Unique ID issued by UMIN | UMIN000027789 |
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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 |
Multi-center non-randomized open trial to evaluate the efficacy of azacitidine followed by allo-HSCT for TP53(+) MDS.
REPTAT trial
Multi-center non-randomized open trial to evaluate the efficacy of azacitidine followed by allo-HSCT for TP53(+) MDS.
REPTAT trial
Japan |
myelodysplastic syndromes
Hematology and clinical oncology |
Malignancy
YES
To evaluated the combined treatment of azacitidine followed by allogeneic HSCT for intractable TP53-positive myelodysplastic syndromes.
Safety,Efficacy
2-year OS after allogeneic hematopoietic stem cell transplantation.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Maneuver |
azacitidine treatment followed by allogeneic HSCT
16 | years-old | <= |
70 | years-old | > |
Male and Female
(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.
(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.
24
1st name | Yasuhito |
Middle name | |
Last name | Nannya |
Kyoto University
Dep. of Pathol. & Tumor Biol.
6068501
Sakyo-ku
+81757539285
ynanya-tky@umin.ac.jp
1st name | Yasuito |
Middle name | |
Last name | Nannya |
Kyoto University
Dep. of Pathol. & Tumor Biol.
6068501
Yoshida Konoe-cho, Sakyo-ku, Kyoto City
075-753-9285
ynanya-tky@umin.ac.jp
Japan Agency for Medical Research and Development
Japan Agency for Medical Research and Development
Japanese Governmental office
Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital Ethics Committee
Yoshida-Konoe-cho, Sakyo-ku
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
NO
2017 | Year | 06 | Month | 20 | Day |
Unpublished
Completed
2017 | Year | 09 | Month | 15 | Day |
2017 | Year | 09 | Month | 14 | Day |
2017 | Year | 10 | Month | 18 | Day |
2025 | Year | 09 | Month | 30 | Day |
2017 | Year | 06 | Month | 16 | Day |
2022 | Year | 06 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031272
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