高悪性度B細胞リンパ腫の治療のための臭化セパントロニウム
再発/難治性c-Myc再構成高悪性度B細胞リンパ腫（HGBCL）患者における臭化セパントロニウムの第2相多施設非盲検用量設定試験
This is a multi-center Phase 2 study to determine the safety and efficacy of sepantronium bromide (SepB) in adult patients with relapsed or refractory high-grade B-cell lymphoma
調査の概要
状態
条件
介入・治療
詳細な説明
This is a multi-center, open label, dose-ranging Phase 2 study evaluating the safety and efficacy of SepB in patients with relapsed/refractory c-Myc rearranged HGBCL.
Cohorts of three patients will be enrolled at each dose level for SepB with expansion to six patients, if necessary, to assess toxicity.
Following the completion of 2 cycles of treatment of each cohort, an independent Data Monitoring Committee (DMC) will review the safety data to assess study drug related toxicities from the current cohort. Following this review, a decision will be made to continue dose escalation to the next dose level, to declare that a given dose level is the level of dose-limiting toxicity (DLT) or to further explore toxicity at the dose level in question by enrolling additional subjects to a maximum of six subjects at that level.
An additional 6 patients will be enrolled at the recommended Phase 2 dose (RP2D). The RP2D will be established on the basis of the maximally tolerated dose between the two specified dose levels as well as other relevant data, including clinical signals of activity, pharmacokinetic (PK) and pharmacodynamic (PD) data.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
-
Beijing、中国
- Beijing Cancer Hospital
-
Guangzhou、中国
- Sun Yat-sen University Cancer Center
-
Henan、中国
- Henan Cancer Hospital
-
Pudong、中国
- Shanghai East Hospital
-
Tianjin、中国
- Tianjin Cancer Hospital
-
Wuhan、中国
- Tongji Hospital
-
-
-
-
-
Busan、韓国
- Dong-A University Hospital
-
Busan、韓国
- Inje University Haeundae Paik hospital
-
Seoul、韓国
- Samsung Medical Center
-
Seoul、韓国
- Seoul National University Hospital
-
Seoul、韓国
- Seoul St.Mary's Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Confirmed histologic diagnosis of c-Myc rearranged high-grade B-cell lymphoma
- Relapse or refractory disease after at least one previous line of therapy
- Measurable disease as defined by 2014 Lugano classification
- ECOG performance status of 0-2
- Acceptable coagulation parameters
Exclusion Criteria:
- Allogeneic transplant within 3 months
- Autologous transplant without resolution of post-transplant cytopenias
- Known CNS involvement
- Average QT/QTc interval duration > 450 msec
- Inadequate marrow, hepatic or renal function
- Unresolved Grade 2 or greater toxicities from prior anticancer therapy
- Radiotherapy within prior 4 weeks
- Requires systemic immunosuppressive therapy
- Positive for Hepatis B or Hepatis C
- Seropositive for HIV
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Cohort 1
Cohort 1 will receive a dose of 3.6 mg/m2/day of sepantronium bromide |
continuous intravenous infusion
他の名前：
|
|
実験的：Cohort 2
Cohort 1 will receive a dose of 4.8 mg/m2/day of sepantronium bromide |
continuous intravenous infusion
他の名前：
|
|
実験的：Recommended Phase 2 Dose - Cohort 3
The recommended Phase 2 dose will be established based on the safety, pharmacokinetic and pharmacodynamic data from Cohort 1 and Cohort 2 |
continuous intravenous infusion
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety and tolerability and recommended Phase 2 dose of sepantronium bromide
時間枠：From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months
|
Frequency, severity and relatedness of adverse events and the frequency of adverse events requiring discontinuation of study drug or dose reductions |
From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall response rate
時間枠：From first dose through the last dose of study drug, an average of 6 months
|
The ORR is defined as the percentage of participants who achieve either a Partial Response or Complete Response at any time during the treatment phase |
From first dose through the last dose of study drug, an average of 6 months
|
|
Complete response rate
時間枠：From first dose of study drug through the last dose of study drug, an average of 6 months
|
Percentage of patients who experience a confirmed Complete Response at any time during the treatment phase |
From first dose of study drug through the last dose of study drug, an average of 6 months
|
|
Duration of response
時間枠：From first dose of study drug through to time of progression, an average of 6 months
|
Time from the first documentation of a Complete Response or a Partial Response until the time to objective tumor progression |
From first dose of study drug through to time of progression, an average of 6 months
|
|
Clinical benefit rate
時間枠：From first dose of study drug through the last dose of study drug, an average of 6 months
|
Proportion of patients who achieve a Complete Response, Partial Response or Stable Disease during the treatment phase |
From first dose of study drug through the last dose of study drug, an average of 6 months
|
|
Overall survival
時間枠：From first dose of study drug through date of death, irrespective of cause, an average of 6 months
|
The time from the first dose of study drug until death from any cause or date of last follow-up for living and lost to follow-up patients |
From first dose of study drug through date of death, irrespective of cause, an average of 6 months
|
|
Progression Free Survival
時間枠：From first dose of study drug through relapse, disease progression or death due to any cause, an average of 12 months
|
The time from first dose until relapse, disease progression or death due to any cause |
From first dose of study drug through relapse, disease progression or death due to any cause, an average of 12 months
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Vernon Jiang, PhD、Cothera Bioscience
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- PC002-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
IPD 共有時間枠
Beginning 9 months and ending 36 months following article publication.
IPD 共有アクセス基準
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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