UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032819 |
|---|---|
| Receipt number | R000037403 |
| Scientific Title | Phase I clinical trial with umbilical cord-derived mesenchymal stromal cells (IMSUT-CORD) for treatment-resistant severe acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2021/06/01 14:27:13 |
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Basic information
Public title
Phase I clinical trial with umbilical cord-derived mesenchymal stromal cells (IMSUT-CORD) for treatment-resistant severe acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation
Acronym
Phase I clinical trial with umbilical cord-derived mesenchymal stromal cells (IMSUT-CORD) for treatment-resistant severe acute graft-versus-host disease (GVHD)
Scientific Title
Phase I clinical trial with umbilical cord-derived mesenchymal stromal cells (IMSUT-CORD) for treatment-resistant severe acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym
Phase I clinical trial with umbilical cord-derived mesenchymal stromal cells (IMSUT-CORD) for treatment-resistant severe acute graft-versus-host disease (GVHD)
Region
| Japan |
Condition
Condition
First line treatment-resistant Grade II to IV acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to evaluate the safety and exploratory efficacy of umbilical cord-derived mesenchymal stromal cells (IMSUT-CORD) for patients with first line treatment-resistant grade II to IV severe acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safety:
1) Incidence of Dose Limited Toxicity (DLI) and determination of optical dose for phase II studies.
2) Evaluation of adverse events such as the rate of events, until 11 weeks after the last administration of IMSUT-CORD.
3) Statistical evaluation of laboratory tests until 11 weeks after the last administration of IMSUT-CORD.
Key secondary outcomes
Efficacy:
1) Overall response and change of stage/grading of organ damages by acute GVHD at 11 weeks after the last administration of IMSUT-CORD
2) Overall survival (OS)
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
Intravenous of IMSUT-CORD with dose escalation by 3+3 design
Cohort 1 dose:1x10^6cells /kg,
Cohort 2 dose:2x10^6 cells /kg,
Cohort -1 dose:5x10^5 cells /kg
After safety confirmation at cohort 1, proceed to cohort 2. If two patients reveal DLT in at cohort 1, cohort -1 will be tested.
One cycle is defined as twice a week administration, and standard treatment is 2 cycles of administration. Up to two cycles of administration (total four cycles) is allowed for patients with no significant adverse effects and Partial response (PR) or Mixed response (MR).
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria:
1. Patients with grade II to IV acute GVHD. Pathological diagnosis is required, if possible.
2. Patients resistant to standard therapy with glucocorticoid.
3. Patients Aged 20 to 70 years at the time of consent
4. Patients who can give their consent by the written form.
Key exclusion criteria
Exclusion criteria:
1. Patients NOT treated with standard first-line treatment with glucocorticoid for acute GVHD (except for prevention therapy for acute GVHD).
2. Patients treated with hematopoietic stem cell transplantation for hematopoietic malignancies under no remission, except for myelodysplastic syndrome with or without leukemic transition and myeloproliferative diseases.
3. Patients with following severe complications within 14 days before registration.
a) Cardiac function: Ejection fraction <40%
b) Pulmonary function: SpO2 < 90% or SpO2 < 95% under oxygen inhalation.
c) Renal function: serum creatinine -> 2 times of upper limit of institutional normal range (ULN).
d) Liver function:
serum total bilirubin ->3 times of ULN, AST/ALT -> 5 times of ULN.
4. Pregnant/possible pregnant and nursing woman. Patients refuse to contraception.
5. Patients positive for HIV antibodies, HTLV-I antibodies, HBs antigen, and HCV antibodies.
6. Therapy resistant hypertension
7. Patient who have allergy against reagents used for processing, such as amphotericin B, gentamicin. Patients treated as emergency for adverse reaction of DMSO.
8.Investigators decision as not eligible.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Arinobu Tojo |
Organization
The Institute of Medical Science, The University of Tokyo
Division name
Department of Hematology/Oncology, IMSUT Hospital
Zip code
Address
4-6-1, Shirokanedai, Minato-ku, Tokyo
TEL
03-3443-8111
dctsm@ims.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Center for Translational Research |
Organization
The Institute of Medical Science, The University of Tokyo
Division name
Center for Translational Research
Zip code
Address
4-6-1, Shirokanedai, Minato-ku, Tokyo
TEL
03-5449-5462
Homepage URL
dctsm@ims.u-tokyo.ac.jp
Sponsor or person
Institute
The Institute of Medical Science, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
東京大学医科学研究所附属病院(東京都)
国家公務員共済組合連合会虎の門病院（東京都）
がん・感染症センター都立駒込病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 09 | Month | 11 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 31 | Day |
Last modified on
| 2021 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037403
