Blinatumomab plus donor white blood cells after transplant for B-cell acute lymphoblastic leukemia
Tests blinatumomab with low-dose donor cell infusions after transplant in adults with B-ALL.
Plain-language title generated from the registry record
Registry title: Blinatumomab Combined With Low-dose DLI as Maintenance Therapy After Transplantation for B-ALL
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07677878, who can take part
Where in China
- Chinese PLA General HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Liping Dou
- Trial code
- NCT07677878
- Record updated
- 1 July 2026
- Original description
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.Read full original descriptionShow less
A Single-arm, Open-label, Phase I Clinical Study of Blinatumomab Combined With Low-dose DLI as Maintenance Therapy After Transplantation for B-ALL
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.
Inclusion: 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: 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).