Unique ID issued by UMIN | UMIN000008470 |
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Receipt number | R000009626 |
Scientific Title | Post remission therapy with arsenic trioxide and gemtuzumab ozogamicin in acute promylocytic leukemia, a phase II study (JALSG APL212 Study) |
Date of disclosure of the study information | 2012/07/19 |
Last modified on | 2023/01/26 15:20:50 |
Post remission therapy with arsenic trioxide and gemtuzumab ozogamicin in acute promylocytic leukemia, a phase II study (JALSG APL212 Study)
Post remission therapy with arsenic trioxide and gemtuzumab ozogamicin in acute promylocytic leukemia (JALSG APL212)
Post remission therapy with arsenic trioxide and gemtuzumab ozogamicin in acute promylocytic leukemia, a phase II study (JALSG APL212 Study)
Post remission therapy with arsenic trioxide and gemtuzumab ozogamicin in acute promylocytic leukemia (JALSG APL212)
Japan |
Adult acute promylocytic leukemia
Hematology and clinical oncology |
Malignancy
YES
Investigate whether post remission therapy with arsenic trioxide (ATO), gemtuzumab ozogamicin (GO) and tamibarotene (Am80), which are more specific and less toxic for acute promylocytic leukemia (APL), will improve the outcome or not.
Safety,Efficacy
Exploratory
Phase II
3-year event free survival (EFS)
1. Complete remission rate (CR)
2. 3- and 5-year disease free survival (DFS)of patients in CR
3. 3- and 5-year overall survival (OS)
4. 5-year event free survival (EFS)
5. CR, DFS and OS of each group
6. Adverse events.
7. Analyses of PML-RARA isoform, FLT3/ITD mutation, CD56 expression, additional chromosome abnormality and their effects on prognosis
8. Coagulation and fibrinolysis factors, and their effects on prognosis.
9. Determination of genetic abnormality and polymorphism of by genome and exome analyses for treatment related adverse events including APL differentiation syndrome.
10. Determination of genetic abnormality and polymorphism of by genome and exome analyses for the efficacy of treatment.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
all-trans retinoic acid
idarubicin
cytarabine
arsenic trioxide
daunorubicin
gemtuzumab ozogamicin
tamibarotene (Am80)
15 | years-old | <= |
64 | years-old | >= |
Male and Female
1. Newly diagnosed APL (FAB: M3 or M3v)
2. Performance status (ECOG): 0-2
3. Adequate cardiac, pulmonary, hepatic and renal function
4. Written informed consent
1. History of myelodysplastic syndrome
2. Atypical acute leukemia
3. Uncontrollable infection
4. Severe co-morbidity
5. Positive anti-HIV antibody, HBs antigen or anti-HCV antibody
6. Other active neoplasm
7. Pregnant and/or lactating woman
8. Psychological disorders
9. Patients who have a difficulty to enter the study.
222
1st name | Akihiro |
Middle name | |
Last name | Takeshita |
Hamamatsu University School of Medicine
Internal Medicine
431-3192
1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
(+81)-53-433-4993
akihirot@hama-med.ac.jp
1st name | Akihiro |
Middle name | |
Last name | Takeshita |
Hamamatsu University School of Medicine
Internal Medicine
431-3192
1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
(+81)-53-433-4993
http://www.jalsg.jp/
akihirot@hama-med.ac.jp
the Japan Adult Leukemia Study Group (JALSG)
Ministry of Health, Labor and Welfare
Other
Japan
the Nonprofit Supportive Organization for Cooperative Study on Adult Leukemia Treatment
Clinical Research Review Board of Hamamatsu University School of Medicine
1-20-1 Handayama, Hamamatsu, Higashi-ku, 431-3192, Japan
(+81)-53-435-2676
kenkyou@hama-med.ac.jp
NO
2012 | Year | 07 | Month | 19 | Day |
Unpublished
Open public recruiting
2012 | Year | 05 | Month | 30 | Day |
2012 | Year | 05 | Month | 30 | Day |
2012 | Year | 07 | Month | 01 | Day |
2021 | Year | 03 | Month | 31 | Day |
2021 | Year | 12 | Month | 31 | Day |
2022 | Year | 01 | Month | 28 | Day |
2023 | Year | 03 | Month | 31 | Day |
2012 | Year | 07 | Month | 19 | Day |
2023 | Year | 01 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009626
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