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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLiping Dou

About this trial

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.

Eligibility criteria

Qualifiers

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.

>CR1 status

Pre-transplant MRD+ status

Ph-like subtype

Disqualifiers

1) Drug hypersensitivity/contraindications: Patients with known allergies or contraindications to the investigational drug(s).

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).

Trial design

Treatments tested in this trial

  • Blinatumomab Injection
  • Donor Lymphocyte Infusion (DLI)

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators

Liping Dou

Lead sponsor

Chinese PLA General Hospital

Sponsor institution