UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007913 |
|---|---|
| Receipt number | R000009310 |
| Scientific Title | HLA-mismatched allogeneic hematopoietic stem cell transplantation for advanced hematological malignancy using low-dose alemtuzumab |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2019/11/15 00:11:18 |
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Basic information
Public title
HLA-mismatched allogeneic hematopoietic stem cell transplantation for advanced hematological malignancy using low-dose alemtuzumab
Acronym
HLA-mismatched HSCT using low-dose alemtuzumab
Scientific Title
HLA-mismatched allogeneic hematopoietic stem cell transplantation for advanced hematological malignancy using low-dose alemtuzumab
Scientific Title:Acronym
HLA-mismatched HSCT using low-dose alemtuzumab
Region
| Japan |
Condition
Condition
advanced hematological malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of HLA-mismatched allogeneic HSCT for advanced hematological malignancy using low-dose alemtuzumab
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival rate at 60 days after transplantation with the engraftment of donor cells and without grade III-IV GVHD
Key secondary outcomes
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
Conditioning regimen: Patients who are intolerable to conventional conditioning regimen due to either higher age (55>=), previous ASCT, organ dysfunction, or active infection will receive regimen 2-1 or 2-2. The other patients will receive regimen 1.
Regimen 1
Cyclophosphamide
60mg/kg/day iv. for 2 days
TBI
2Gy twice daily for 3 days
Alemtuzumab
0.25mg/kg/day iv. day-4,-3
(Maximum dose: 15mg/body/day for 2 days)
Regime 2-1
Fludarabine
25mg/m2/day iv. for 5 days
Melphalan
40mg/m2/day iv. for 2 days
Alemtuzumab
0.25mg/kg/day iv. day-4,-3
(Maximum dose: 15mg/body/day for 2 days)
Regimen 2-2
Fludarabine
30mg/m2/day iv. for 6 days
Busulfan
3.2mg/kg/day iv. for 2-4 days
TBI
2Gy twice daily for 1 day
Alemtuzumab
0.25mg/kg/day iv. day-4,-3
(Maximum dose: 15mg/body/day for 2 days)
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria
1.Patients who do not have an available HLA-matched or one locus-mismatched related donor.
2.Patients who have a two- or three-locus-mismatched haploidentical related donor in good condition. (This donor should precede an HLA-matched or one locus-mismatched related donor accoridng to the disease status.)
3.Patients who do not have an HLA-matched or one allele-mismatched unrelated donor, or patients whose disease status preclude time-consuming donor coordination.
4.Patients with high-risk acute leukemia, advanced CML, refractory malignant lymphoma, advanced MDS, acute or lymphoma type ATLL, or refractory severe aplastic anemia.
5.Patients who are 20 to 65 years old
6.Patients in performance status of 0 or 1.
7.Patients whose major organ functions are preserved.
Key exclusion criteria
Exclusion criteria
1.Patients with poorly controlled active infection.
2.Patients with coexistence of malignancy.
3.Patients who are pregnant or nursing.
4.Patients with serious mental disorder.
5.Patients with HIV antibody positive.
6.Patients who are allergic to drugs used in conditioning regimen or GVHD prophylaxis.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Kanda |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of Hematology
Zip code
330-8503
Address
1-847 Amanuma, Omiya-ku, Saitama-city, Saitama 330-8503, Japan
TEL
0486472111
shinichikako@asahi-net.email.ne.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Kako |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of Hematology
Zip code
330-8503
Address
1-847 Amanuma, Omiya-ku, Saitama-city, Saitama 330-8503, Japan
TEL
0486472111
Homepage URL
shinichikako@asahi-net.email.ne.jp
Sponsor or person
Institute
Division of Hematology, Saitama Medical Center, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid from the Ministry of Health, Labor and Welfare of Japan.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
institutional review board of Jichi Medical University Saitama Medical Center
Address
1-847 Amanuma, Omiya-ku, Saitama-city, Saitama 330-8503, Japan
Tel
048-647-2111
yanaiakr@jichi.ac.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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000009310
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/ejh.13204?af=R
Number of participants that the trial has enrolled
14
Results
The primary outcome
measure was the survival rate with the engraftment of donor cells and without
grade III-IV acute graft-vs-host disease (GVHD) at 60 days after transplantation.The primary outcome measure was achieved in 86% of the patients.
Results date posted
| 2019 | Year | 11 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
adult patients with advanced hematological malignancy
Participant flow
one-arm study; patients participated from a single institution
Adverse events
Non-relapse death was observed in three patients,
and all of them had a history of previous allogeneic HSCT.
Outcome measures
the survival rate with the engraftment of donor cells and without
grade III-IV acute graft-vs-host disease (GVHD) at 60 days after transplantation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 09 | Day |
Last modified on
| 2019 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009310
