UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017744 |
|---|---|
| Receipt number | R000020555 |
| Scientific Title | Allogeneic hematopoietic stem cell transplantation for elderly patients |
| Date of disclosure of the study information | 2015/05/30 |
| Last modified on | 2018/06/01 10:14:16 |
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Basic information
Public title
Allogeneic hematopoietic stem cell transplantation for elderly patients
Acronym
Allo-HSCT for elderly patients
Scientific Title
Allogeneic hematopoietic stem cell transplantation for elderly patients
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Akira Honda |
Organization
University of Tokyo Hospital
Division name
Hematology and Oncology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
ahonda-spr@umin.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Honda |
Organization
Univesity of Tokyo Hospital
Division name
Hematology and Oncology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
ahonda-spr@umin.org
Sponsor or person
Institute
Univesity of Tokyo Hospital,
Department of Hematology and Oncology
Institute
Department
Personal name
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)
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
| 2015 | Year | 05 | Month | 30 | 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
| 2009 | Year | 02 | Month | 09 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020555
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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