UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017170 |
|---|---|
| Receipt number | R000019923 |
| Scientific Title | A multicenter pilot study of antithymocyte globulin in patients undergoing allogeneic peripheral blood stem cell transplantation |
| Date of disclosure of the study information | 2015/04/19 |
| Last modified on | 2021/04/28 11:51:36 |
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Basic information
Public title
A multicenter pilot study of antithymocyte globulin in patients undergoing allogeneic peripheral blood stem cell transplantation
Acronym
NJHSG-ATG
Scientific Title
A multicenter pilot study of antithymocyte globulin in patients undergoing allogeneic peripheral blood stem cell transplantation
Scientific Title:Acronym
NJHSG-ATG
Region
| Japan |
Condition
Condition
hematological malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of antithymocyte globulin in patients undergoing allogeneic peripheral blood stem cell transplantation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidences of CMV infection, hemorrhagic cystitis, and PTLD at 1 year
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 |
Interventions/Control_1
Thymoglobulin (rabbit ATG), 1mg/kg, day-2, -1
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who are eligible for allogeneic stem cell transplantation
(a) acute leukemia: CR1 or CR2
(b) lymphoma: PR or CR
(c) MDS: IPSS int-2 or high; WPSS high or very high
2. Age: 16-65 years old
3. Patients who have HLA-matched related or unrelated PBSCT donor
4. Donor age: 12-65 years old
5. Performance status: 0-2
6. Patients with adequate physical function (Cardiac, Hepatic, Renal, Pulmonary).
Key exclusion criteria
1. Patients who are positive for HBs antigen or HIV antibody.
2. Patients with severe mental illness
3. Women who are pregnant, of childbearing potential, or lactating.
4. Patients with active other malignancies.
5. Patients with active infectious disease.
6. Patients who had a history of myocardial infarction, or who needed treatment for heart failure within 1 year.
7. Patients with cirrhosis
8. Obese patients (body mass index [BMI; 35 or greater])
9. Patients with arrhythmia (CTCAE Grade 3 or more)
10. Patients who experienced serious hypersensitivity or anaphylaxis to antithymocyte globulin.
11. Patients who are not eligible for this study at the discretion of the investigator.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Shigematsu |
| Middle name | |
| Last name | Akio |
Organization
Hokkaido University Hospital
Division name
Department of Hematology
Zip code
060-8638
Address
N15 W7, Kita-Ku, Sapporo 060-8638, Japan
TEL
011-706-7214
shigema@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Sugita |
| Middle name | |
| Last name | Junichi |
Organization
Hokkaido University Hospital
Division name
Department of Hematology
Zip code
060-8638
Address
N15 W7, Kita-Ku, Sapporo 060-8638, Japan
TEL
011-706-7214
Homepage URL
http://www.njhsg.com/
sugitaj@med.hokudai.ac.jp
Sponsor or person
Institute
North Japan Hematology Study Group (NJHSG)
Institute
Department
Personal name
Funding Source
Organization
North Japan Hematology Study Group (NJHSG)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Clinical Research Administration, Hokkaido University Hospital
Address
N14 W5, Kita-ku, Sapporo, Hokkaido, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.ac.jp
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
| 2015 | Year | 04 | Month | 19 | 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
6
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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 19 | Day |
Last modified on
| 2021 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019923
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
