UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000872 |
|---|---|
| Receipt number | R000001049 |
| Scientific Title | Predetermined Minor Histocompatibility Antigen-based Therapeutic or Prophylactic Peptide Vaccinations for Patients with Recurred Malignancies or Patients with High-Risk Malignancies Follwoing Allogeneic Hematopoietic Cell Transplantation. |
| Date of disclosure of the study information | 2007/11/01 |
| Last modified on | 2015/11/01 11:58:26 |
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Basic information
Public title
Predetermined Minor Histocompatibility Antigen-based Therapeutic or Prophylactic Peptide Vaccinations for Patients with Recurred Malignancies or Patients with High-Risk Malignancies Follwoing Allogeneic Hematopoietic Cell Transplantation.
Acronym
Prevention or Treatment of Recurring Malignancies after Allongeneic Transplantation with Minor Antigen Peptides
Scientific Title
Predetermined Minor Histocompatibility Antigen-based Therapeutic or Prophylactic Peptide Vaccinations for Patients with Recurred Malignancies or Patients with High-Risk Malignancies Follwoing Allogeneic Hematopoietic Cell Transplantation.
Scientific Title:Acronym
Prevention or Treatment of Recurring Malignancies after Allongeneic Transplantation with Minor Antigen Peptides
Region
| Japan |
Condition
Condition
(1) Therapeutic vaccine: Any hematological malignancies recurred after allogineic hematopoietic transplanation as follows (RAEB, CMML, AML, ALL, CML, Multiple Myeloma, NHL).
(2) Prophylactic vaccine: Hematological malignancies with high risk of relapse after allogineic hematopoietic transplanation as follows (RAEB, CMML, AML in >=3CR/non-CR or any AML with M0/M6/M7 FAB type, ALL in >=2CR/non-CR, CML in >=2CP or >=AP, Multiple Myeloma in PD, NHL in non-CR).
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This phase I study evaluates the safety, the immunological response and the clinical outcome of a vaccination with minor histocompatiblity antigenic peptides for post-transplant patients either with recurred hematological malignancies (treatment) or with high-risk hematological malignancies as adjuvant.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
(1) Frequencies of acute GVHD greater than grade 3, or extensive chronic GVHD with 13 days after the last (5th) vaccination.
(2) Frequencies of non-hematological toxicity greater than grade 3 by NCI-CTC criteria.
Key secondary outcomes
(1) Complete remission rate within 3 weeks after the last (5th) vaccine (in therapeutic settings only).
(2)Immune responses by flowcytomeric analysis (tetramer or cytokine production) and DTH after vaccine completion and duration of immune response.
(3)Tolerable maximal dose of vaccine.
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
| Vaccine |
Interventions/Control_1
Cohorts of 3-6 patients with disease recurrence (for treatment) or with high risk of disease relapse (for prevention) wreceive escalating doses (4 steps; 0.03mg, 0.3mg, 1.0mg, 3.0mg) of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of the 5th vaccination, patients are examined for 3 weeks for full evaluation. Follow-up period may be extended if necessary.
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
(1) Patients who are planned to receive allogeneic hematopoietic cell transplantation or post-transplant patients.
(2) Patients positive for HLA-A*24:02 (in case of ACC-1 minor antigen); HLA-B*4402 or B*44:03 (in case of ACC-2 minor antigen); HLA-A*02:01 or A*02:06 (in case of HA-1 minor antigen), HLA-B*4402 or B*44:03 (in case of ACC-6 minor antigen). Patients receiving 1>= eligible minor antigen-mismatched (listed above) transplant.
(3) Preserved major organ function.
(4) WHO performance status between 0 and 2.
(5) Written informed consent.
(6) More than 60 days after transplant for the first vaccination.
Key exclusion criteria
(1) CNS involvement or uncontrollable extramedullary disease.
(2) Severe infections (including active tuberculosis) or double cancer.
(3) Patients treated with major tranquilizer or antidepressant.
(4) One of the following: positive HBs antigen, seropositive to HCV, seropositive to HIV, seropositive to HTLV-1, seropositive to STS.
(5) Other reasons not eligible for vaccination (decision by physicians).
(6) Past history of acute GVHD >= grade 3.
(7) With more than grade 3 non-hematological toxicity at 10 days prior to vaccination.
(8) Within 10 days after previous chemotherapy and neutrophil counts less than 200/mm^3.
(9) On corticosteroid treatment.
(10) Lack of availability for immunological and clinical follow-up assessments.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akatsuka, Yoshiki |
Organization
Aichi Cancer Center Research Institute
Division name
Division of Immunology
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
TEL
052-762-6111
yakatsuk@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Taji |
Organization
Aichi Cancer Center Center Hospital
Division name
Department of Hematology & Cell Therapy
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
TEL
052-762-6111
Homepage URL
http://www.pref.aichi.jp/cancer-center/300/313/313-10/00.html
men-ekiryoho@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Research Institute
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology; Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2007 | Year | 11 | 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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Eight patients completed the vaccination (as of June 30, 2014).
Management information
Registered date
| 2007 | Year | 10 | Month | 31 | Day |
Last modified on
| 2015 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001049
