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Clinical Trial NCT07105579 for Leukemia, Relapse is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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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 Phase 2 31

Recruiting
Clinical Trial NCT07105579 is designed to study Prevention for Leukemia, Relapse. It is a Phase 2 interventional study that is recruiting, having started on August 1, 2025, with plans to enroll 31 participants. Led by First Affiliated Hospital of Zhejiang University, it is expected to complete by December 31, 2027. The latest data from ClinicalTrials.gov was last updated on August 6, 2025.
Brief Summary
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
Detailed Description
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...Show More
Official Title

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

Conditions
LeukemiaRelapse
Other Study IDs
  • ZJU-HSCT-BITEDLI
NCT ID Number
NCT07105579
Start Date (Actual)
2025-08
Last Update Posted
2025-08-06
Completion Date (Estimated)
2027-12-31
Enrollment (Estimated)
31
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
hematopoietic stem cell transplantation
Blinatumomab
Donor Lymphocyte Infusion
Ph negative B cell Acute Lymphoblastic Leukemia
Primary Purpose
Prevention
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalBlinatumomab 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...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The 2-year leukemia-free survival (LFS) after allo-HSCT.
2 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Minimum Age
14 Years
Eligible Sexes
All
  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
Study Central Contact
Contact: Yi Luo, MD, 86-13666609126, [email protected]
Contact: Luxin Yang, MD, 86-13588756650, [email protected]
1 Study Locations in 1 Countries
First Affiliated Hospital of Zhejiang University, Hangzhou, China
Recruiting