UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008823 |
|---|---|
| Receipt number | R000010347 |
| Scientific Title | Phase II clinical trial of personalized peptide vaccination for patient with advanced hematological malignancy resistant to standard therapies . |
| Date of disclosure of the study information | 2012/08/31 |
| Last modified on | 2019/12/06 14:48:34 |
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Basic information
Public title
Phase II clinical trial of personalized peptide vaccination for patient with advanced hematological malignancy resistant to standard therapies .
Acronym
Phase II clinical trial of personalized peptide vaccination for patient with advanced hematological malignancy resistant to standard therapies .
Scientific Title
Phase II clinical trial of personalized peptide vaccination for patient with advanced hematological malignancy resistant to standard therapies .
Scientific Title:Acronym
Phase II clinical trial of personalized peptide vaccination for patient with advanced hematological malignancy resistant to standard therapies .
Region
| Japan |
Condition
Condition
hematological malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to investigate the immunity-enhancing effects of personalized peptide vaccination for patient with malignancy resistant to standard therapies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Immune-enhancing effects (changes in anti-peptide IgG titers in plasma)
Key secondary outcomes
1.Analyze the correlation between enhancement of peptide specific antibody and all over survival.
2. Adverse events of peptide vaccination. Adverse events are evaluated by the NCI-CTCAE.
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
| Medicine | Vaccine |
Interventions/Control_1
The right peptides (up to 4 peptides) for vaccination to individual patients will be selected in consideration of the pre-existing host immunity assessed by the titers of anti-peptide IgG before vaccination, and subcutaneously injected with incomplete Freund's adjuvant every week (3.0 mg/each peptide; 6 times/cycle).
If the patients want to continue the vaccination after completion of the first cycle of 6 vaccinations, the peptide vaccination will be allowed to continue .
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects must satisfy the following conditions.
1) Patients must be diagnosed as hematological malignancy resistant to standard therapies.
2) Patients must be at a score level 0-1 of ECOG performance status.
3) Patients must have IgGs reactive to at least two of the candidate peptides restricted to the patient's HLA types.
4)Patients must be expected to survive more than 3 months.
5) Patient's laboratory data must satisfy the followings:
WBC is more than 2,500/mm3
Lymphocyte is more than 900/mm3
Hb is more than 8.0g/dl
Platelet is more than 80,000/mm3
Serum Creatinine is less than 2 times the ULN
Total bilirubin are less than 2 times the ULN.(However, 2.5 or less times in the case of the patient of constitutional jaundice.)
6) Patients must be more 18 year-old.
7) Written informed consent must be obtained from patients.
8) Patients must be positive for HLA-A2, A24, A26, A3, A11, A31 or A33.
Key exclusion criteria
The following patients must be excluded:
1) Patients with severe underlying diseases/conditions (active and severe infectious diseases, circulatory diseases, respiratory diseases, ranal diseases, immunodeficiencies, disturbance of coagulation, et al).
2) Patients with the past history of severe allergic reactions.
3) (Females) Pregnant or nursing patients. Patients desiring future fertility.
(Males) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination.
4) Patients who are judged inappropriate for entry to this clinical trial by doctors.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Yutani |
Organization
Kurume University
Division name
Cancer Vaccine Center
Zip code
Address
Kokubu-machi 155-1, Kurume, Fukuoka 839-0863
TEL
0942-27-5210
yutani@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yamada |
Organization
Kurume University
Division name
Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Zip code
Address
67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL
0942-31-7744
Homepage URL
akiymd@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University Cancer Vaccine Center
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2012 | Year | 08 | 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
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 08 | 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
| 2012 | Year | 08 | Month | 31 | Day |
Last modified on
| 2019 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010347
