UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031269 |
|---|---|
| Receipt number | R000035703 |
| Scientific Title | A multicenter phase II study of Tac + mini MTX as GVHD prophylaxis in patients undergoing cord blood transplantation |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2018/03/31 13:57:07 |
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Basic information
Public title
A multicenter phase II study of Tac + mini MTX as GVHD prophylaxis in patients undergoing cord blood transplantation
Acronym
NJHSG-CBT18
Scientific Title
A multicenter phase II study of Tac + mini MTX as GVHD prophylaxis in patients undergoing cord blood transplantation
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Souichi Shiratori |
Organization
Hokkaido University Hospital
Division name
Department of Hematology
Zip code
Address
Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
011-706-7214
s.shiratori@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Souichi Shiratori |
Organization
North Japan Hematology Study Group (NJHSG)
Division name
Comittee of NJHSG
Zip code
Address
Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
011-706-7214
Homepage URL
s.shiratori@med.hokudai.ac.jp
Sponsor or person
Institute
North Japan Hematology Study Group (NJHSG)
Institute
Department
Personal name
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
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 |
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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 13 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035703
