UMIN-CTR Clinical Trial

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
Email	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/
Email	sugitaj@med.hokudai.ac.jp

Sponsor
Institute	North Japan Hematology Study Group (NJHSG)
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019923