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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005138
Receipt No. R000006104
Scientific Title Donor NK cell infusion for patients after allogeneic hematopoietic stem cell transplantation
Date of disclosure of the study information 2011/02/25
Last modified on 2013/08/30

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Basic information
Public title Donor NK cell infusion for patients after allogeneic hematopoietic stem cell transplantation
Acronym Donor NK cell infusion for patients after allogeneic hematopoietic stem cell transplantation
Scientific Title Donor NK cell infusion for patients after allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym Donor NK cell infusion for patients after allogeneic hematopoietic stem cell transplantation
Region
Japan

Condition
Condition acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, chronic myelogenous leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objectives are to observe incidence of adverse events and graft-versus-host disease and to evaluate anti-tumor effect of donor NK cell infusion performed for molecular relapse after allogeneic hematopoietic stem cell transplantation as phase I/II study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Incidence of adverse events(grater than or equal to CTCAE grade 3), graft-versus-host disease(grater than or equal to grade 1) and anti-tumor effect
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Donor NK cell infusion
NK cell dose is limited by the number of contaminated T cells.
Available to infusion repetitively after 2 weeks interval.
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
15 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria The patient has molecular relapsed disease.
The patient has no other effective treatments.
Informed consent is obtained.
Key exclusion criteria The performance status is grater or equal to grade 2 (ECOG standard).
The patient is on graft-versus-host disease.
The patient has severe damages on heart, lung, kidney and liver.
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Ogawa
Organization Hyogo College of Medicine
Division name Hematology
Zip code
Address 1-1 Mukogawa-cho Nisinomiya-shi Hyogo-pref.
TEL 0798-45-6886
Email haplo@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Ikegame
Organization Hyogo College of Medicine
Division name Hematology
Zip code
Address 1-1 Mukogawa-cho Nisinomiya-shi Hyogo-pref.
TEL 0798-45-6886
Homepage URL
Email kame@hyo-med.ac.jp

Sponsor
Institute Hematology, Hyogo College of Medicine
Institute
Department

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
Address
Tel
Email

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 兵庫医科大学病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 25 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
2010 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 02 Month 25 Day
Last modified on
2013 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006104

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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