If update date in update history is before 2018/12/15, the information was created in accordance with the old format.

更新履歴 / update history information

項目名 / Item 日本語 / Japanese 英語 / English
最新登録日last update registered date 2021/12/07
最新掲載日last update posted date 2021/12/07
初回登録日first registered date 2018/11/29
初回掲載日first posted date 2018/12/07
結果概要初回登録日first registered date for the result
結果概要初回掲載日first posted date for the result
更新履歴update history 更新日 / updated date 最新照合日 / last reviewed date
2021/12/07 改訂 / revised
2020/12/21 改訂 / revised
2020/06/12 改訂 / revised
2019/07/11 改訂 / revised 2020/06/11
2018/11/29 新規作成 概要(日本語) / initial created summary (JA)

基本情報 / basic information

項目名 / Item 日本語 / Japanese 英語 / English
JapicCTI-No. JapicCTI-184233
他の登録機関other registries 無 / absence
IPD共有に関する計画plan to share IPD 無 / no
IPD共有に関する計画の詳細plan description

試験名 / title for the study

項目名 / Item 日本語 / Japanese 英語 / English
試験の名称scientific title 成人T細胞白血病リンパ腫(ATL)患者に対するベキサロテンの有効性,安全性及び薬物動態を評価する,多施設共同,2用量並行群デザイン,無作為化,非盲検,第II相試験 Multi-center, randomized, open-label and phase II study of bexarotene in patients with adult T-cell leukemia/lymphoma (ATL)
簡易な試験の名称public title ATL患者を対象としたBSC-1第II相臨床試験 Phase II study of BSC-1 in patients with ATL

試験に用いる薬剤等 / investigational material

項目名 / Item 日本語 / Japanese 英語 / English
試験対象薬剤等investigational material 医薬品 / medicine
試験対象薬剤等 / investigational material(s)
一般的名称等generic name etc. BSC-1(ベキサロテン) BSC-1 (bexarotene)
薬剤:試験薬剤INNINN of investigational material bexarotene
試験対象品目:薬剤:薬効分類コードinvestigational material:medicine:therapeutic category code 429 /
用法・用量、使用方法dosage and administration for investigational material 1日1回経口投与 Oral administration once a day
対照薬剤等 / control material(s)
一般的名称等generic name of control material - -
薬剤:対照薬剤INNINN of control material -
試験対象品目の対照:薬剤:薬効分類コードcontrol material:medicine:therapeutic category code
用法・用量、使用方法dosage and administration for control material - -

試験の概要 / brief summary

項目名 / Item 日本語 / Japanese 英語 / English
試験の目的objective 治療 / treatment
試験のフェーズphase フェーズ2 / phase2
試験の種類study type 介入試験 / interventional study
第1被験者登録・組み入れ日date of first enrolment 2019/02/01
予定試験期間expected duration of study 2018/11/01 ~ 2022/05/31
目標症例数target sample size 38
試験の概要brief summary ATL患者に対するベキサロテンの有効性,安全性及び薬物動態を評価する多施設共同試験である A multicenter trial to evaluate the efficacy, safety and pharmacokinetics of bexarotene in patients with adult T-cell leukemia/lymphoma (ATL)
試験のデザインstudy design 多施設共同,オープンラベル Multi-center, open-label
試験実施国・地域countries / regions of recruitment 日本 / Japan
適格基準inclusion criteria (1)血清抗HTLV-1抗体が陽性であることが確認されATLと診断された患者で,リンパ腫研究グループ(LSG)分類により以下のいずれかに該当する患者
- 急性転化の既往のない,くすぶり型又は予後不良因子*を有さない慢性型(以下,インドレントATL)
- 急性型,リンパ腫型又は予後不良因子*を有する慢性型(以下,アグレッシブATL),若しくは急性転化の既往を有するインドレントATL.ただし,1レジメン以上の化学療法(分子標的薬等を含む)により寛解が得られた患者
(3)スクリーニング時の一般状態[Eastern Cooperative Oncology Group(ECOG)によるPerformance Status]が0~2の患者
- 十分な腎機能(eGFR:65歳未満は60 mL/min/1.73 m^2以上,65歳以上は45 mL/min/1.73 m^2以上)を保持している患者
- 十分な肝機能(AST,ALT及び総ビリルビンが基準値上限の2.5倍未満)を保持している患者
- 十分な骨髄機能(ヘモグロビン8 g/dL以上,好中球数1,000 /μL以上,血小板数50,000 /μL以上)を保持している患者
(5)空腹時血清トリグリセリドが150 mg/dL以下の患者,又は脂質異常症治療薬により150 mg/dL以下にコントロールされている患者.後者の場合は,脂質異常症治療薬による治療を治験薬投与開始前に2週間以上変更せずに継続し,安定していること


1. Patients who were confirmed as positive for serum anti-HTLV-1 antibody and diagnosed with ATL and who were classified according to the lymphoma research group (LSG) classification as one of the following.
a) Smoldering type and chronic type not accompanied with unfavorable factor (indolent ATL).
b) Acute type, lymphoma type, or chronic type accompanied with unfavorable factor (aggressive ATL), or indolent ATL who achieved a response by more than one regimen of chemotherapy (include molecular targeted drugs) with history of acute transformation.
2. Patients who are 20 years of age or older on the date of obtaining consent to participate in the trial.
3. Patients with general condition score [Eastern Cooperative Oncology Group (ECOG) Performance Status] 0 to 2 at screening.
4. Patients whose major organs function are adequate
a) Patients with adequate renal function (eGFR: 60 mL/min/1.73 m^2 or more if the patient under 65 years old, 45 mL/min/1.73 m^2 or more if the patient 65 years old and over).
b) Patients with adequate liver function (AST, ALT and total bilirubin are less than 2.5 times the upper limit of the reference value).
c) Patients with adequate bone marrow function (hemoglobin 8 g/dL or more, neutrophil count 1,000 /uL or more, platelet count 50,000 /uL or more).
5. Patients with fasting serum triglycerides below 150 mg/dL or patients controlled to 150 mg/dL or less with drugs.
In the latter case, treatment with a drug for the treatment of dyslipidemia is continued without changing for 2 weeks or more before starting administration of the investigational drug, and the condition is stable.
6. About fertile female subjects:
The serum pregnancy test (beta-hCG) performed within 7 days before the start of study drug administration is negative.
And patients who were contraceptive by the effective methods for the period from 4 weeks before the negative result was obtained until the start of the investigational drug administration.
7. Patients who can agree to use adequate contraception, hormonal or barrier methods.
Fertile female subject:
During the study drug administration and for 1 month after completion of study drug administration.
Male subjects who have fertile partners:
During the study drug administration and for 3 months after completion of study drug administration.
8. Patient who agreed in writing about participation in this trial.
適格基準:年齢(下限)minimum age 20 歳 / year
適格基準:年齢(上限)maximum age 制限なし / no limitation
適格基準:性別gender 両方 / both
除外基準exclusion criteria (1)中枢神経病変を伴うATLの患者
(4)skin-directed therapy†による治療が可能であると治験責任医師又は治験分担医師が判断した患者

†:本治験におけるskin-directed therapyとは,以下を指す.:
1. ATL patients with central nervous involvement.
2. Patients complicated with active cancer at screening.
3. Patients with HTLV-1 associated myelopathy (HAM) or HTLV-1 associated uveitis (HU).
4. Patient judged by investigator or clinical trial physician to be able to treat by skin-directed therapy.
5. Patients who are unlikely to survive for more than 24 weeks from the start of study drug administration.
6. Patients without lesions that can be evaluated by mSWAT at screening.
7. Patients who have been diagnosed with a skin disorder by a chemotherapy (including molecular targeted drugs) prior to the hospital visit for screening and who are judged by the investigator or the study doctor to have an impact on the evaluation of the drug.
8. Patients who were administered other investigational drugs within 12 weeks before starting study drug administration.
9. Pregnant patients, patients who may be pregnant, patients wishing for pregnancy, breastfeeding patients, or patients who can not accept appropriate contraceptive methods.
10. Patients with or having a history of hypersensitivity to the ingredients of the investigational drug or related preparations (retinoid).
11. Patients with history of pancreatitis or risk factors for pancreatitis.
12. Patients with severe complications or severe infections.
13. Patients with a history of serious allergies or severe drug hypersensitivity.
14. Patients who do not want to avoid or can not avoid long-time sunlight or UV light.
15. On other, patients judged not to be appropriate for participation in the trial by investigators.
疾患名health condition or problem studied 成人T細胞白血病リンパ腫 Adult T-cell leukemia/lymphoma
評価項目・方法:主要な評価項目 / primary outcome
評価項目・方法:主要な評価項目primary outcome 有効性 / efficacy
Response rate (best overall response)
評価項目・方法:副次的な評価項目 / secondary outcome
評価項目・方法:副次的な評価項目secondary outcome 安全性 / safety
有効性 / efficacy
薬物動態 / pharmacokinetics



Best overall response rate
Response duration
Time to response
Disease control rate
Time to progression
Incidence of acute transformation

Adverse event
Severity (grade)
Relevance with investigational drug

Evaluation of plasma pharmacokinetic profile
Pharmacokinetic parameters
試験実施施設examination facility
試験の現状study status 実施中 / progressing
被験者募集状況recruitment status 参加募集終了 / completed
試験終了日または中止日completion date or terminated date

IRB等に関する事項 / information about IRB(s)

項目名 / Item 日本語 / Japanese 英語 / English
名称name of IRB 今村総合病院治験審査委員会 Institutional Review Board of Imamura General Hospital
住所address of IRB 鹿児島県鹿児島市鴨池新町11-23 11-23, Kamoikeshinmachi, Kagoshima-shi, Kagoshima-ken, 890-0064, Japan
電話番号phone number of IRB
Eメールアドレスe-mail address of IRB
審査の状況status of IRB review 承認 / approved
承認日date of approval by IRB 2018/11/13

試験実施組織 / organizations

資金提供組織 / monetary sponsor

項目名 / Item 日本語 / Japanese 英語 / English
組織名称 / name of monetary sponsor
組織名称name of funding organization - -
研究費の名称name of research funding - -

問合せ先 / contact information

項目名 / Item 日本語 / Japanese 英語 / English
一般的な問合せ先 / public queries
会社名・機関名contact name for public queries 株式会社ミノファーゲン製薬 Minophagen Pharmaceutical Co., Ltd.
問合せ部署名department name for contact 研究開発本部 Research & Development Division
連絡先電話番号phone number
連絡先Eメールアドレスe-mail address rinshokaihatsubu1@minophagen.co.jp rinshokaihatsubu1@minophagen.co.jp
科学的な問合せ先 / scientific queries
会社名・機関名contact name for scientific queries 株式会社ミノファーゲン製薬 Minophagen Pharmaceutical Co., Ltd.
問合せ部署名department name for contact 研究開発本部 Research & Development Division
連絡先電話番号phone number
連絡先Eメールアドレスe-mail address rinshokaihatsubu1@minophagen.co.jp rinshokaihatsubu1@minophagen.co.jp

その他 / other

項目名 / Item 日本語 / Japanese 英語 / English
関連の試験番号とその名称related study ID number and its name
関連情報(既存薬の添付文書、審査報告書、新薬承認情報集等) / related information(e.c. package insert for existing medicine)
上記情報の簡易的な説明brief description

試験結果の概要 / result summary

項目名 / Item 日本語 / Japanese 英語 / English
出版物の掲載posting of journal publication
初回の出版物の掲載日date of the first journal publication of results
結果および出版物に関するURLURL hyperlink(s) related to results and publications
試験の対象者に関する背景情報baseline characteristics
実際の症例数actual enrolled number
試験の対象者のフローparticipant flow
有害事象に関するまとめadverse events
主要評価項目の解析結果primary outcome measures
副次的評価項目の解析結果secondary outcome measures
簡潔な要約brief summary
試験のプロトコールファイル:URLURL link to protocol file(s)
試験のプロトコールファイル:版、日付version and date of protocol file(s) 版: