UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018645 |
|---|---|
| Receipt number | R000021586 |
| Scientific Title | A phase II study of antithymocyte globulin in patients undergoing HLA-matched allogeneic peripheral blood stem cell transplantation |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2022/09/18 10:06:31 |
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Basic information
Public title
A phase II study of antithymocyte globulin in patients undergoing HLA-matched allogeneic peripheral blood stem cell transplantation
Acronym
JSCT-ATG15
Scientific Title
A phase II study of antithymocyte globulin in patients undergoing HLA-matched allogeneic peripheral blood stem cell transplantation
Scientific Title:Acronym
JSCT-ATG15
Region
| Japan |
Condition
Condition
AML,ALL,HL,NHL
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and efficacy of antithymocyte globulin (Thymoglobulin 1mg/kg, day -2, -1) in patients undergoing HLA-matched allogeneic peripheral blood stem cell transplantation after myeloablative conditioning
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of grade III-IV acute GVHD at 100 days
Key secondary outcomes
1. Engraftment at 100 days.
2. The incidence of acute GVHD and chronic GVHD at 100 days, 1 year, and 2 years.
3. Non-relapse mortality at 100 days, 1 year, and 2 years.
4. The incidence of relapse at 100 days, 1 year, and 2 years.
5. Disease-free survival at 100 days, 1 year, and 2 years.
6. Overall survival at 100 days, 1 year, and 2 years.
7. The incidence of infectious event at 100 days, 1 year, and 2 years.
8. GVHD free, relapse free survival (GRFS) at 100 days, 1 year, and 2 years.
9. The proportion of patients who stopped immunosuppressive drugs within 1 year and 2 year.
10. Grade 3-4 non-hematologic toxicity within 100 days.
11. Subgroup analysis subgroup analysis according to conditioning regimen.
12. Subgroup analysis subgroup analysis according to disease risk index (DRI)
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
1. Conditioning regimen
The definition of myeloablative conditioning regimen includes iv Busulfan > 7.2 mg/kg or Melphalan > 140 mg/m2 or TBI > 8 Gy.
:Cyclophosphamide (120 mg/kg) + TBI (12Gy/6fr)
:iv Busulfan (12.8 mg/kg) + Cyclophosphamide (120 mg/kg)
:Fludarabine (120-180 mg/m2) + iv Busulfan (12.8 mg/kg)
2. GVHD prophylaxis
Cyclosporine or Tacrolimus + MTX (day1: 10mg/m2, day 3, 6 (11): 7mg/m2)
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
| 15 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients who have hematologic malignancies as defined at least one of the following:
a) Acute Leukemia, CR
b) Myelodysplastic syndrome
intermediate-II, high as defined by IPSS
high, very high as defined by WPSS
c) Lymphoma, CR or chemosensitive PR
2.Age: 15-60 years old.
3.Patients who have HLA 8/8 matched related or unrelated peripheral blood stem cell donor
4.Performance status: 0-2
5.Patients with adequate physical function (Cardiac, Hepatic, Renal, Pulmonary).
6.Patients who give written informed consent to participate in the study.
Key exclusion criteria
1. Patients who are positive for HIV antibody.
2. Patients with active other malignancies.
3. Patients with active infectious disease.
4. Women who are pregnant, of childbearing potential, or lactating.
5. Patients who experienced serious hypersensitivity or anaphylaxis to antithymocyte globulin.
6. Patients who has a prior history of allogeneic transplantation.
7. Patients who are not eligible for this study at the discretion of the investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Sugita |
Organization
Hokkaido University Hospital
Division name
Department of Hematology
Zip code
060-8638
Address
060-8638 Sappor
TEL
011-
jsct-office@umin.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Sugita |
Organization
JSCT
Division name
ATG15-DC
Zip code
104-0031
Address
104-0031
TEL
03-6225-2025
Homepage URL
jsct-office@umin.ac.jp
Sponsor or person
Institute
JSCT
Institute
Department
Personal name
Funding Source
Organization
Resarch Foundation for Community Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital
Address
060-8638
Tel
011
jsct-office@umin.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 | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1038/s41409-020-0985-3
Publication of results
Unpublished
Result
URL related to results and publications
https://doi.org/10.1038/s41409-020-0985-3
Number of participants that the trial has enrolled
77
Results
Low-dose ATG as a GVHD prophylaxis showed safety and efficacy for the prevention of both
acute and chronic GVHD in HLA-matched PBSCT
using myeloablative conditioning.
Results date posted
| 2022 | Year | 09 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Sex (Male / Female):40 / 32
Age (median years (range)):46.5 (19 - 60)
Disease:AML 37/ALL 19/MDS 8/ML 5/Other
leukemias 3
Disease status:CR 62/Others 10
Performance status:PS0 61/PS1 11
Stem cell source:Related 50/Unrelated 22
Participant flow
The first patient was registered in January 2016, and on July 24, 2018, the target number of cases of 70 cases was reached, but there were 5 ineligible cases. The patient registration was continued on the 31st. A total of 77 registered cases were registered from 23 institutions.
Adverse events
The incidence of major grade 3 or higher adverse events up to 30 days after transplantation was stomatitis 25%, nausea and vomiting 24%, diarrhea 9%, infection 13%, and Febrile neutropenia (FN) 18%. Up to 1 year after transplantation, the incidence of cytomegalovirus infection was 5.6%, the incidence of EB virus infection was absent, and the incidence of infection-related death was 4.2%.
Outcome measures
Grade III-IV acute GVHD incidence up to day 100, the primary endpoint, was 1.4% (95%CI; 0.1%-6.7%), which was significantly below the threshold (18%) used to calculate the number of cases.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 24 | 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 | 08 | Month | 11 | Day |
Last modified on
| 2022 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021586
