UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of allogeneic hematopoietic stem cell transplantation for refractory hematological malignancies with plerixafor-combined myeloablative conditioning
Title of the study (Brief title)	Allogeneic hematopoietic stem cell transplantation with plerixafor-combined conditioning
Region	Japan

Condition
Condition	acute leukemia, myelodysplastic syndrome, chronic myelogenous leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety and efficacy of allogeneic hematopoietic stem cell transplantation with plerixafor-combined myeloablative conditiong for refractory hematological malignancies
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse events within 28 days after transplantation
Key secondary outcomes	1) neutrophil engraftment 2) red cell and platelet engraftment 3) non-relapse mortality with 28 days after transplantation 4) 1-year overall and non-relapse survivial 5) 1-year relapse rate 6) acute and chronic GVHD 7) Infectous complications

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	Allogeneic hematopoietic stem cell transplantation with plerixafor-combined myeloablative conditioning
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	20 years-old <=
Age-upper limit	55 years-old >
Gender	Male and Female
Key inclusion criteria	1) Acute myeloid or lymphoblastic leukemia not in remission or with high-risk cytogenetics 2) Chronic myelogenous leukemia in accelerated phase, blastic crisis, and second chronic phase 3) myelodysplastic syndrome with 10% or greater blast in bone marrow or 5% or greater in peripheral blood
Key exclusion criteria	Moderate or severe dysfunction in major organs
Target sample size	12

Research contact person
Name of lead principal investigator	Takehiko Mori
Organization	Keio University School of Medicine
Division name	Division of Hematology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	tmori@a3.keio.jp

Public contact
Name of contact person	Takehiko Mori
Organization	Keio University School of Medicine
Division name	Division of Hematology
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	tmori@a3.keio.jp

Sponsor
Institute	Division of Hematology Keio University School of Medicine
Institute
Department

Funding Source
Organization	Division of Hematology Keio University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 29 Day
Anticipated trial start date	2012 Year 12 Month 05 Day
Last follow-up date	2015 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2015 Year 12 Month 31 Day
Date analysis concluded	2018 Year 02 Month 28 Day

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

Management information
Registered date	2012 Year 12 Month 05 Day
Last modified on	2019 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011147