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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001672
Receipt No. 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

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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
Email

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
Email shigema@med.hokudai.ac.jp

Sponsor
Institute Department of Hematology and Oncology, Hokkaido University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002010

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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