試験ID UMIN000008471
最終情報更新日：2026年6月23日
65歳以上の急性前骨髄球性白血病に対する亜ヒ酸による地固め療法 -第Ⅱ相臨床試験- JALSG APL212G
基本情報
| 試験ID | UMIN000008471 | |
|---|---|---|
| 研究名称 / Scientific Title（Acronym） | 65歳以上の急性前骨髄球性白血病に対する亜ヒ酸による地固め療法 -第Ⅱ相臨床試験- JALSG APL212G | Post remission therapy including arsenic trioxide against acute promylocytic leukemia over 65 years old, Phase II Clinical Study (JALSG APL212G study) |
| 平易な研究名称 / Public Title（Acronym） | Post remission therapy including arsenic trioxide against acute promylocytic leukemia over 65 years old, Phase II Clinical Study (JALSG APL212G study) | |
| 試験進捗状況/Recruitment status | 試験中止 | Complete: follow-up complete |
| 登録日時 | 2012年7月19日 | |
| 最終情報更新日 | 2026年6月23日 | |
| 試験開始日（予定日） | ||
| 試験終了日（予定日） | ||
| 組入れ開始日 / Date of first enrollment | ||
試験概要
| 試験実施地域 / Region | 日本 | Japan |
|---|---|---|
| 実施都道府県 | ||
| 目標症例数/Target sample size | 63 | |
| 対象疾患 / Health condition(s) or Problem(s) studied | 成人急性前骨髄球性白血病 | Adult acute promylocytic leukemia |
| 試験のタイプ / Study type | 介入 | Interventional |
| 試験デザイン / Study design | ||
| ランダム化 / Randomization | ||
| 介入1 | 全トランス型レチノイン酸 イダルビシン 亜ヒ酸 タミバロテン | |
| 主要評価項目 / Primary outcomes | 3年無イベント生存率 | 3-year event free survival (EFS) |
| 副次評価項目 / Secondary outcomes | 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. Quality of life 10. Determination of genetic abnormality and polymorphism of by genome and exome analyses for treatment related adverse events including APL differentiation syndrome. 11. Determination of genetic abnormality and polymorphism of by genome and exome analyses for the efficacy of treatment. | |
適格性
| 年齢（下限）/ Age minimum | 65歳以上 | 65years-old |
|---|---|---|
| 年齢（上限）/ Age maximum | Not applicable | |
| 性別 / Gender | 男女両方 | Male and Female |
| 選択基準 / Include criteria | 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 | |
| 除外基準 / Exclude criteria | 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. |
責任研究者
| 責任研究者 / Name of lead principal investigator | Akihiro Takeshita | |
|---|---|---|
| 組織名 / Organization | ||
| 部署名 / Division | Hamamatsu University School of Medicine Internal Medicine | |
| 住所 / Address | 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan | |
| 電話 / Telephone | (+81)-53-433-4993 | |
| 実施責任組織 / Affiliation | 日本成人白血病治療共同研究グループ(JALSG) | Hamamatsu University School of Medicine Internal Medicine |
| 研究費提供組織 / Funding Source | Ministry of Health, Labor and Welfare | |
| 共同実施組織 / Funding Source | ||
| 受付ID |
試験問い合わせ窓口
| 住所 / Address | 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan 431-3192 | |
|---|---|---|
| 電話 / Telephone | (+81)-53-433-4993 | |
| ホームページURL | ||
| akihirot@hama-med.ac.jp | ||
| 担当者 / Name of contact person | Akihiro Takeshita |