UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043766 |
|---|---|
| Receipt number | R000049962 |
| Scientific Title | Consolidative donor lymphocyte infusion following HLA-mismatched allogeneic hematopoietic stem cell transplantation from haploidentical donor for hematological malignancy in non-remission. |
| Date of disclosure of the study information | 2021/03/30 |
| Last modified on | 2023/10/12 16:58:16 |
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Basic information
Public title
Consolidative donor lymphocyte infusion following HLA-mismatched allogeneic hematopoietic stem cell transplantation from haploidentical donor for hematological malignancy in non-remission.
Acronym
Consolidative DLI following haploidentical HSCT for hematological malignancy in non-CR.
Scientific Title
Consolidative donor lymphocyte infusion following HLA-mismatched allogeneic hematopoietic stem cell transplantation from haploidentical donor for hematological malignancy in non-remission.
Scientific Title:Acronym
Consolidative DLI following haploidentical HSCT for hematological malignancy in non-CR.
Region
| Japan |
Condition
Condition
Hematological malignancy in non-remission at haploidentical transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of consolidative donor lymphocyte infusion following haploidentical transplantation for hematological malignancy in non-remission.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease-free survival rate at 1 year from transplantation
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
Consolidative DLI at 45 - 60 days from haploidentical transplantation. DLI dose is 1*10E5 CD3+ cells/kg.
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
| 16 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who underwent haploidentical transplantation for hematological malignancy in non-remission or hematological remission with positive MRD (molecular non-remission).
2. Patients who achieved hematological remission at day 30 from transplantation.
3. Patients who have a donor providing lymphocytes for DLI.
4. Patients who are 16 to 70 years old.
5. Patients in performance status of 0-2.
6. Patients whose major organ functions are preserved.
Key exclusion criteria
1. Patients with poorly controlled active infection.
2. Patients with Grade II-IV acute GVHD.
3. Patients with serious mental disorder.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Kanda |
Organization
Jichi Medical University Saitama Medical Center
Division name
Division of Hematology
Zip code
330-8503
Address
1-847 Amanuma-cho, Omiya-ku, Saitama-city, Saitama 330-8503, Japan
TEL
+81-48-647-2111
ycanda-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Kako |
Organization
Jichi Medical University Saitama Medical Center
Division name
Division of Hematology
Zip code
330-8503
Address
1-847 Amanuma-cho, Omiya-ku, Saitama-city, Saitama 330-8503, Japan
TEL
+81-48-647-2111
Homepage URL
shinichikako@asahi-net.email.ne.jp
Sponsor or person
Institute
Division of Hematology, Jichi Medical University Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research-KAKENHI-
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
Institutional Review Board of Jichi Medical University Saitama Medical Center
Address
1-847 Amanuma-cho, Omiya-ku, Saitama-city, Saitama 330-8503, Japan
Tel
+81-48-647-2111
m.kuroda@jichi.ac.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
| 2021 | Year | 03 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2028 | 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
| 2021 | Year | 03 | Month | 28 | Day |
Last modified on
| 2023 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049962
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| Registered date | File name |
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