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治験 NCT06742463（対象：Acute T Lymphpblastic Leukemia/Lymphoma）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
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VHAG in Treating R/R T-ALL/LBL 第II相・フェーズ2 50 全生存期間
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治験番号 NCT06742463 は Acute T Lymphpblastic Leukemia/Lymphoma に関する 治療 の研究で、第II相・フェーズ2 介入研究 臨床試験 です。現在は 募集中 で、2024年12月1日 から開始しています。50 名の参加者 の募集が計画されています。この試験は First Affiliated Hospital of Zhejiang University によって主導され、2028年6月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2024年12月19日 です。
概要
Acute T cell lymphoblastic leukemia/lymphoma (T-ALL/LBL) is an aggressive type of leukemia that results from the malignant evolution of T-lineage progenitor cells at different differentiation stages. After induction chemotherapy and consolidation chemotherapy, there are still about 30% of patients who cannot achieve complete remission of clinical symptoms or negative MRD. This is also an important factor for the recu...もっと見る
詳細説明
This is a prospective, single-arm, phase II and open-label study. A total of 50 R/R T-ALL/LBL participants will be enrolled. The primary endpoint is complete remission with or without peripheral blood cell recovery. The induction therapy is a combination of Venetoclax(Ven), Homoharringtonine(HHT) , Cytarabine and G-CSF. The purpose of this study is to explore efficacy of the VHAG in the treatment of R/R T-ALL/LBL pat...もっと見る
公式タイトル
Venetoclax Combined With HAG Regimen in Treating Adult Relapse/Refractory Acute T Cell Lymphoblastic Leukemia/Lymphoma: A Phase II, Single Arm and Multicenter Study
疾患名
Acute T Lymphpblastic Leukemia/Lymphoma刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- IIT20240113C
NCT番号
開始日
2024-12
最終更新日
2024-12-19
終了予定日
2028-06-30
目標参加者数
50
試験の種類
介入研究
治験の相・段階
第II相・フェーズ2
状況
募集中
キーワード
acute lymphoblastic leukemia
chemotherapy
relapse
refractory
chemotherapy
relapse
refractory
主目的
治療
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Treatment arm Venetoclax for 4weeks(adjust according to BM on Day15), oral; Homoharringtonine for 1 week,iv; Cytarabine for 10-14 dsys, sc; G-CSF. | Venetoclax BCL-2 inhibitor homoharringtonine alkaloid Cytarabine (Ara-C) Metabolic antagonist. G-CSF Granulocyte colony-stimulating factor |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Complete remission with or without incomplete PB cell recovery(CR/CRi) rate | Blast rate lower than 5% with or without peripheral blood cell recovery | at the end of Cycle 1 and 2（each cycle is 28days） |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Overall survival (OS) | Defined for all patients in a trial; measured from day 1 of treatment to the date of death from any cause; | up to 5 years |
Event free survival(EFS) | Defined for all patients in a trial; measured from day 1 of treatment to the date of treatment failure, hematologic relapse from CR/CRi or death from any cause, whichever occurs first; | up to 2 years |
Minimal residual disease (MRD) | MRD level detected by flow cytometry which value \<0.1% is defined as negtive | At the end of Cycle 1 and 2（each cycle is 28 days） |
Adverse event | Safety of induction therapy | At the end of Cycle 1 and 2 |
参加アシスタント
適格基準
対象年齢
小児, 成人, 高齢者
試験の最低年齢
14 Years
対象性別
全て
- 1. Before enrollment, a diagnosis of newly diagnosed T-cell acute leukemia/lymphoma.The diagnostic criteria refer to the 2022 WHO classification; 2. Age ≥ 14 years,<75 years; 3. Clincally diagnosed as relapsed or refractory T-ALL/LBL; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 5. Expected survival time ≥ 2 months; 6. No organ dysfunction that would restrict the use of this protocol during the screening period; 7. Understand the study and sign the informed consent form.
- 1. Patients with known central nervous system (CNS) involvement of T-ALL/LBL; 2. Diseases with abnormal heart, lung, liver, kidney, or other organ functions that may limit the patient's participation in this trial (including but not limited to severe infections, uncontrolled diabetes, severe heart failure or angina, active pulmonary tuberculosis, asthma, COPD, bronchiectasis, etc.) 3. Cardiac ultrasound LVEF < 45%; 4. History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer; 5. Serum total bilirubin > 1.5 ULN (upper limit of normal); ALT or AST > 2.5 ULN; serum creatinine > 1.5 ULN; 6. Known HIV infection; 7. Conditions affecting the use of the study drug as assessed by the investigator; 8. Inability to understand or comply with the study protocol.
First Affiliated Hospital of Zhejiang University試験中央連絡先
連絡先: Jie Jin, M.D., +8657187236896, [email protected]
連絡先: Chenying Li, Ph.D., +8657187236896, [email protected]
1 1カ国の場所
Zhejiang
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310003, China
Jie Jin, M.D., 連絡先, +86571-87236896, [email protected]
Jie Jin, M.D., 主任研究者
募集中