UMIN-CTR Clinical Trial

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

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

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Bioregulatory

Institute

Department

Personal name

Organization

Grants from the Ministry of Education, Culture, Sports, Science and Technology of Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

愛媛大学医学部附属病院（愛媛県）

Date of disclosure of the study information

2010

Year

07

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2010

Year

07

Month

12

Day

Last modified on

2016

Year

01

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004697