Blinatumomab Combined With Low-dose DLI as Maintenance Therapy After Transplantation for B-ALL
Recruiting now · Phase 1
Conditions studied: ALL (Acute B-Lymphoblastic Leukemia)
In brief
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.
Key facts
- Study ID
- NCT07677878
- Run by
- Liping Dou
- People needed
- 60
- Starts
- 2024-12-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-07-01
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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 it is running
- Chinese PLA General Hospital — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.