UMIN-CTR Clinical Trial

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030308
Receipt No. R000034613
Scientific Title A prospective feasibility study of cord blood transplant using once daily intravenous busulfan and fludarabine plus melphalan as conditioning regimen
Date of disclosure of the study information 2017/12/09
Last modified on 2019/09/17 (Ver. 4)

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Basic information
Public title A prospective feasibility study of cord blood transplant using once daily intravenous busulfan and fludarabine plus melphalan as conditioning regimen
Acronym FluBuOnceDaily plus Mel for CBT
Scientific Title A prospective feasibility study of cord blood transplant using once daily intravenous busulfan and fludarabine plus melphalan as conditioning regimen
Scientific Title:Acronym FluBuOnceDaily plus Mel for CBT
Region
Japan

Condition
Condition Hematological malignancy
Classification by specialty
Hematology and clinical oncology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety of once daily intravenous busulfan in combination with melphalan in the setting of CBT
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Engraftment rate
Key secondary outcomes (1) non-relapse mortality rate at 100 days after CBT
(2) SOS rate at 100 days after CBT
(3) 1-year overall survival and relapse rates

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 once daily intravenous busulfan in combination with melphalan in the setting of CBT
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
18 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria (1) Age 18 years or older
less than 70 years
(2) patients with a hematological malignancy
who are eligible for CBT
(3) patients who will receive CBT
(4) ECOG PS 0 or 1
(5) patients with consent to this study
Key exclusion criteria (1) patients with organ dysfunction
(lung, renal, liver, heart)
(2) patients who are expected not to survive 100 days or longer
(3) patients with another active cancer
(4) pregnant or breast-feeding
(5) patients with mental disorder
(6) the physician consider inappropriate for this study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Shigeo
Middle name
Last name Fuji
Organization Osaka International Cancer Institute
Division name Department of Hematology
Zip code 5418567
Address 3-1-69, Otemae, Chuo-ku, Osaka-city, Osaka
TEL 06-6945-1181
Email fujishige1231@gmail.com

Public contact
Name of contact person
1st name Shigeo
Middle name
Last name Fuji
Organization Osaka International Cancer Institute
Division name Department of Hematology
Zip code 5418567
Address 3-1-69, Otemae, Chuo-ku, Osaka-city, Osaka
TEL 06-6945-1181
Homepage URL
Email fujishige1231@gmail.com

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization Osaka International Cancer Institute
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka International Cancer Institute, Clinical Research Center
Address 3-1-69, Otemae, Chuo-ku
Tel 06-6945-1181
Email rinri01@opho.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 大阪国際がんセンター

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 09 Day

Related information
URL releasing protocol NA
Publication of results Unpublished

Result
URL related to results and publications NA
Number of participants that the trial has enrolled 0
Results 
Because the schedule of treatment in this study was approved by the government, we decided to stop this trial.
Results date posted
2019 Year 09 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
NA
Participant flow 
NA
Adverse events 
NA
Outcome measures 
NA
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2017 Year 12 Month 08 Day
Date of IRB
2017 Year 12 Month 08 Day
Anticipated trial start date
2017 Year 12 Month 08 Day
Last follow-up date
2018 Year 07 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 08 Day
Last modified on
2019 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034613