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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007861
Receipt No. R000009234
Scientific Title Effect of freezing of grafts in HLA 2-3 antigen-mismatched peripheral blood stem cell transplantation
Date of disclosure of the study information 2012/05/07
Last modified on 2014/05/02

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Basic information
Public title Effect of freezing of grafts in HLA 2-3 antigen-mismatched peripheral blood stem cell transplantation
Acronym Freezing grafts in haplo-PBSCT
Scientific Title Effect of freezing of grafts in HLA 2-3 antigen-mismatched peripheral blood stem cell transplantation
Scientific Title:Acronym Freezing grafts in haplo-PBSCT
Region
Japan

Condition
Condition acute myeloid leukemia, acute lymphoid leukemia, chronic myeloid leukemia, chronic lymphoid leukemia, myelodysplastic syndrome, malignant lymphoma, multiple myeloma, myeloproliferative disorder, severe aplastic anemia
Classification by specialty
Hematology and clinical oncology Blood transfusion
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Effects of freezing of grafts to immunological tolerance in the HLA-haploidentical peripheral stem cell transplantation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes dose of steroids on day 100
Key secondary outcomes the incidence of severity of acute GVHD, hematopoietic recovery, engraftment rate, tapering speed of steroids, the incidence of severity of chronic GVHD, survival rate at 1 year, disease-free survival at 1 year, therapy-related mortality at 1 year, the incidence of infection (bacterial, fungal, virus), relapse rate at 2 years, the probability of discontinuation of steroids or immunosuppressants

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Haploidentical transplantation using frozen grafts
Interventions/Control_2 Haploidentical transplantation using non-frozen grafts
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
12 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria A. Disease status
1. Acute myeloid leukemia: second complete remission or later complete remission, induction failure. non-remission status
2. Acute lymphoid leukemia:second complete remission or later complete remission, induction failure. non-remission status, MRD-positive first complete remission in Philadelphia(+) leukemia
3. Myelodysplastic syndrome and myelodysplastic proliferative disorder: intermediate-II or high in International Prognostic Factor Scoring System
4. Malignant lymphoma: patients have to meet the following 2 requirements
1) Histology: the following histology has to be confirmed.
a. precursor B- and T-cell neoplasms: precursor B-lymphoblastic lymphoma, precursor T cell lymphoblastic lymphoma
b. mature B-cell neoplasms: mantle cell lymphoma, diffuse large B-cell lymphoma, mediastinal large B-cell lymphoma, Burkitt lymphoma, intravascular large B-cell lymphoma
c. mature T-cell and NK-cell neoplasms: adult T-cell leukemia/lymphoma, extranodal NK/T-cell lymphoma, enteropathy-type T-cell lymphoma, blastic NK-cell lymphoma, angioimmunoblastic T-cell lymphoma, peripheripheral T-cell lymphoma (unspecified)
d. Hodgkin's lymphoma
2) Disease status:
a. Induction failure
b. Complete or partial remission is not achieved in salvage chemotherapy
c. Second relapse or later stage

B. Donor: patients have to meet the following 3 requirements
1. Patients have no related HLA-matched or 1 antigen-mismatched donors
2. Patients have no HLA-matched unrelated donors or HLA-1 locus mismatched donors in allele type, or urgently need transplantation.
3. Patients have HLA 2-3 antigen-mismatched (in GVH direction) donors.
Key exclusion criteria 1. ECOG performance status scale: 3-5
2. Cardiac dysfunction: ejection fraction < 50%
3. Oxygen saturation < 93%
4. Hepatic dysfunction: Total bilirubin > 2.0 mg/dl or AST > 2.5 times the normal upper limit
5. Renal dysfunction: serum creatinine level > 1.5 times the normal upper limit
Target sample size 60

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, Nishinomiya, Hyogo, Japan
TEL 0798-45-6886
Email ogawah@hyo-med.ac.jp

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

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
Organization
Division
Category of Funding Organization Other
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 兵庫医科大学(兵庫県)

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 07 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 Enrolling by invitation
Date of protocol fixation
2012 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2018 Year 03 Month 01 Day
Date of closure to data entry
2018 Year 03 Month 01 Day
Date trial data considered complete
2018 Year 06 Month 01 Day
Date analysis concluded
2018 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 04 Month 29 Day
Last modified on
2014 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009234

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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