UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Allogeneic hematopoietic stem cell transplantation for elderly patients
Title of the study (Brief title)	Allo-HSCT for elderly patients
Region	Japan

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

Objectives
Narrative objectives1	To establish the safety of allogeneic hamatopoietic stem cell transplantation for patients who are 60-75 yo.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	survival at day 100 after trasnplantation
Key secondary outcomes	Cumulative incidence of acute and chronic graft-versus-host disease. Disease free and overall survival at 1 year after transplantation

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	Other
Interventions/Control_1	Allogeneic hematopoietic stem cell transplantation was underwent with the below conditioning regimen. (1) Fludarabine 30 mg/m2 x 5 days + Melphalan (80-140) mg/m2 x 1 day +- TBI 2Gy x 2 or (2) Fludarabine 30 mg/m2 x 6 days + Busulfan 0.8 mg/kg x 4/day x 2 days +- TBI 2Gy x 2 Prophylaxis for GVHD is same as our ordinary (non-clinical trial setting) procedure.
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	60 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. For hematologic malignancies, indication for transplantation is equivalent to normal procedures. 2. Patient age 60-75 yo. 3. Written informed consent was achieved.
Key exclusion criteria	(1) Presence of other lethal complications. (2) Severe heart disease (ejection fraction < 40 %, uncontrollable arrhythmia or hypertension). (3) Severe kidney dysfunction (CCr < 30 ml/min). (4) Severe respiratory diease (PaO2 < 70 mmHg, DLCO < 50% or FEV1.0 < 60 %). (5) Severe liver dysfunction (T.Bil > 2.5 mg/dl, cirrhosis). (6) Cases considered to be not suitable in the conference of our department.
Target sample size	50

Research contact person
Name of lead principal investigator	Akira Honda
Organization	University of Tokyo Hospital
Division name	Hematology and Oncology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Email	ahonda-spr@umin.org

Public contact
Name of contact person	Akira Honda
Organization	Univesity of Tokyo Hospital
Division name	Hematology and Oncology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	ahonda-spr@umin.org

Sponsor
Institute	Univesity of Tokyo Hospital, Department of Hematology and Oncology
Institute
Department

Funding Source
Organization	None.
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

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 02 Month 09 Day
Anticipated trial start date	2009 Year 02 Month 09 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	2015 Year 05 Month 30 Day
Last modified on	2018 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020555