UMIN-CTR Clinical Trial

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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