UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of conditioning regimen with fludarabine and targeted dose intravenous busulfan for elderly patinets
Acronym	Safety and efficacy of conditioning regimen with fludarabine and targeted dose intravenous busulfan for elderly patinets
Scientific Title	Safety and efficacy of conditioning regimen with fludarabine and targeted dose intravenous busulfan for elderly patinets
Scientific Title:Acronym	Safety and efficacy of conditioning regimen with fludarabine and targeted dose intravenous busulfan for elderly patinets
Region	Japan

Condition
Condition	Acute myeloid leukemia, Myelodysplastic syndrome
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of fludarabine 180mg/m2 and targeted dose of intraveneous busulfan for conditioning regimen for hematopoietic stem cell transplantation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Transplant related death in 100 days post-transplant
Key secondary outcomes	Event free survival (1-year) Non-relapse mortality (1-year, 2-year) Severe nonhematologic toxicity within 28days Engraftment rate at day 100 Fequency of SOS at day 100 frequency of grade2-4 aGVHD frequency of chronic GVHD

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	The dose of busulfan is adjusted to acheieve target total daily AUC of 6000 µmol-min/l
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Acute myeloid leukemia and myelodysplastic syndrome age:from 56 to 69 year-old PS:0-2 No severe organ damages (less than CTCTAE grade 2) Creatinine clearance higher than 50 ml/min/m2 Cardiac ejection fraction: more than 50% No oxygen requirement Aquired written informed consent
Key exclusion criteria	Patient who receieved chemotherapy within 4 weeks prior the day of transplantation. Patients who received gemtuzumab ozogamicin within 3 months prior of transplantation Patients underwent allogeneic transplantation within 1 year HCI-CI higher than 3 points Patients with active double malignancies Patinets with active infection Positivith of HIV-Ab, TPHA, HBs-AB, and HCV-Ab Uncontrolable diabetes and hypertention
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Middle name Last name Chiaki Nakaseko
Organization	Chiba University Hospital
Division name	Department of Hematology
Zip code
Address	1-8-1, Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL	043-225-6502
Email	chiaki-nakaseko@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Middle name Last name Chikako Ohwada
Organization	Chiba Univeersity Hospital
Division name	Department of Hematology
Zip code
Address	1-8-1, Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL	+81-43-225-6502
Homepage URL
Email	chikako_ohwada@faculty.chiba-u.jp

Sponsor
Institute	Chiba University Hospital, Department of Hematology
Institute
Department

Funding Source
Organization	Chiba University Hospital, Department of Hematology
Organization
Division
Category of Funding Organization	Self funding
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	2013 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	Completed
Date of protocol fixation	2012 Year 10 Month 01 Day
Date of IRB	2012 Year 09 Month 01 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry	2016 Year 09 Month 30 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2013 Year 04 Month 19 Day
Last modified on	2022 Year 11 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012328