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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028083
Receipt No. R000031964
Scientific Title Phase I study of WT1-expressing human artificial adjuvant vector cells (aAVC-WT1) for patients with relapsed or refractory acute myeloid leukemia
Date of disclosure of the study information 2017/07/05
Last modified on 2018/06/20

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Basic information
Public title Phase I study of WT1-expressing human artificial adjuvant vector cells (aAVC-WT1) for patients with relapsed or refractory acute myeloid leukemia
Acronym Phase I study of WT1-expressing human artificial adjuvant vector cells (aAVC-WT1) for patients with relapsed or refractory acute myeloid leukemia
Scientific Title Phase I study of WT1-expressing human artificial adjuvant vector cells (aAVC-WT1) for patients with relapsed or refractory acute myeloid leukemia
Scientific Title:Acronym Phase I study of WT1-expressing human artificial adjuvant vector cells (aAVC-WT1) for patients with relapsed or refractory acute myeloid leukemia
Region
Japan

Condition
Condition relapsed or refractory acute myeloid leukemia (AML)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore the safety of aAVC-WT1, and secondaly to explore immunological effects (NKT cell-specific immune response) and clinical efficacy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Safety
(1) Occurence of Dose Limiting Toxicity and determination of Maximum Tolerated Dose
(2) Exploration of adverse events
(3) Statistical analysis on examinations related to safety evaluation
Key secondary outcomes Immunological effects (NKT cell-specific immune response and amplification rate)
Clinical efficacy
(1) Hematological effect: Response rate(CR, PR, CRi)
(2) Longitudinal change of WT1 mRNA copies
(3) Overall survival

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
Vaccine
Interventions/Control_1 Intravenous administraion of aAVC-WT1 followed by 3+3 dose escalation scheme
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Ability to give patients' consent by written informed consent form
Age >= 20
Relapsed or refractory primary/secondary AML diagnosed by 2016 WHO classification
Awareness of AML
Peripheral blood WT-1 mRNA => 1500 copies/microgram ever before
ECOG Performance Status <= 2
Life expectancy >= 12 weeks
Submission of preserved specimens at screening and newly collected bone marrow/bone marrow aspiration
Key exclusion criteria Acute promyelocytic leukemia, BCR-ABL-positive leukemia
Central nervous system infiltration/extramedullary AML
Sustained non-hematological toxicity ( >= Grade 2) related to prior therapy for AML
Clinically relevant graft-versus-host disease required for treatment
Duration from prior therapy to administration:
1) Systemic immunosuppressive drugs including steroids <= 14 days
2) Investigational drugs, products, or medical devices <= 4 weeks
3) Hematopoietic stem cell transplantation <= 8 weeks
4) Chemotherapy (excluding hydroxyurea for leukemia control)

Laboratory examination <= 14 days prior to registration:
1) AST/ALT >= 3 times upper limit of normal level (ULN)
2) Total serum bilirubin level >= 2 times ULN
3) Lymphocytes (peripheral blood) <= 5.0 x 10^2 /microliter
4) Estimated glomerular filtration rate < 30 mL/min
5) SpO2 < 94% (room air)
Other active malignancies
Angina pectoris, acute myocardial infarction, congestive heart failure (>= NYHA class 3), or severe abnormality on electrocardiography <= 12 weeks prior to 1st administration
Poor control hypertension, interstitial pneumonia, pulmonary fibrosis, chronic obstructive pulmonary disease (>= stage 3)
Disseminated intravascular coagulation
Active/poor control infection, HIV infection
Active hepatitis B/C virus infection, other active liver disease
Congenital/acquired immune deficiency
Pregnant, possible pregnant, breast feeding women
Poor control diabetes mellitus
Known hypersensitivity to reagents (human albumin, etc.), additives (galactose/ceramide), antibiotics (streptomycin/gentamicin) and heterologous proteins (fetal bovine serum/porcine trypsin)
Principal investigator/co-investigator judgement
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toyotaka Kawamata
Organization The Institute of Medical Science, The University of Tokyo
Division name Department of Hematology/Oncology, IMSUT Hospital
Zip code
Address 4-6-1 Shirokanedai, Minato-ku, Tokyo
TEL 03-5449-8111
Email dctsm@ims.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Center for Translational Research
Organization The Institute of Medical Science, The University of Tokyo
Division name Center for Translational Research, IMSUT Hospital
Zip code
Address 4-6-1 Shirokanedai, Minato-ku, Tokyo
TEL 03-5449-5462
Homepage URL
Email dctsm@ims.u-tokyo.ac.jp

Sponsor
Institute IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Institute
Department

Funding Source
Organization National Research and Development Institute Agency RIKEN
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
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 05 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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 05 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 05 Day
Last modified on
2018 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031964

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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