UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037581 |
|---|---|
| Receipt number | R000042842 |
| Scientific Title | Phase I trial of Total Marrow and Lymphoid Irradiation Transplantation Conditioning |
| Date of disclosure of the study information | 2019/08/02 |
| Last modified on | 2023/06/08 11:52:00 |
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Basic information
Public title
Phase I trial of Total Marrow and Lymphoid Irradiation Transplantation Conditioning
Acronym
Phase I trial of Total Marrow and Lymphoid Irradiation Transplantation Conditioning
Scientific Title
Phase I trial of Total Marrow and Lymphoid Irradiation Transplantation Conditioning
Scientific Title:Acronym
Phase I trial of Total Marrow and Lymphoid Irradiation Transplantation Conditioning
Region
| Japan |
Condition
Condition
Hematologic malignancy
Classification by specialty
| Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objectives were to establish the maximum tolerated dose of TMLI and to describe the toxicities at each dose level.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dose limited toxicities until 100 days after irradiation.
Key secondary outcomes
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
| Other |
Interventions/Control_1
TMLI 14-18Gy/6fr
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with hematologic malignancy who are planned HSCT using myeloablative conditioning regimen.
2. Age between 20 and 60.
3. PS 0-2
4. Major organ function is maintained
5. Written informed consent
Key exclusion criteria
1. with active extramedullary lesion
2. disease status is non-CR
3. with active another malignant disease
4. Restlessness
5. with pregnant or possible pregnant
6. with once or more HSCT history
7. Serious medical or psychological problems
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Karasawa |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Radiation Oncology
Zip code
1138677
Address
3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL
03-3823-2101
karasawa@cick.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ogawa |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Radiation Oncology
Zip code
1138677
Address
3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL
03-3823-2101
Homepage URL
hogawa@cick.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Address
3-18-22 Honkomagome, Bunkyo-ku,Tokyo
Tel
03-3823-2101
rinri@cick.jp
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
| 2019 | Year | 08 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
9
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
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 01 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 02 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042842
