UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002105 |
|---|---|
| Receipt number | R000002567 |
| Scientific Title | Clinical trial for effectiveness and safety of WT1 peptide-pulsed allogeneic dendritic cell therapy for childhood patients with chemotherapy-resistant leukemia. |
| Date of disclosure of the study information | 2009/06/23 |
| Last modified on | 2009/06/22 21:22:27 |
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Basic information
Public title
Clinical trial for effectiveness and safety of WT1 peptide-pulsed allogeneic dendritic cell therapy for childhood patients with chemotherapy-resistant leukemia.
Acronym
Allogeneic dendritic cell therapy for pediatric leukemia.
Scientific Title
Clinical trial for effectiveness and safety of WT1 peptide-pulsed allogeneic dendritic cell therapy for childhood patients with chemotherapy-resistant leukemia.
Scientific Title:Acronym
Allogeneic dendritic cell therapy for pediatric leukemia.
Region
| Japan |
Condition
Condition
pediatric leukemia
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This phase I/phase II clinical trial for effectiveness and safety is WT1 peptide-pulsed allogeneic dendritic cell therapy for pediatric patients with chemotherapy-resistant leukemia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Primary endpoint of this clinical trial is to evaluate the toxicities and adverse events of the therapy.
Key secondary outcomes
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 | Vaccine |
Interventions/Control_1
Cultured dendritic cells of 1X107/dose are administered to the patient subcutaneously. This therapy is repeated every two-week, total 7 times.
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
| Not applicable |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Leukemic patient who relapsed after first stem cell transplantation and received SCT from his or her parent or sibling as a donor.
2.Donor cells are engrafted to the patient. Abnormal cells are not found in bone marrow or peripheral blood.
3.Expression of WT1 in the tumor cells at relapse is more than 102 copies per microgram RNA.
4.Karnofsky score of performance status is between 80 to 100.
5.Age of the patient is less than 20. Both sex are applicable.
6.No significant complications revealed by blood and urine examinations. Blood data within 7 days before registration should meet the following criteria.
a. WBC more than 1,000 per microlitter and Hb more than 7.5g per dl and platelet more than 30,000 per microlitter. Bleeding time and clotting time should be normal, regardless of transfusion dependency.
b. AST and ALT should be less than 2 times of normal range of the facilities. Total bilirubin less than 2.0 mg/dl.
c. Serum creatinin less than 1.0 mg/dl.
d. Acute GVHD stage less than 2.
7.Physicians fully explain about the clinical study to the patient or alternative and receive informed consent from them.
Key exclusion criteria
1.Patient with refractory GVHD.
2.Patient with active infections.
3.Patient wit thrombotic microangiopathy.
4.Patient with hepatic vein thrombosis.
5.Patient with early relapse.
6.Patient with mental, or familial, or geographycal obstacles to perform the trial.
7.Patient who is judged by the physician as not to be appropriate for the therapy.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiohara Masaaki |
Organization
Shinshu University School of Medicine
Division name
Department of Pediatrics
Zip code
Address
Asahi 3-1-1, Matsumoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shinshu University School of Medicine
Division name
Department of Pediatrics
Zip code
Address
TEL
0263-35-4600
Homepage URL
Sponsor or person
Institute
Department of Pediatrics, Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 06 | Month | 23 | 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
Date of protocol fixation
| 2009 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | 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 | 22 | Day |
Last modified on
| 2009 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002567
