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임상시험 NCT07105579은(는) 백혈병, 재발에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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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 2상 31

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임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07105579은(는) 예방을(를) 알아보기 위한 연구입니다. 이 연구는 백혈병, 재발에 대해 진행되며, 2상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 8월 1일에 시작되어 31명의 참여자를 모집하고 있습니다. First Affiliated Hospital of Zhejiang University이(가) 진행하며, 2027년 12월 31일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 8월 6일에 갱신되었습니다.
간단한 개요
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
상세한 설명
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...더 보기
공식 제목

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

질환명
백혈병재발
기타 연구 식별자
  • ZJU-HSCT-BITEDLI
NCT 번호
NCT07105579
실제 연구 시작일
2025-08
최신 업데이트 게시
2025-08-06
예상 연구 완료일
2027-12-31
계획된 등록 인원
31
연구종류
중재연구
단계/상
2상
상태
모집중
키워드
hematopoietic stem cell transplantation
Blinatumomab
Donor Lymphocyte Infusion
Ph negative B cell Acute Lymphoblastic Leukemia
주요 목적
예방
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적Blinatumomab 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...더 보기
주요결과변수
결과변수측정값 설명시간 범위
The 2-year leukemia-free survival (LFS) after allo-HSCT.
2 years
이차결과변수
결과변수측정값 설명시간 범위
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
참여 도우미
적격성 기준

연령대
어린이, 성인, 노인
최소 연령
14 Years
참여 가능한 성별
전체
  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
연구 대표 연락처
연락처: Yi Luo, MD, 86-13666609126, [email protected]
연락처: Luxin Yang, MD, 86-13588756650, [email protected]
1 1개국에 임상시험 장소
First Affiliated Hospital of Zhejiang University, Hangzhou, China
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