UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017748 |
|---|---|
| Receipt number | 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 09:22:50 |
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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
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
sezoe@bldon.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020560
