再発/難治性大粒状Tリンパ性白血病におけるリンペルリシブの有効性と安全性
再発/難治性大粒状Tリンパ球性白血病におけるPI3K阻害剤の有効性と安全性に関する第2相多施設共同単群非盲検試験
This is a prospective, multicenter, single-arm, phase 2 study. This study aims to evaluate the efficacy and safety of Linperlisib, the PI3K delta inhibitor for patients with relapsed/refractory large granular T lymphocytic leukemia.
調査の概要
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
-
-
Anhui
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Hefei、Anhui、中国
- Anhui Provincial Hospital
-
-
Henan
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Zhoukou、Henan、中国
- Zhoukou Central Hospital
-
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Tianjin Municipality
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Tianjin、Tianjin Municipality、中国
- Regenerative Medicine Center
-
-
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:
- Male or female age ≥ 18 years
- Diagnosis of T-cell large granular lymphocytic leukemia (T-LGLL)
- Meet any of the following indications for treatment： 1. Hemoglobin < 100g/L or RBC transfusion dependence 2. Neutrophil count <0.5×10^9/L or neutrophil count decreased with recurrent infection 3. Progressive splenomegaly and/or Massive Splenomegaly 4. Combined with autoimmune diseases requiring treatment, such as rheumatoid arthritis, autoimmune thyroiditis, etc. 5. Severe B symptoms
- Failure or intolerance to a first-line therapy
- ECOG performance status ≤2
- Expected survival ≥ 6 months
- Willing and able to comply with the requirements for this study and written informed consent
Exclusion Criteria:
- History of other lymphoproliferative neoplasms
- Had malignant tumor within 5 years before enrollment, exclusive of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial tumor, cervical carcinoma in situ or other indolent tumors
- Previously received organ or stem cell transplantation
- Patients with active infection within 2 weeks before giving the first dose of medication
- Patients with HBV, HCV, HIV or other infections that require treatment
- History of immunodeficiency, or congenital immunodeficiency disorders
- Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including clinically significant cardiac diseases, refractory hypertension, metabolic disorders and other diseases that seriously affect the function of the gastrointestinal tract.
- Abnormal liver function: two consecutive examinations with an interval of ≥1 week suggest that ALT and AST are 2.5 times higher than the upper limit of normal values
- Renal impairment: creatinine clearance <30ml/min
- History of mental illness
- History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc.
- Received attenuated vaccine 4 in weeks before enrollment
- Participation in another clinical trial within 4 weeks before the start of this trial
- Have an allergy to Linperlisib or any other part of this medicine.
- Pregnant or breast-feeding patients
- Patients considered to be ineligible for the study by the investigator for reasons other than the above
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：なし
- 介入モデル：単一グループの割り当て
- 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：Linperlisib
Linperlisib was administered at 80 mg every day, orally in a 28-day cycle until disease progression or intolerable toxicity occurred. |
Elevated PI3K activity in T-LGL likely plays an important role in the ability of the pathologic cells to avoid homeostatic apoptosis, since inhibition of this pathway leads to apoptosis in the population of cells harboring the pathologic clone. More importantly, the activity of this pathway may represent a kind of "Achilles heel" for T-LGL in that PI3K inhibitors alone are quite effective at inducing spontaneous apoptosis in the clonal CTLs after a short incubation.
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 |
|---|---|---|
|
Proportion of patients with hematologic remission
時間枠：8-12 weeks
|
Hematological response is evaluated by hemoglobin (Hb), absolute neutrophil count (ANC), platelet count (PLT), absolute lymphocyte count (ALC), absolute large granular lymphocyte count, and blood transfusion. |
8-12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of the adverse event
時間枠：8-12 weeks
|
Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess the adverse event Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess the adverse event Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess the adverse event |
8-12 weeks
|
協力者と研究者
協力者
捜査官
- 主任研究者：Jun Shi, PhD、Institute of Hematology & Blood Diseases Hospital, China
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
追加の関連 MeSH 用語
その他の研究ID番号
- IIT2023083
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?
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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