Unique ID issued by UMIN | UMIN000029947 |
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Receipt number | R000034144 |
Scientific Title | A randomized control trial of conditioning regimen of cord blood transplantation for adult myeloid malignancies comparing CA/CY/TBI with vs without G-CSF priming |
Date of disclosure of the study information | 2018/02/01 |
Last modified on | 2022/05/30 17:45:12 |
A randomized control trial of conditioning regimen of cord blood transplantation for adult myeloid malignancies comparing CA/CY/TBI with vs without G-CSF priming
CBT-P3 study comparing CA/CY/TBI with vs without G-CSF priming
A randomized control trial of conditioning regimen of cord blood transplantation for adult myeloid malignancies comparing CA/CY/TBI with vs without G-CSF priming
CBT-P3 study comparing CA/CY/TBI with vs without G-CSF priming
Japan |
Myelogenous Hematological Malignancies
Hematology and clinical oncology |
Malignancy
NO
To investigate the efficacy of granulocyte-colony-stimulating factor use with conditioning regimen for umbilical cord blood transplantation for adult myelogenous hematological malignancy patient. Conditioning regimen consists of a combination of cytarabine, cyclophosphamide, and total body irradiation.
Efficacy
Confirmatory
Phase III
2-year disease-free survival
1) Time to hematopoietic recovery
2) Engraftment rate
3) Treatment-related toxicity until day 28
4) Mucosal toxicity grade until day 42 (maximum grade and incidence)
5) Maximum dose of narcotic drug per day until day 42
6) Incidence and severity of acute GVHD
7) Incidence and severity of chronic GVHD
8) Treatment-related mortality at day 100 and 2 years after transplantation
9) Relapse rate at 2 years after transplantation
10) Overall survival (OS) at 2 years after transplantation
11) Incidence of infectious event (causative bacteria or other microorganisms, site of infection, day of onset, frequency)
12) Causes of deaths
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
To add G-CSF priming to the conditioning regimen concomittantly with two days of Ara-C.
Not to add G-CSF to the conditioning regimen.
16 | years-old | <= |
55 | years-old | >= |
Male and Female
1.First stem cell transplantation including autologous or allogeneic.
2.Hematological disease listed below.
-Acute myelogenous leukemia
-Myelodysplastic syndrome, RAEB-1 or RAEB-2. Either intemediate-II or high in IPSS. High or very-high in WPSS. Relapsed after CR.
3.Obtained informed consent
4.Performance status 0,1,2
5.appropriate cord blood is available
6.appropriate organ function
1.HBs antigen positive
2.HCV antibody positive
3.HIV antibody positive
4 Donor-specific anti-HLA antibody positive
5.Use of gemtuzumab ozogamicin within 6 months before transplantation
6.During pregnant or breast-feeding
7. Uncontrollable psychiatric disorder
8. Uncontrollable infection
9. Allergy for any drug used in the conditioning regimen or GVHD-prophylaxis
10.Considered to be unfit for the study enrollment by the physician
160
1st name | Seitaro |
Middle name | |
Last name | Terakura |
Nagoya University Hospital
Deapartment of Hematology
466-8560
65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan
052-744-2145
tseit@med.nagoya-u.ac.jp
1st name | Seitaro |
Middle name | |
Last name | Terakura |
Nagoya University Hospital
Department of Hematology
466-8560
65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan
052-744-2145
tseit@med.nagoya-u.ac.jp
Japan Agency for Medical Research and Development
Japan Agency for Medical Research and Development
Japanese Governmental office
Nagoya University Certified Review Board
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
052-744-2947
ethics@med.nagoya-u.ac.jp
YES
jRCTs041180059
Ministry of Health, Labour and Welfare
2018 | Year | 02 | Month | 01 | Day |
Unpublished
No longer recruiting
2017 | Year | 11 | Month | 15 | Day |
2018 | Year | 01 | Month | 11 | Day |
2018 | Year | 01 | Month | 15 | Day |
2024 | Year | 12 | Month | 31 | Day |
2017 | Year | 11 | Month | 13 | Day |
2022 | Year | 05 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034144
Research Plan | |
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Registered date | File name |
2023/05/19 | CBT-P3_protocol_3.1.1_20221219.docx |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |