UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005138
Receipt number 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 18:41:25

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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 or person

Institute

Hematology, Hyogo College of Medicine

Institute

Department

Personal name



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

Value
https://center6.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