UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002502 |
|---|---|
| Receipt number | 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 16:03:45 |
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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
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
tayamash@ncc.go.jp
Sponsor or person
Institute
National Cancer 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003061
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