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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003905
Receipt No. R000004697
Scientific Title Phase I/II study of Aurora-A kinase peptide vaccine against hematological malignancies in combination with Pertussis vaccine (Pelita III strain) as an adjuvant.
Date of disclosure of the study information 2010/07/12
Last modified on 2016/01/12

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Basic information
Public title Phase I/II study of Aurora-A kinase peptide vaccine against hematological malignancies in combination with Pertussis vaccine (Pelita III strain) as an adjuvant.
Acronym Hematological malignancies-Pertussis vaccine combined Aurora-A kinase peptide vaccine trial-P1/2
Scientific Title Phase I/II study of Aurora-A kinase peptide vaccine against hematological malignancies in combination with Pertussis vaccine (Pelita III strain) as an adjuvant.
Scientific Title:Acronym Hematological malignancies-Pertussis vaccine combined Aurora-A kinase peptide vaccine trial-P1/2
Region
Japan

Condition
Condition Conventional therapy-resistant acute or chronic leukemia, elderly patients with hematological malignancies who are not eligible for standard chemotherapy and/or allogeneic or autologous hematopietic stem cell transplantation, relapsed acute or chronic leukemia and advanced phase of myelodysplastic syndrome after allogenic or autologous hematopietic stem cell transplantation, acute leukemia in 1st remission with high risk of relapse.
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Phase I/II study of Pertussis vaccine combined Aurora-A kinase peptide vaccine against refractory leukemias and advanced myelodysplastic syndrome that are not eligible for standard chemotherapies and/or allo/auto- hematopoietic stem cell transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Adverse event profile and anti-leukemia effect.
Key secondary outcomes Generation of Aurora-A kinase-specific CD8+ T-cell in peripheral blood, progression free survival, relapse rate and progression free survival rate at 3 month and 6 months after the induction of Aurora-A kinase peptide vaccination.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 Cohort1 patients receive 0.5mg of Aurora-A kinase peptide in combination with fixed 5x10e8/100 micro-litter of Pertussis vaccine.
Interventions/Control_2 Cohort2 patients receive 1.0mg of Aurora-A kinase peptide in combination with fixed 5x10e8/100 micro-litter of Pertussis vaccine.
Interventions/Control_3 Cohort3 patients receive 2.0mg of Aurora-A kinase peptide in combination with fixed 5x10e8/100 micro-litter of Pertussis vaccine.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Candidates should meet all following requirements.
(1)Patients with leukemias, myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative disease (MD/MPD) and myeloproliferative disease (MPD) diagnosed on the basis of WHO classification.
(2)Patients who are given their diagnoses.
(3)Patients who are not eligible for standard therapy, or who intend to take this therapy because they achieved the therapeutic insufficiency by standard therapy, or patients who desire this therapy but not standard therapy. Patients who have no clinical efficacy for longer than 4 weeks after previous therapy.
(4) Positve for HLA-A*0201 or A*2402.
(5)Leukemic cells in peripheral blood (PB) or bone marrow (BM) display augmented Aurora-A kinase mRNA 2.5 times more than that of PBMC, at least one time, by quantitative RT-PCR.
(6)At the initiation of vaccination, residual disease in BM or PB is confirmed by at least one of following methods.
(a)Persistent leukemic cells in periphery or BM.
(b)Overexpression of Aurora-A kinase mRNA by qRT-PCR.
(c) Residual leukemia is shown by leukemia-specific genetic markers including chromosomal analysis, FISH and chimeric genes.
(7) Leukemic blast in BM is <50%, and <50% in PB with >or= 500/microlitter of neutrophile count, >or=20,000/microlitter of platelet count, and >or= 7.0 g/dl of Hemoglobin.Without administration of Granulocyte-colony stimulating factor within 7 days, platelet count and Hb can be controlled by transfusions.
(8)Without or with well-controlled central nervous system lesion.
(9) Aged between >or= 20 y.o and <80 y.o.
(10) ECOG-scale Performance status 0-1.
(11) Functions of vital organs are preserved.
(12) Without other life-threatening diseases, and active overlapping cancers (including hematological malignancies).
(13) Patients can give written informed consents.
Key exclusion criteria (1) Patients with uncontrolled and active infectious disease including active tuberculosis.
(2) Patients suffering from severe complications including malignant hypertension, severe congestive heart failure, severe coronary disease, recent myocardial infarction within 3 months, end-staged liver cirrhosis, uncontrolled diabetes mellitus, severe pulmonary fibrosis, and active interstitial pneumonia, and so on.
(3) Patients who are pregnant or currently lactating.
(4) Patients who suffering from severe psychiatric disease.
(5) Patients who are already enrolled into other clinical trials.
(6) Patients who are once enrolled but ended with some reasons (to inhibit the double enrollment.)

Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Yasukawa
Organization Ehime University
Division name Department of Bioregulatory Medicine
Zip code
Address Shitsukawa, Toon, Ehime 791-0295, Japan
TEL 089-960-5296
Email yasukawa@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Fujiwara
Organization Ehime University
Division name Department of Bioregulatory
Zip code
Address Shitsukawa, Toon, 790-0152 Ehime, Japan
TEL 089-960-5296
Homepage URL
Email yunarief@m.ehime-u.ac.jp

Sponsor
Institute Department of Bioregulatory
Institute
Department

Funding Source
Organization Grants from the Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization
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 愛媛大学医学部附属病院(愛媛県)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 12 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
2010 Year 05 Month 24 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 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
2010 Year 07 Month 12 Day
Last modified on
2016 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004697

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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