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Recruiting Phase 1

Blinatumomab Combined With Low-dose DLI as Maintenance Therapy After Transplantation for B-ALL

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About this study

This prospective study will be conducted in high-risk B-ALL patients post-allo-HSCT. We propose to investigate the safety and therapeutic efficacy of blinatumomab plus low-dose DLI maintenance therapy, with the ultimate goal of enhancing long-term survival outcomes.

Condition
ALL (Acute B-Lymphoblastic Leukemia)
Tested
Blinatumomab Injection, Donor Lymphocyte Infusion (DLI)
Sponsor
Liping Dou

Who can join

Age
18 to 70 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 12

  • Minimum age: 18 years
  • Maximum age: 70 years
  • Study condition: ALL (Acute B-Lymphoblastic Leukemia)
  • 1\) Voluntary participation: The participant or legal guardian fully understands this clinical study, provides informed consent (ICF), and is willing/able to comply with all trial procedures.
  • \) Age: \<70 years old at screening, any gender. 3) Diagnosis: High-risk acute B-lymphoblastic leukemia (B-ALL) with MRD-negative status post-transplant. High-risk factors include:
  • \>CR1 status
  • Pre-transplant MRD+ status
  • Ph-like subtype
  • KMT2A rearrangement
  • Other high-risk cytogenetic/genetic factors per ELN 2023 criteria. 4) Allergy: No history of severe allergies. 5) Liver function: ALT and AST ≤ 2.5 × ULN; Total bilirubin ≤ 2 × ULN. 6) Renal function: Serum creatinine ≤ ULN. 7) Other conditions: Absence of uncontrolled infections or severe psychiatric disorders.
  • \) Performance status: ECOG score 0-3, with life expectancy ≥ 4 months. 9) MRD status: Bone marrow flow cytometry confirmed MRD-negative before enrollment.
  • \) Engraftment: Evidence of myeloid and platelet engraftment. 11) GVHD: No active graft-versus-host disease (GVHD).

Exclusion 8

  • 1\) Drug hypersensitivity/contraindications: Patients with known allergies or contraindications to the investigational drug(s).
  • \) Pregnancy/lactation: Pregnant or breastfeeding female patients. 3) Active infection/GVHD: Patients with active infection or active graft-versus-host disease (GVHD).
  • \) Substance abuse: Patients with chronic heavy smoking or alcohol use that may interfere with clinical evaluation.
  • \) Impaired consent/compliance: Patients unable to provide informed consent or comply with procedures due to psychiatric/neurological disorders.
  • \) Recent major surgery: Patients who underwent major organ surgery within the past 6 weeks.
  • \) Organ dysfunction:
  • Liver: ALT or AST \> 2.5 × ULN; Total bilirubin \> 2 × ULN
  • Kidney: Serum creatinine \> ULN 8) Investigator judgment: Patients deemed ineligible by investigators (e.g., poor compliance, substance abuse).

Where

1 site, 1 recruiting

Chinese PLA General Hospital

Beijing, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.