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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000253
Receipt No. R000000319
Scientific Title A phase I/II trial of HLA haploidentical peripheral blood stem cell transplantation following reduced-intensity conditioning
Date of disclosure of the study information 2005/10/01
Last modified on 2012/03/30

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Basic information
Public title A phase I/II trial of HLA haploidentical peripheral blood stem cell transplantation following reduced-intensity conditioning
Acronym A phase I/II trial of HLA haploidentical minitransplantation
Scientific Title A phase I/II trial of HLA haploidentical peripheral blood stem cell transplantation following reduced-intensity conditioning
Scientific Title:Acronym A phase I/II trial of HLA haploidentical minitransplantation
Region
Japan

Condition
Condition Chronic myeloid leukemia, Acute myeloid leukemia, Acute lymphoid leukemia, Myelodysplastic syndrome, Malignant lymphoma
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 haploidentical peripheral blood stem cell transplantation following redeced-intensity conditioning for the patients with refractory hematological malignancies.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Neutrophil engraftment within 35 days after transplantation (Phase I)
Overall survival at day 100 after transplantion (Phase II)
Key secondary outcomes Incidence and severity of acute GVHD
Incidence and severity of chonic GVHD
Overall survival at 1 year after transplantation
Diase free survival at 1 year after transplantation
Treatment related mortality at 1 year after transplantation
Incidence and severity of infectious disease after transplantation
Immune reconstitution after transplantation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 HLA haploidentical peripheral blood stem cell transplantation following reduced-intensity conditioning
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
18 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria 1) CML(2nd or later CP, AP, BC or relapse in non-CP state after allogeneic stem cell transplantation), AML(2nd or later CR, primary refractory or non-CR), ALL(2nd or later CR, primary refractory, non-CR or 1st CR in patients with Ph+ALL who could not achieve molecular remission), MDS/CMML(Int-II or high of the International Prognostic Scoring System, or relapse), Maglignant lymphoma (chemorefractory aggressive lymphoma)
2) Patients aged between 35 and 55 years. Patients aged between 18 and 35 years who are not eligible for myeloablative conditioning. 3) Written informed consent.
4) Unavailability of HLA-matched or -one antigen mismatched-related donor. Unavailability of HLA-matched or one allele mismatched-unrelated donor or needs urgent transplantation.
5) Availability of HLA-haploidentical family donor.
6) Performance status 0 or 1
7) Sufficient organ function
Key exclusion criteria 1) Allergy for the agents used in conditioning or GVHD prophylaxis
2) Positivity for HBs antigen and/or HIV antibody
3) Active lesions in CNS
4) Active infections
5) Patients who are considered as inappropriate with other reasons
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Ogawa
Organization Hyogo College of Medicine
Division name Division of Hematology, Department of Internal Medicine
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6886
Email

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Yoshihara
Organization Hyogo College of Medicine
Division name Division of Hematology, Department of Internal Medicine
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6886
Homepage URL
Email haplo@hyo-med.ac.jp

Sponsor
Institute Health and Labour Sciences Research Grants, Research on Human Genome, Tissue Engineering, Ministry of Health, Labour and Welfare
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)

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

Other administrative information
Date of disclosure of the study information
2005 Year 10 Month 01 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 No longer recruiting
Date of protocol fixation
2005 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 10 Month 01 Day
Last follow-up date
2013 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 09 Month 30 Day
Last modified on
2012 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000319

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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