Blinatumomab plus donor lymphocyte infusion to prevent relapse after transplant in high-risk Ph-negative B‑cell ALL

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

This trial tests whether giving blinatumomab together with donor lymphocyte infusions can help prevent relapse in people aged 14–65 with high‑risk Philadelphia chromosome–negative B‑cell acute lymphoblastic leukemia after an allogeneic stem cell transplant.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Ages: 14 Years to 65 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (other)
• Drugs / interventions: Blinatumomab, chemotherapy
• Locations: 1 site (Hangzhou)
• Trial ID: NCT07105579 on ClinicalTrials.gov

What this trial studies

This is a single‑arm Phase 2 maintenance trial that gives post‑transplant blinatumomab combined with planned donor lymphocyte infusion (DLI) to patients with high‑risk Ph‑negative B‑cell ALL. Eligible participants are at least two months post–allo‑HSCT, in marrow remission and MRD‑negative before starting treatment, with adequate organ function and no active severe graft‑versus‑host disease. The trial will monitor safety (including cytopenias and GVHD) and relapse rates to determine whether the regimen reduces post‑transplant recurrence. Treatment tolerability will also be tracked to characterize adverse events and feasibility of this combined maintenance approach.

Who should consider this trial

Good fit: Ideal candidates are patients aged 14–65 with Ph‑negative B‑cell ALL who have high‑risk features, are at least two months post–allo‑HSCT with marrow remission and MRD‑negative status, good performance status, adequate organ function, and no active grade III/IV GVHD.

Not a fit: Patients with active severe GVHD, significant organ dysfunction, Ph‑positive disease, MRD‑positive marrow before enrollment, or who cannot travel to the study center are unlikely to be eligible or benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could lower post‑transplant relapse rates and improve disease‑free survival for high‑risk Ph‑negative B‑ALL patients.

How similar studies have performed: Previous work shows blinatumomab can induce remissions in relapsed/refractory Ph‑negative B‑ALL and prophylactic DLI can reduce post‑transplant relapse, but combining blinatumomab with scheduled DLI as post‑transplant maintenance remains relatively novel and not widely proven.

Eligibility criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Where this trial is running

Hangzhou

• First Affiliated Hospital of Zhejiang University — Hangzhou, China (RECRUITING)

Study contacts

• Study coordinator: Yi Luo, MD

Conditions: Leukemia, Relapse, hematopoietic stem cell transplantation, Blinatumomab, Donor Lymphocyte Infusion, Ph negative B cell Acute Lymphoblastic Leukemia