UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002105
Receipt No. 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

* 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 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
Email

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
Email

Sponsor
Institute Department of Pediatrics, Shinshu University School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002567

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.