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NCT07677878
Blinatumomab Combined With Low-dose DLI as Maintenance Therapy After Transplantation for B-ALL
Conditions: ALL (Acute B-Lymphoblastic Leukemia)
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 60
Sponsor: Liping Dou
Location: Chinese PLA General Hospital Beijing
Summary
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
Inclusion Criteria:
* 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.
2\) Age: \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.
8\) Performance status: ECOG score 0-3, with life expectancy ≥ 4 months. 9) MRD status: Bone marrow flow cytometry confirmed MRD-negative before enrollment.
10\) Engraftment: Evidence of myeloid and platelet engraftment. 11) GVHD: No active graft-versus-host disease (GVHD).
Exclusion Criteria:
* 1\) Drug hypersensitivity/contraindications: Patients with known allergies or contraindications to the investigational drug(s).
2\) Pregnancy/lactation: Pregnant or breastfeeding female patients. 3) Active infection/GVHD: Patients with active infection or active graft-versus-host disease (GVHD).
4\) Substance abuse: Patients with chronic heavy smoking or alcohol use that may interfere with clinical evaluation.
5\) Impaired consent/compliance: Patients unable to provide informed consent or comply with procedures due to psychiatric/neurological disorders.
6\) Recent major surgery: Patients who underwent major organ surgery within the past 6 weeks.
7\) 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).
Source: ClinicalTrials.gov (NCT07677878). StuddyBuddy aggregates publicly available trial information.