of infection
Incidence of late complication and secondary malignancy
Subclass analysis; donor, stem cell, age, Ph chromosome, disease status at transplantation, risk factors for ALL
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
Allogeneic stem cell transplantation for patients with acute lymphoblastic leukemia or acute biphenotypic leukemia following conditioning regimen of medium-dose VP, CY and TBI. This regimen consists of VP-16 (etoposide) at a dose of 15 mg/kg once daily on days -7 and -6 (total dose: 30 mg/kg) and CY at 60 mg/kg once daily on days -5 and -4 (total dose: 120 mg/kg) combined with fractionated TBI (total dose: 12 Gy).
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
| 15 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Diagnosis of either acute lymphoblastic leukemia or acute biphenotypic leukemia
2. Age between 15 and 50 years old
3. In complete remission
4. First stem cell transplantation
5. ECOG performance status 0-2
6. Intact organ function
7. Applicable stem cell
(HLA-matched bone marrow or HLA-matched peripheral blood stem cell)
8. Written informed consent of participation
Key exclusion criteria
1.ALL L3 (Burkitt leukemia)
2. Positivity for HBs antigen and/or HCV antibody and/or HIV antibody
3. Double cancers
4. Infection that need to be treated
5. Severe mental disorder
6. Pregnant or breast-feeding woman
7. Uncontrolled diabetes mellitus even by insulin treatment
8. Myocardial infarction or heart failure
9. Liver cirrhosis
10. Body mass index more than 35
11. Severe arrhythmia
12. Having pentostatin
13. Severe allergy for VP-16 or cyclophosphamide
14.An inappropriate patient judged by the medical attendant
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Imamura |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Hematology and Oncology
Zip code
Address
Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akio Shigematsu |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Hematology and Oncology
Zip code
Address
Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-7214
Homepage URL
shigema@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Hematology and Oncology, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Grant-in-Aid for Cancer Research (19-1) from Ministry of Health, Labor and Welfare of Japan.
Organization
Division
Category of Funding Organization
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
| 2009 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
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
| 2009 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | 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
| 2009 | Year | 01 | Month | 30 | 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=R000002010
