UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter phase II study of Tac + mini MTX as GVHD prophylaxis in patients undergoing cord blood transplantation
Title of the study (Brief title)	NJHSG-CBT18
Region	Japan

Condition
Condition	AML,ALL,MDS,ML
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate safety and efficacy of Tac + mini MTX as GVHD prophylaxis in patients undergoing cord blood transplantation
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

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 Following regimen is recommended Flu 180mg/m2 + Bu 6.4-13.2mg/kg + TBI 4Gy or Mel 80mg/m2 2. GVHD prophylaxis Tacrolimus + MTX (day1,3,6: 5mg/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	70 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 or PR b) Myelodysplastic syndrome: more than intermediate as defined by IPSS-R or more than high as defined by WPSS c) Lymphoma: CR or chemosensitive PR 2.Age: 15-70 years old. 3.Patients who have HLA more than 4/6 matched cord blood which have more than 2.0x107/kg of NCC disclosed by Japan Cord Blood Bank Network. 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 has a prior history of allogeneic transplantation. 6.Patients who experienced serious hypersensitivity or anaphylaxis to MTX and who have large amount of pleural effusion or ascites. 7.Patients who are not eligible for this study at the discretion of the investigator.
Target sample size	33

Research contact person
Name of lead principal investigator	Souichi Shiratori
Organization	Hokkaido University Hospital
Division name	Department of Hematology
Address	Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL	011-706-7214
Email	s.shiratori@med.hokudai.ac.jp

Public contact
Name of contact person	Souichi Shiratori
Organization	North Japan Hematology Study Group (NJHSG)
Division name	Comittee of NJHSG
Address	Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL	011-706-7214
Homepage URL
Email	s.shiratori@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)

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	2018 Year 04 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 02 Month 13 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 13 Day
Last modified on	2018 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035703