UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057996 |
|---|---|
| Receipt number | R000066293 |
| Scientific Title | Spousal hematopoietic cell transplantation for post-transplant relapse/rejection: phase I/II study |
| Date of disclosure of the study information | 2025/05/29 |
| Last modified on | 2025/05/28 12:13:04 |
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Basic information
Public title
Spousal hematopoietic cell transplantation
Acronym
Spousal hematopoietic cell transplantation
Scientific Title
Spousal hematopoietic cell transplantation for post-transplant relapse/rejection: phase I/II study
Scientific Title:Acronym
Spousal hematopoietic cell transplantation for post-transplant relapse/rejection
Region
| Japan |
Condition
Condition
post-transplant relapse/rejection of hematologic malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of spousal hematopoietic cell transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Engraftment rate at day 30 after transplantation
Key secondary outcomes
Safety
Acute GVHD within 100 days post-transplantation.
Complications such as infections and thrombotic microangiopathy (TMA).
Other adverse events, evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE).
Non-relapse mortality.
Efficacy
5) One-year overall survival rate (the observation period ends one year after transplantation for the last enrolled patient).
6) Relapse rate.
7) Disease-free survival rate.
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
hematopoietic cell transplantation from sousal donor
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent spousal hematopoietic stem cell transplantation from the date of study approval up to March 31, 2030.
Key exclusion criteria
1) Serum creatine > 2.0 mg/dL
2) Serum total bilirubin > 2.0 mg/dL
3) Serum AST and/or ALT > 200 U/L
4) Ejection fraction < 45% on echocardiography
5) SpO2 <95% on room air
6) Performance status (ECOG score) of 3-4
However, cases in which these values are elevated due to the underlying disease and are expected to improve with treatment may not necessarily be excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ikegame |
Organization
Aichi Medical University
Division name
Hematopoietic cell transplantation center
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute City, Aichi 480-1195, Japan
TEL
+81-561-63-2086
kame@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ikegame |
Organization
Aichi Medical University
Division name
Hematopoietic cell transplantation center
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute City, Aichi 480-1195, Japan
TEL
+81-561-63-2086
Homepage URL
kame@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Aichi Medical University
Address
1-1 Yazakokarimata, Nagakute City, Aichi 480-1195, Japan
Tel
+81-561-62-3311
aichi-med@esct.bvits.com
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
| 2025 | Year | 05 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 28 | Day |
Last modified on
| 2025 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066293
