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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017748
Receipt No. R000020560
Scientific Title A phase Ia /Ib study of vaccination with NY-ESO-1 protein, Poly ICLC and mogamulizumab in patients with Adult T cell leukemia/lymphoma expressing NY-ESO-1 antigen
Date of disclosure of the study information 2015/06/01
Last modified on 2015/05/31

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Basic information
Public title A phase Ia /Ib study of vaccination with NY-ESO-1 protein, Poly ICLC and mogamulizumab in patients with Adult T cell leukemia/lymphoma expressing NY-ESO-1 antigen
Acronym A clinical study of combination therapy with NY-ESO-1 vaccine and mogamulizumab for ATLL
Scientific Title A phase Ia /Ib study of vaccination with NY-ESO-1 protein, Poly ICLC and mogamulizumab in patients with Adult T cell leukemia/lymphoma expressing NY-ESO-1 antigen
Scientific Title:Acronym A clinical study of combination therapy with NY-ESO-1 vaccine and mogamulizumab for ATLL
Region
Japan

Condition
Condition Adult T cell Leukemia/Lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A phase Ia /Ib study of vaccination with NY-ESO-1 protein, Poly ICLC and mogamulizumab in patients with Adult T cell leukemia/lymphoma expressing NY-ESO-1 antigen
Basic objectives2 Others
Basic objectives -Others 1a Safety
1b biological effect (Immunological effect)
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes 1a To evaluate the safety of NY-ESO-1 vaccination with mogamulizumab.
1b
1. To evaluate the induction of NY-ESO-1 specific immune responses by vaccination with or after mogamulizumab.

2. To evaluate the safety.
Key secondary outcomes 1a To observe the induction of NY-ESO-1 specific immune responses.
1b
1 To evaluate the tumor responses by NY-ESO-1 vaccination with or after mogamulizumab.

2 To evaluate additional immune responses.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 Simultaneous administration of NY-ESO-1+PolyICLC and mogamulizumab
Interventions/Control_2 Sequential administration of NY-ESO-1+PolyICLC after mogamulizumab
Interventions/Control_3 mogamulizumab without vaccination
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
89 years-old >=
Gender Male and Female
Key inclusion criteria 1. Relapsed or refractory ATLL patients with ATLA antibody.
2. <=80 and 20>= years of age.
3. Indication for treatment with mogamulizumabb.
4. No history of treatment with immunotherapy with NY-ESO-1 , or mogamulizumab within 4 months before enrollment.
5. ATLL with expression of NY-ESO-1.
6. ECOG performance status of 0 to 2.
7. Women of child-bearing potential and men must agree to use adequate contraception for the duration of study participation.
8. Sign an Informed Consent form.
Key exclusion criteria 1. Severe underlying diseases.
2. The patient has at least one clinical laboratory value as follows:
1) Absolute neutrophil count <1.500/mm3
2) Hemoglobin <8.0g/dL (blood transfusion is acceptable)
3) Platelet count < 50,000/mm3
4) Serum total bilirubin>1.5*ULN (except for patient with Gilberts syndrome for whom the limit is 2*ULN)
5) AST> 2*ULN (upper limit of normal) and ALT> 2*ULN
6) Serum creatinine > 1.5*ULN
7) Corrected Serum calcium > 11mg/dL
8) Percutaneous arterial oxygen saturation by pulse oximetry (SpO2) < 90%
3. Positive for HCV antibody, HIV.
4. Positive for HBs antigen or HBs antibody or HBc antibody, and HBV-DNA is over the limit of quantification.
5. Other malignancies within 5 years.
6. Needs treatment with corticosteroids, or any other immunosuppressive agents.
7. Any autoimmune disease.
8. Any history of severe hypersensitivity.
9. Any active infectious complication.
10. Uncontrolled bleeding disorder.
11. Pregnant or lactating.
12. Investigator considers to be inappropriate to participate in this study.



Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuzuru Kanakura
Organization Osaka University Graduate School of Medicine
Division name Department of Hematology and Oncology
Zip code
Address 2-2 Yamada-Oka Suita
TEL +81-6-6879-3871
Email kanakura@bldon.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sachiko Ezoe
Organization Osaka University Hospital
Division name Department of Medecal innovation
Zip code
Address 2-2 Yamada-Oka Suita
TEL +81-6-6879-3871
Homepage URL
Email sezoe@bldon.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Hematology and Oncology, Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Immunology Frontier Research Center, Osaka University
National Cancer Center
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 大阪大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 01 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 Open public recruiting
Date of protocol fixation
2014 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 10 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 04 Month 01 Day
Date trial data considered complete
2018 Year 06 Month 30 Day
Date analysis concluded
2018 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 05 Month 31 Day
Last modified on
2015 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020560

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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