Clinical trial · Interventional
Efficacy of Short-course Blinatumomab for MRD Erradication in B-ALL
Efficacy of Short-course Blinatumomab in Patients With Detectable Measurable Residual Disease With Philadelphia Chromosome-negative B-cell Acute Lymphoblastyc Leukemia
- 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)
Detectable measurable residual disease (MRD) is the most important prognostic factor for B-cell acute lymphoblastic leukemia (B-ALL) for overall survival (OS) and disease-free survival (DFS). Patients who are MRD positive and have no access to novel immunotherapies should receive an allogeneic hematopoietic stem cell transplantation (HSCT). Blinatumomab is considered a standard of care (SOC) for this group of patients, however, the ideal treatment dose for MRD is unknown as doses were adjusted from the relapsed/refractory setting. Preliminary data suggest short cycles of blinatumomab can also be effective in states of lower disease burden prior to transplant. Thus, the investigators are performing a phase 2 trial assessing 7 days of blinatumomab as a bridge to HSCT Primary endpoint is assessing the MRD response following a short-course blinatumomab infusion in patients with B-ALL with complete response (CR) and have detectable MRD disease who are candidates for HSCT. Secondary endpoints include incidence of adverse events, OS, DFS, percentage of patients who receive HSCT, incidence of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Measurable Residual Disease (MRD) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Short course of blinatumomab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Blinatumomab arm
- description
- Patients will receive 7 days of blinatumomab with a fixed dose of 175 mcg through out 7 days
- interventionNames
- Drug: Short course of blinatumomab
Primary outcomes (1)
- measure
- Efficacy to eradicate MRD in negative Philadelphia-chromosome B-cell acute lymphoblastic leukemia
- timeFrame
- 24 months
- description
- Primary outcome is to determinate the efficacy of blinatumomab to eradicate MRD in a blood sample extracted by bone marrow aspiration and evaluated by next generation flow cytometry on the third day after blinatumomab completion (day 10 after initiation). MRD eradication will be defined as: undetectable (below limit of detection) disease through next generation flow cytometry.
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia * MRD detectable in complete response (above the limit of quantification according to FCM) * Performance status 0-2 on the ECOG scale * No prior organ damage * Having a potential related or unrelated donor Exclusion Criteria: * Performance status on the ECOG scale \>2 * HCT-CI \>3 points * Patients who do not wish to participate in clinical study. * Active central nervous system infiltration (CNS3) * Active extramedullary disease * Having previously received blinatumomab * Absence of related or unrelated donors
References
Publications (1)
- RESULTYin J, Cai X, Qian B, Liu Y, Li D. Short-Course Blinatumomab Treatment as a Bridge to Further Salvage Therapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia: A Retrospective Single-Center Study. Cancer Med. 2024 Dec;13(24):e70515. doi: 10.1002/cam4.70515. PMID 39692275