UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017170
Receipt No. 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 2016/04/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Akio Shigematsu
Organization Hokkaido University Hospital
Division name Department of Hematology
Zip code
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
Middle name
Last name Junichi Sugita
Organization Hokkaido University Hospital
Division name Department of Hematology
Zip code
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
Address
Tel
Email

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
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
2013 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
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
2016 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019923

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.