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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007913
Receipt No. 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

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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
Email 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
Email shinichikako@asahi-net.email.ne.jp

Sponsor
Institute Division of Hematology, Saitama Medical Center, Jichi Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009310

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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