Clinical trial · Interventional
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
NCT07677878CI-TRIAL-00116572recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALL (Acute B-Lymphoblastic Leukemia) | Acute Lymphoblastic Leukemia | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blinatumomab Injection | Drug | Blinatumomab | ALIAS |
| Donor Lymphocyte Infusion (DLI) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BLINA+DLI
- description
- blinatumomab 9ug d1-7, 28ug d8-14, DLI ( CD3+cell 1×10\^5/kg)
- interventionNames
- Drug: Blinatumomab Injection
- Other: Donor Lymphocyte Infusion (DLI)
Primary outcomes (1)
- measure
- 1 year progression-free-survival
- timeFrame
- 1 year
- description
- the percentage of patients who remain alive and whose disease has not gotten relapse one full year after they started treatment.
Secondary outcomes (4)
- measure
- 1 year aGVHD rate
- timeFrame
- 100 days after transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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: \<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).
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).References
Publications (0)
Data not yet available
No reference posted for this study.