NCT07677878RecruitingPhase 1
Blinatumomab Combined With Low-dose DLI as Maintenance Therapy After Transplantation for B-ALL
A Single-arm, Open-label, Phase I Clinical Study of Blinatumomab Combined With Low-dose DLI as Maintenance Therapy After Transplantation for B-ALL
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 16 Jun 2026
- Start date
- 1 Dec 2024
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Liping Dou
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT07677878
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From 1 Dec 2024 to the primary completion date, 30 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
Lab values
- 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).
Who the study is looking for
- 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: \<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.
- 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).
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.