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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043766
Receipt No. 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 2021/03/28

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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.
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
Email 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
Email shinichikako@asahi-net.email.ne.jp

Sponsor
Institute Division of Hematology, Jichi Medical University Saitama Medical Center
Institute
Department

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
Email 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
2021 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049962

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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