UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028083 |
|---|---|
| Receipt number | 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 | 2020/06/11 15:42:41 |
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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 | Toyotaka |
| Middle name | |
| Last name | Kawamata |
Organization
The Institute of Medical Science, The University of Tokyo
Division name
Department of Hematology/Oncology, IMSUT Hospital
Zip code
108-8639
Address
4-6-1 Shirokanedai, Minato-ku, Tokyo
TEL
03-5449-8111
dctsm@ims.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Center for |
| Middle name | |
| Last name | Translational Research |
Organization
The Institute of Medical Science, The University of Tokyo
Division name
Center for Translational Research, IMSUT Hospital
Zip code
108-8639
Address
4-6-1 Shirokanedai, Minato-ku, Tokyo
TEL
03-5449-5462
Homepage URL
dctsm@ims.u-tokyo.ac.jp
Sponsor or person
Institute
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Institute
Department
Personal name
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
IMSUT hospital Institutional Review Board (IRB), The Institute of Medical Science, The University of Tokyo
Address
4-6-1 Shirokanedai, Minato-ku, Tokyo
Tel
03-5449-5462
imsuttro@ims.u-tokyo.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
| 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
10
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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 03 | Day |
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
| 2020 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031964
| Research Plan | |
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| Registered date | File name |
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