UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028456 |
|---|---|
| Receipt number | R000032577 |
| Scientific Title | Open-labeled, non-randomized, single institute study of dendritic cell therapy using artificial antigen or tumor lysate for hematological malignancies |
| Date of disclosure of the study information | 2017/07/31 |
| Last modified on | 2021/02/09 11:02:47 |
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Basic information
Public title
Open-labeled, non-randomized, single institute study of dendritic cell therapy using artificial antigen or tumor lysate for hematological malignancies
Acronym
Dendritic cell therapy using artificial antigen or tumor lysate for hematological malignancies
Scientific Title
Open-labeled, non-randomized, single institute study of dendritic cell therapy using artificial antigen or tumor lysate for hematological malignancies
Scientific Title:Acronym
Dendritic cell therapy using artificial antigen or tumor lysate for hematological malignancies
Region
| Japan |
Condition
Condition
Hematological malignancies
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to investigate the safety and the efficacy of dendritic cell vaccination using artificial antigens or tumor lysate for patients with refractory or relapsed hematological malignancies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Adverse events, Immunological response, Efficacy
Key secondary outcomes
Progression free survival, Overall survival
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
| Vaccine |
Interventions/Control_1
Patients are injected intradermally at axilla or inguinal region with dendritic cells pulsed with artificial antigens or tumor lysate (approximately 1x107). At the same time, OK432 (0.5-3KE) is injected subcutaneously in the vicinity of dendritic-cell-injected site. Injection of dendritic cells is performed every two weeks seven times. WT1 peptide (HLA-A*2402-restricted, modified p235-243 peptide and HLA-A*0201-restricted p126-134 peptide) peptide are employed for artificial antigens. Safety and efficacy are evaluated after seventh DC vaccination.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with refractory or relapsed hematological malignancies
2. Performance Status; 0-2
3. Survival period is expected more than 4 months
4. HLA-A*2402, 0201 or 0206 positive
5. Meet the following criteria for organ functions
1) WBC more than 2,500/microliter, Hemoglobin more than 9.0 g/dl, Platelet more than 90,000/microliter
2) Serum AST/ALT less than 2.5 folds of the upper normal limit
3) Serum bilirubin less than1.5 folds of the upper normal limit
4) Serum Albumin more than 3.0g/dl
5) Serum creatinine within normal limitation
6) No serious ECG abnormality
6. Patients can tolerate blood component collection (apheresis) to collect peripheral blood mononuclear cells.
7. Informed consent has been obtained.
Key exclusion criteria
1. There is deep-seated active infection.
2. There are severe complications including malignant hypertension, cardiac failure, liver cirrhosis, severe DM, severe lung disease, active interstitial pneumonitis.
3. Patients who have complications are considered inappropriate for the trial.
4. There are other malignancies.
5. Pregnant or lactating woman.
6. Past history of severe drug allergy.
7. There is severe psychiatric disease.
8. The patient is considered inappropriate for the trial by a responsible doctor.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Ogasawara |
Organization
Sapporo Hokuyu Hospital
Division name
Dept. of Internal Medicine
Zip code
003-0006
Address
6-6-5-1 Higashisapporo Shiroishiku Sapporo
TEL
011-865-0111
ogasawara@hokuyu-aoth.org
Public contact
Name of contact person
| 1st name | Ikumi |
| Middle name | |
| Last name | Yamada |
Organization
Sapporo Hokuyu Hospital
Division name
Cellular Immunotherapy Center
Zip code
003-006
Address
6-6-5-1 Higashisapporo Shiroishiku Sapporo
TEL
011-865-0111
Homepage URL
i.yamada0414@hokuyu-aoth.org
Sponsor or person
Institute
Sapporo Hokuyu Hospital
Institute
Department
Personal name
Funding Source
Organization
Sapporo Hokuyu Hospital
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
Sapporo Hokuyu Hostital IRB
Address
6-6-5-1 Higashisapporo Shiroishiku Sapporo
Tel
011-865-0111
shiori-t@hokuyu-aoth.org
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 | 31 | 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
Suspended
Date of protocol fixation
| 2009 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2002 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | 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 | 31 | Day |
Last modified on
| 2021 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032577
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