UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019089 |
|---|---|
| Receipt number | R000021182 |
| Scientific Title | A study of haploidentical transplantation with post-transplant cyclophosphamide |
| Date of disclosure of the study information | 2015/09/25 |
| Last modified on | 2015/09/22 10:44:35 |
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Basic information
Public title
A study of haploidentical transplantation with post-transplant cyclophosphamide
Acronym
A study of haploidentical transplantation with post-transplant cyclophosphamide
Scientific Title
A study of haploidentical transplantation with post-transplant cyclophosphamide
Scientific Title:Acronym
A study of haploidentical transplantation with post-transplant cyclophosphamide
Region
| Japan |
Condition
Condition
AML,ALL,MDS,NHL,MM,CML
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and efficacy of HLA haploidentical hematopoietic stem cell transplantation using post transplant cyclophosphamide.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
treatment related mortality within 100days
Key secondary outcomes
1. overall survival, event free survival, relapse rate at 100 days
2. overall survival, event free survival, relapse rate at 1 year
3. neutrophilans platlet engraftment
4. engraftment failure
5. complete chimerism
6. acute GVHD
7. chronic GVHD
8. infectious event
9. grade 3-4 toxicity within 100 days
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
GVHD prophilaxis Cyclophosphamide 50mg/kg iv day3,4(or 5)
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 have hematologic malignancies and who are eligible for allogenic transplantation.
2. Age 15-70 years
3. 2nd CR or subsequent CR, nonCR. 1st CR as defined at least one of folloing: a) Acute lymphoblastic leukemia Intermediate or Poor risk as defined by NCCN guidelines
b) Acute Myelogenous Leukemia
Greater than 1 cycle of induction therapy required to achieve remission, Intedmediate or High risk as defined by NCCN guidelines
Monosomal karyotype ckit mutations with t(8;21), inv(16), t(16;16) t(7;11)(p15;p15)
Preceding myelodysplastic syndrome
c) Myelodysplastic syndrome
high, very high as defined by WHO classification-based Prognostic Scoring System
Patients who have receive ten units or more platelet transfusions per week, or two units or more RBC transfusions per month.
4. Patients who have no HLA-matched or 7/8 matched related donor.
5. Patients who have no HLA-matched or 7/8 matched unrelated donor.
6. Patients who given written informed consent to participate in the study.
Key exclusion criteria
1. Patients who are positive for HBs antigen, HCV antibody, or HIV antibody.
2. Patients with active other malignancies.
3. Women who are pregnant, of childbearing potential, or lactating.
4. Patients who experienced serious hypersensitivity or anaphylaxis to cyclophosphamide.
5. patients who are not eligble for this study at the discretion of the investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kinya Ohata |
Organization
Kanazawa University Hospital
Division name
Department of Hematology
Zip code
Address
13-1, takaramachi, kanazawa, ishikawa
TEL
076-265-2275
ohata.521222@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kinya Ohata |
Organization
Kanazawa University Hospital
Division name
Department of Hematology
Zip code
Address
13-1, takaramachi, kanazawa, ishikawa
TEL
076-265-2275
Homepage URL
ohata.521222@gmail.com
Sponsor or person
Institute
Department of Hematology, Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
non
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 25 | 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
| 2013 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 27 | 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 | 09 | Month | 22 | Day |
Last modified on
| 2015 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021182
