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治験 NCT07105579（対象：白血病、再発）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。
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Effectiveness and Safety of Blinatumomab and Donor Lymphocyte Infusion in Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Ph Negative B Cell Acute Lymphoblastic Leukemia 第II相・フェーズ2 31

募集中
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治験番号 NCT07105579 は 白血病、再発 に関する 予防 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、2025年8月1日 から開始しています。31 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、2027年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年8月6日 です。
概要
A single-arm trial to evaluate the effectiveness and safety of Blinatumomab and Donor Lymphocyte Infusion in maintenance therapy after allogeneic hematopoietic stem cell transplantation for high-risk Ph negative B cell acute lymphoblastic leukemia
詳細説明
Currently, the treatment for Philadelphia chromosome (Ph)-negative adult B-cell acute lymphoblastic leukemia (B-ALL) primarily relies on traditional multi-agent combination chemotherapy. Clinical efficacy is closely associated with patient age, genetic characteristics, chemotherapy sensitivity, and minimal residual disease (MRD) status post-remission. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) rem...もっと見る
公式タイトル

Effectiveness and Safety of Blinatumomab and Donor Lymphocyte Infusion in Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Ph Negative B Cell Acute Lymphoblastic Leukemia：Phrase II, Exploratory Study

疾患名
白血病再発
その他の研究識別子
  • ZJU-HSCT-BITEDLI
NCT番号
NCT07105579
開始日
2025-08
最終更新日
2025-08-06
終了予定日
2027-12-31
目標参加者数
31
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
hematopoietic stem cell transplantation
Blinatumomab
Donor Lymphocyte Infusion
Ph negative B cell Acute Lymphoblastic Leukemia
主目的
予防
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Blinatumomab and Donor Lymphocyte Infusion
BITE and DLI
Blinatumomab dosage: Cycle 1 (starting at day 60 post-transplant):Days 1-3: 9 μg/day，Days 4-14: 28 μg/day Cycles 2-4:Days 1-14: 28 μg/day Administration method: Continuous 24-hour intravenous infusion, one cycle every 3 months. DLI eligibility criteria:No history of grade III-IV acute GVHD (aGVHD).No active aGVHD or chronic GVHD (cGVHD) at the time of infusion DLI dosage:Administered at day 120 post-HSCT, CD3+ cel...もっと見る
主要評価項目
評価指標指標の説明時間枠
The 2-year leukemia-free survival (LFS) after allo-HSCT.
2 years
副次評価項目
評価指標指標の説明時間枠
The 2-year overall survival（OS）
2-year overall survival from transplant
2 years
The 2-year cumulative incidence of relapse
2-years
The 2-year cumulative incidence of non-relapse mortality(NRM)
2-years
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. Age 14-65 years (inclusive), regardless of gender.
  2. Newly diagnosed B-ALL with CD19 expression on leukemic cells (regardless of CD19 positivity rate).
  3. Ph-negative B-ALL with high-risk features post-allo-HSCT .
  4. ≥2 months post-transplant with hematopoietic reconstitution.
  5. Bone marrow morphology in remission and MRD-negative before enrollment.
  6. ECOG performance status <3 and Karnofsky score ≥70.
  7. No history of grade III/IV graft-versus-host disease (GVHD) and no active GVHD at enrollment.
  8. Adequate organ function:AST and ALT ≤3× upper limit of normal (ULN), total bilirubin ≤2×ULN.Serum creatinine ≤2×ULN or creatinine clearance ≥50 mL/min (calculated by Cockcroft-Gault formula).Left ventricular ejection fraction (LVEF) ≥50% by echocardiography (ECHO).
  9. Expected survival >3 months.
  10. Voluntary provision of written informed consent, with ability to understand and comply with study requirements.

  1. History of hypersensitivity or severe adverse reactions to the study drug or structurally similar compounds, as assessed by the investigator to preclude participation.
  2. Pregnant or lactating women, or women of childbearing potential unwilling to use effective contraception.
  3. Severe cardiac dysfunction, including:Left ventricular ejection fraction (EF) <60%.Clinically significant arrhythmias (e.g., ventricular tachycardia, atrial fibrillation, second-degree heart block).Prolonged QTc interval (men >450 ms; women >470 ms).Myocardial infarction within the past year.Symptomatic coronary artery disease requiring medication.
  4. Severe pulmonary dysfunction (obstructive and/or restrictive ventilatory impairment).
  5. Severe hepatic impairment:ALT or total bilirubin (TBIL) >3× upper limit of normal (ULN).
  6. Severe renal impairment:Serum creatinine (Cr) >2× ULN.24-hour creatinine clearance (Ccr) <50 mL/min.
  7. Active infection or uncontrolled bleeding, as assessed by the investigator to preclude safe administration of the study drug.
  8. History of thrombosis, embolism, cerebral hemorrhage, or other significant vascular events within the past year.
  9. Psychiatric disorders or other conditions that impair the ability to provide informed consent or comply with study procedures.
  10. Major organ surgery within the past six weeks.
  11. Drug abuse or chronic alcoholism that may interfere with study assessments.
  12. Prior organ transplantation (excluding hematopoietic stem cell transplantation).
  13. Other conditions deemed by the investigator to make the patient unsuitable for participation.
First Affiliated Hospital of Zhejiang University logoFirst Affiliated Hospital of Zhejiang University
試験中央連絡先
連絡先: Yi Luo, MD, 86-13666609126, [email protected]
連絡先: Luxin Yang, MD, 86-13588756650, [email protected]
1 1カ国の場所
First Affiliated Hospital of Zhejiang University, Hangzhou, China
募集中