UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007861 |
|---|---|
| Receipt number | 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 09:49:14 |
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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
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
ogawah@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009234
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