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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018298
Receipt No. R000021179
Scientific Title HLA-mismatched allogeneic hematopoietic stem cell transplantation for high-risk advanced hematological disease with the adjustments of immunosuppressants and low-dose alemtuzumab.
Date of disclosure of the study information 2015/07/13
Last modified on 2019/01/14

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Basic information
Public title HLA-mismatched allogeneic hematopoietic stem cell transplantation for high-risk advanced hematological disease with the adjustments of immunosuppressants and low-dose alemtuzumab.
Acronym HLA-mismatched HSCT for high-risk hematological disease with adjusted immunosuppressabts and low-dose alemtuzumab
Scientific Title HLA-mismatched allogeneic hematopoietic stem cell transplantation for high-risk advanced hematological disease with the adjustments of immunosuppressants and low-dose alemtuzumab.
Scientific Title:Acronym HLA-mismatched HSCT for high-risk hematological disease with adjusted immunosuppressabts and low-dose alemtuzumab
Region
Japan

Condition
Condition High-risk advanced hematological disease(leukemia and malignant lymphoma in non-remission, MDS with more than 20% of blast, and relapsed disease after allogeneic transplantation)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of HLA-mismatched allogeneic HSCT for High-risk advanced hematological malignancy with adjusted immunosuppressants and low-dose alemtuzumab
Basic objectives2 Safety,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.(Mainly, regimen 2-1 will be selected in patients with lymphoid malignancy and regimen 2-2 will be selected in patients with myeloid malignancy.) In patients who were not eligible for TBI-containing regimen, regimen 2-3 may be selected. 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)
*Cytarabine 2g/m2 twice/day iv. for 2-3 days
or etoposide 15ng/kg/day iv. for 2 days may be added.
*Cyclophosphamide may be replaced with fludarabine 30mg/m2/day iv. for 4 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 once or twice daily for 1 day
Alemtuzumab
0.25mg/kg/day iv. day-4,-3
(Maximum dose: 15mg/body/day for 2 days)

Regimen 2-3
Fludarabine
30mg/m2/day iv. for 6 days
Busulfan
3.2mg/kg/day iv. for 4 days
Melphalan
80-140mg/m2/day iv. for 1 days
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
70 years-old >=
Gender Male and Female
Key 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 advanced hematological disease. Leukemia and malignant lymphoma in non-remission, MDS with more than 20% of blast, and relapsed disease after allogeneic transplantation are included in high-risk group.
5.Patients who are 16 to 70 years old
6.Patients in performance status of 0 or 1.
7.Patients whose major organ functions are preserved.
Key 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 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinobu Kanda
Organization Saitama Medical Center, Jichi Medical University
Division name Division of Hematology
Zip code
Address 1-847 Amanuma, Omiya-ku, Saitama-city, Saitama 330-8503, Japan
TEL +81-48-647-2111
Email ycanda-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Kako
Organization Saitama Medical Center, Jichi Medical University
Division name Division of Hematology
Zip code
Address 1-847 Amanuma, Omiya-ku, Saitama-city, Saitama 330-8503, Japan
TEL +81-48-647-2111
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
Address
Tel
Email

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 自治医科大学附属さいたま医療センター(埼玉県)
自治医科大学附属病院(栃木県)

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 13 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 Open public recruiting
Date of protocol fixation
2015 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 14 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 07 Month 13 Day
Last modified on
2019 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021179

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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