Clinical trial · Interventional
Blinatumomab Maintenance After Allo-HSCT
Efficacy and Safety of Blinatumomab Maintenanceafter Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Acute B-lymphoblastic Leukemia: a Multicenter, Open-label, Randomized Controlled Study
NCT06438796CI-TRIAL-00077673not yet recruitingPhase 2ClinicalTrials.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)
To evaluate the safety and efficacy of Blinatumomab maintenance after allogeneic hematopoietic stem cell transplantation for high-risk acute B-lymphoblastic leukemia.
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 |
|---|---|---|---|
| High Risk Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blinatumomab | Drug | Blinatumomab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Blinatumomab group
- description
- Blinatumomab group (Blinatumomab): 9 μg/d intravenously over 24 hours until the end of d14 days of dosing. Repeat every 3 months for a total of 4 courses. (Basis for Dose Selection: The recommended dose of blinatumomab for MRD-negative patients is 9ug/d)
- interventionNames
- Drug: Blinatumomab
- type
- NO_INTERVENTION
- label
- Control group
- description
- Maintenance therapy in the control group was based on the routine maintenance therapy in each center (including but not limited to decitabine, sorafenib, prophylactic DLI, except for all types of CD19 mono- and dual-antibodies and CD22-ADC drugs).
Primary outcomes (1)
- measure
- 2-year Event-free survival
- timeFrame
- through study completion, an average of 2 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 16-65 years 2. Diagnosis with acute B-lymphoblastic leukemia (B-ALL) expressed CD19 3. High-risk group B-ALL 4. Have suitable hematopoietic stem cell donors 5. No dysfunction of vital organs Exclusion Criteria: 1. CR/MRD negative before blinatumomab maintenance 2. Active hepatitis B 3. HIV-infected 4. Active infections; acute and chronic GVHD requiring systemic immunosuppressive therapy; 5. severe impairment of vital organ function 6. Those judged by the investigator to be unsuitable for participation in this trial.
References
Publications (1)
- DERIVEDDavis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067. PMID 41671463