UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027789 |
|---|---|
| Receipt number | R000031272 |
| Scientific Title | Multi-center non-randomized open trial to evaluate the efficacy of azacitidine followed by allo-HSCT for TP53(+) MDS. |
| Date of disclosure of the study information | 2017/06/20 |
| Last modified on | 2022/06/20 09:17:28 |
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Basic information
Public title
Multi-center non-randomized open trial to evaluate the efficacy of azacitidine followed by allo-HSCT for TP53(+) MDS.
Acronym
REPTAT trial
Scientific Title
Multi-center non-randomized open trial to evaluate the efficacy of azacitidine followed by allo-HSCT for TP53(+) MDS.
Scientific Title:Acronym
REPTAT trial
Region
| Japan |
Condition
Condition
myelodysplastic syndromes
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluated the combined treatment of azacitidine followed by allogeneic HSCT for intractable TP53-positive myelodysplastic syndromes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2-year OS after allogeneic hematopoietic stem cell transplantation.
Key secondary outcomes
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 | Maneuver |
Interventions/Control_1
azacitidine treatment followed by allogeneic HSCT
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) MDS or MDS/MPN(CMML) according to WHO classification (4th) or MDS (RAEB-t) according to FAB classification.
(2) Age between 16 and 69.
(3) No history of azacitidine treatment OR on azacitidine treatment and fulfills all of the following conditions;
*On azacitidine treatment
*Total interruption period of azacitidine <3 months.
*Efficacy of azacitidine be SD or above.
*Specimen of bone marrow and/or peripheral blood is available for genetic study.
(4) Indication for allogeneic HSCT, and the patient has the will.
(5) ECOG Performance status (PS) 0-2
(6) Sufficient organ function to receive therapy (fulfill all of the below conditions)
*T.Bil<2.0mg/dL
*Cre<2.0mg/dL
*GOT/GPT< 3x ULN
*No serious heart or lung diseases.
(7) Provide written informed consent to join the study on his/her free-will.
Key exclusion criteria
(1) Previous history of allo-HSCT.
(2) Obviously refractory to azacitidine, or
planning allo-HSCT for disease progression after azacitidine treatment.
(3) Active comorbid malignancy (less than 5 years after cure) except for myeloid malignancies that are assumed to be associated with MDS development.
(4) Have uncontrollable infections.
(5) Have psychiatric disorders requiring major tranquilizers.
(6) During pregnancy or suspected pregnancy.
(7) Positive for either HBs-Ag, HCV-Ab, HIV-Ab.
(8) Assumed inappropriate to register the study by the attending doctors.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yasuhito |
| Middle name | |
| Last name | Nannya |
Organization
Kyoto University
Division name
Dep. of Pathol. & Tumor Biol.
Zip code
6068501
Address
Sakyo-ku
TEL
+81757539285
ynanya-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yasuito |
| Middle name | |
| Last name | Nannya |
Organization
Kyoto University
Division name
Dep. of Pathol. & Tumor Biol.
Zip code
6068501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto City
TEL
075-753-9285
Homepage URL
ynanya-tky@umin.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
| 2017 | Year | 06 | Month | 20 | 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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 16 | Day |
Last modified on
| 2022 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031272
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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