UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002089 |
|---|---|
| Receipt number | R000002484 |
| Scientific Title | Phase 1 study of WT1 peptide vaccine therapy for high risk leukemia patients after hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2009/06/18 |
| Last modified on | 2013/12/21 09:37:25 |
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Basic information
Public title
Phase 1 study of WT1 peptide vaccine therapy for high risk leukemia patients after hematopoietic stem cell transplantation
Acronym
WT1 vaccine for high risk leukemia after HSCT - Phase 1
Scientific Title
Phase 1 study of WT1 peptide vaccine therapy for high risk leukemia patients after hematopoietic stem cell transplantation
Scientific Title:Acronym
WT1 vaccine for high risk leukemia after HSCT - Phase 1
Region
| Japan |
Condition
Condition
Acute myeloid leukemia, Acute lymphoblastic leukemia, Chronic myeloid leukemia blastic phase, Myelodysplastic syndrome with high risk of relapse and/or excess blasts
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assess the feasibility of WT1 peptide vaccine therapy for patients with increasing WT1 expression after hematopoietic stem cell transplantation and determine the optimal dose for phase 2 study.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safety and the immunological optimal dose of WT1 vaccine.
Key secondary outcomes
Efficacy, Over all survival, Progression free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
WT1 peptide vaccine
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Acute myeloid leukemia, Acute lymphoblastic leukemia, Chronic myeloid leukemia blastic phase, or Myelodysplastic syndrome with high risk of relapse (IPSS >=int-2 or WPSS >=high) or excess blasts (RAEB (FAB), RAEB-t (FAB), RAEB-1 (WHO2008), or RAEB-2 (WHO2008)).
2. Patients in hematological complete remission after allogeneic hematopoietic stem cell transplantation.
3. Patients with any one of HLA-A0201, HLA-A0206 or HLA-A2402 genotype.
4. Patients with confirmation of WT1 expression in the peripheral blood (>50copy/ugRNA) or bone marrow (>1500copy/ugRNA) by real-time PCR assay at any time after the diagnosis of leukemia.
5. More than 28 days from reducing immunosuppressive drugs to 3mg/kg of cyclosporin or 0.1mg/kg of tacrolimus and 10 mg/body of prednisolone or less.
6. Patients with ECOG performance status of 0 to 2
7. Patients aged 20 years old and above with no upper limit.
8. Patients with well preserved main organ function. (bone marrow, heart, lung, liver, kidney etc.)
Neutrophils above 1,000
Platelets above 50,000
GOT less than 5-times the upper limit of normal
GPT less than 5-times the upper limit of normal
Bilirubin less than 3-times the upper limit of normal
Serum creatinine less than 3-times the upper limit of normal
Saturation above 95% at room air
No electrocardiogram abnormalities which requires treatment.
9. Patients who are expected to survive for at least 3 months.
10. Patients with written informed consent.
Key exclusion criteria
Patients with any one of the criteria are ineligible.
1. Patients with active acute GVHD or extended chronic GVHD (including bronchiolitis obliterans or bronchiolitis obliterans organizing pneumonia).
2. Patients receiving over permitted dose of immunosuppressive drugs or corticosteroids .
3. Patients with active infection including positive cytomegalovirus antigenemia which requires treatment.
4. Patients with positive HBs antigen, or HCV antibody. Patients with active hepatitis or cirrhosis.
5. Pregnant or breast feeding patients. Patients who have a possibility of pregnancy or desire for baby.
6. Patients with active autoimmune disease (including hypothyroidism, idiopathic thrombocytopenic purpura, autoimmune hepatitis) or with a history of those diseases.
7. Patients with active interstitial pneumonia or its history.
8. Patients with a history of allergy or severe adverse reaction against biological agents.
9. Patients with a severe psychological disorder and considered unable to obtain informed consent for the study.
10. Patients with uncontrollable central nervous invasion.
11. Patients participating in other clinical trials*.
* If the safety and anti-tumor effect of vaccine therapy is obviously not considered to be affected by the other clinical trials, the patient doesn't need to be excluded.
12. Patients who are considered ineligible for the study.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Heike |
Organization
National Cancer Research Center Hospital
Division name
Department of Clinical Trial Coordination and Developmental Therapeutics
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Cancer Research Center Hospital
Division name
Support Center for Patients and Families
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3547-5293
Homepage URL
Sponsor or person
Institute
National Cancer Research Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
国立がん研究センター中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 06 | Month | 18 | 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
| 2008 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 18 | Day |
Last modified on
| 2013 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002484
