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Name:
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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028370
Receipt No. R000030970
Scientific Title Prophylactic infusion of NK cell and gamma/delta chain positive T cell from transplantation donor for poor prognostic or refractory hematologic malignancy and solid tumor -Ibaraki Children's Hospital phase II study
Date of disclosure of the study information 2017/07/28
Last modified on 2017/09/17

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Basic information
Public title Prophylactic infusion of NK cell and gamma/delta chain positive T cell from transplantation donor for poor prognostic or refractory hematologic malignancy and solid tumor -Ibaraki Children's Hospital phase II study
Acronym ICH-NKDLI-16
Scientific Title Prophylactic infusion of NK cell and gamma/delta chain positive T cell from transplantation donor for poor prognostic or refractory hematologic malignancy and solid tumor -Ibaraki Children's Hospital phase II study
Scientific Title:Acronym ICH-NKDLI-16
Region
Japan

Condition
Condition Acute leukemia, malignant lymphoma, and solid tumor
Classification by specialty
Hematology and clinical oncology Pediatrics Child
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the safety and efficacy of preventive infusion of donor NK cell and TCR gamma delta chain positive T cell for refractory hematologic malignancy and solid tumor in an attempt to improve the prognosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Disease free survival rate at 1 year after infusion
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
Device,equipment
Interventions/Control_1 Patients who have undergone peripheral blood stem cell transplantation or bone marrow transplantation from HLA-4/8 to 6/8 matched family member for unfavorable hematologic or solid malignant neoplasm are eligible. On day+60 or more after transplant when the patients have no or grade 1 acute GVHD, peripheral blood mononuclear cells are collected from the same donor using Spectra Optia Apheresis System (Terumo BCT, Inc., Lakewood, Colorado, USA). The mononuclear cells collected were submitted to magnetic labeling and depletion of TCR alpha/beta positive T-cells and CD19 positive B-cells employing CliniMACS System (Miltenyi Biotec GmbH, Bergisch Gladbach, Germany) and CliniMACS TCR alpha/beta-Biotin Reagent System and CD19 Reagent System. The purified NK-cells and TCR gamma/delta positive T-cells are analyzed by flowcytometry and infused to the patients. The patients undergo physical examination, peripheral blood investigation, bone marrow analysis, and imaging study serially on day +30, +60, +90, +180, +360, +720 after infusion to investigate chimerism, engraftment, immunological recovery, disease condition, or side effect.
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
0 years-old <=
Age-upper limit
20 years-old >
Gender Male and Female
Key inclusion criteria (1)Histologically or cytologically diagnosed acute leukemia, or malignant lymphoma, or solid tumor (2)Age less than 20 years at diagnosis (3)Confirmed Eligible clinical entity (3-1)High Risk acute leukemia or malignant lymphoma (a)Primary induction failure at transplantation (b)In the first complete remission obtained after more than three courses of induction (c)In the first complete remission with detectable minimum residual disease (d)In the first complete remission with unfavorable cytogenetic or molecular features (e)Very early relapse within three years after diagnosis, the second complete remission but poor response or minimum residual disease against re-induction chemotherapy after relapse, the third or more advanced complete remission or not in remission after relapse (3-2)High risk solid tumor (a)MYCN-amplified, 1p-lost, or 11q-lost neuroblastoma (b)Not in remission (3-3)No HLA-match donor in family and no appropriate donor in unrelated donor bank or cord blood bank (3-4)Recurrent acute leukemia or malignant lymphoma after hematopoietic stem cell transplantation (3-5)Recurrent solid tumor (4)ECOG performance status score 0-1, if deterioration due to active disease, score 2 eligible (5)Appropriate organ function fulfilling following condition a)Serum concentration of total bilirubin, less than upper limit of normal range for age b)Serum concentration of creatinine, less than upper limit of normal range for age c)Serum concentration of cystatin C, less than 1.00 mg/L d)Pulse-oximetry saturation more than 97 percent awake and at rest breathing room air e)%Vital capacity, more than 70% by pulmonary function test (if patient more than 6 years old) f)Forced expiratory volume in 1 second%, more than 70% (if patient more than 6 years old) g)Plasma BNP, less than 40 pg/mL h)%Fractional shortening, more than 27% (6)All patients and/or their parents or legal guardians must sign a written informed consent
Key exclusion criteria (1)Germ line chromosomal abnormality other than trisomy 21
(2)Concurrent or prior malignant disease other than the original disease in interest or prior organ transplantation other than hematopoietic cell transplantation
(3)Congenital or acquired immunodeficiency
(4)Uncontrolled fungal, bacterial, or viral infection (including tuberculosis of HIV)
(5)Pregnant, lactating, or highly suspected to be pregnant
(6)Corrected QT interval by Fridericia, more than 0.45 second
(7)Active hemorrhage in central nervous system, fulfilling grade more than 3 on CTCAE version 4.0
(8)Consciousness disturbance, score less than 14 on Glasgow Coma Scale
(9)Obesity, by more than 30% of average weight for age.
(10)Considered to be unsuitable for entry for the study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisuke Kato, M.D.
Organization Ibaraki Children's Hospital
Division name Division of Pediatric Hematology and Oncology, Specialty Care Service, Pediatrics
Zip code
Address Futaba-dai 3-3-1, Mito, Japan
TEL 029-254-1151
Email keikato-ind@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Kato, M.D.
Organization Ibaraki Children's Hospital
Division name Division of Pediatric Hematology and Oncology, Specialty Care Service, Pediatrics
Zip code
Address Futaba-dai 3-3-1, Mito, Japan
TEL 029-254-1151
Homepage URL
Email keikato-ind@umin.ac.jp

Sponsor
Institute Ibaraki Children's Hospital
Institute
Department

Funding Source
Organization Ibaraki Children's Hospital
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 28 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
2017 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 28 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
2017 Year 07 Month 25 Day
Last modified on
2017 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030970

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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