UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002502
Receipt No. R000003061
Scientific Title "Add-back" therapy with HSV-TK gene transduced donor lymphocytes after T-cell-depleted haplo-identical hematopoietic stem cell transplantation
Date of disclosure of the study information 2009/09/17
Last modified on 2014/09/09

* 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 "Add-back" therapy with HSV-TK gene transduced donor lymphocytes after T-cell-depleted haplo-identical hematopoietic stem cell transplantation
Acronym Haploidentical transplantation using HSV-TK gene transduced lymphocyte
Scientific Title "Add-back" therapy with HSV-TK gene transduced donor lymphocytes after T-cell-depleted haplo-identical hematopoietic stem cell transplantation
Scientific Title:Acronym Haploidentical transplantation using HSV-TK gene transduced lymphocyte
Region
Japan

Condition
Condition High risk hematological malignancies, which require allogeneic stem cell transplantation therapy, without HLA- full match or 1 locus mismatch donors
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation the safety and effectiveness of T-cell depleted haplo-identical stem cell transplantation with add-back therapy of HSV-TK gene transduced donor lymphocyte.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Safety of HSV-TK gene transduced donor lymphocyte add-back therapy after T-cell depleted hapo-identical hematopoietic stem cell transplantation.
Immue-reconstitution, prvability of GVHD and it's control efficacy after HSV-TK gene transduced donor lymphocyte add-back.
Key secondary outcomes Provavility of infection, diasease free survival and overall survival after HSV-TK gene transduced donor lymphocyte add-back therapy afterT-cell depleted haplo-identical stem cell transplanation.

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 HSV-TK gene transduced lymphocyte add-back thrapy after T-cell depleted haplo-identical hematopoietic stem cell transplantation
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
60 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients satisfying at least one of the following requirements
(1) Patients during the first remission of acute myelogenous leukemia.
(2) Patients during the second or subsequent remission of acute myelogenous leukemia.
(3) Patients with myelodysplastic syndrome, classified as the sub-group predicting poor prognosis
(4) Patients with myelodysplastic syndrome dependent on blood transfusion.
(5) Patients during the first or subsequent chronic phase of chronic myelogenous leukemia or in its transitional phase
(6) Patients during the first remission of high-risk acute lymphocytic leukemia
2) Patients lacking any appropriate donor (both related and unrelated) whose HLA is serologically identical or a single antigen mismatched
3) Patients who don't have any donors to meet the eligibility criteria in the study
4) Patients between 20 and 60 years old, with life expectancy of 9 months or more after hematopoietic stem cell transplantation
5) Patients with ECOG performance status 0 or 1
Key exclusion criteria 1) Patients unlikely to stop the ongoing ganciclovir administration for the presentation of CMV infection or elevated blood CMV antigen level by the start of conditioning regimen.
2) Patients unlikely to stop the ongoing ACV administration by the start of conditioning regimen.
3) Patients whose ejection franction at rest is less than 50% when measured by echocardiography
4) Patients with diabetes mellitus poorly controlled despite continued insulin therapy
5) Patients with poorly controlled hypertension
6) Patients having treatment-requring allergy or allergy to any drugs used during this study
7) Patients with active infection
8) Patients with uncontrollable evident tumor cell invasion into the central nervous system
9) Patients with active double cancers
10) Patients with previous history of TBI or total lymph node irradiation (TLI)
11) Patienta tested positive for any of HIV antibody, HBs antigen and HCV antibody
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Heike
Organization National Cancer Center
Division name Immunotherapy Research Field, Translational Research Group, and Translational Medicine Department, Phase 1 Group, Exploratory Oncology Research & Clinical Trial Center
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email yheike@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuya Yamashita
Organization National Cancer Center Hospital
Division name Hematopoietic Stem Cell Transplantaion Division
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email tayamash@ncc.go.jp

Sponsor
Institute National Cancer 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 国立がんセンター中央病院

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 17 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
2009 Year 05 Month 22 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2009 Year 10 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 09 Month 15 Day
Last modified on
2014 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003061

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.