UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002089
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute National Cancer Research Center Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002484

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.