UMIN-CTR Clinical Trial

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-
Email	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
Email	jsct-office@umin.ac.jp

Sponsor
Institute	JSCT
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021586