Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)
TerminatedPhase 4Results postedLast updated 18 May 2025
What this trial tests
Phase 4 trial testing Blinatumomab in B-precursor Acute Lymphoblastic Leukemia in 10 participants. Terminated before completion.
Adults 18 to 99, any sex, with B-precursor Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Grade 3 and/or 4 Cytokine Release Syndrome (CRS), Neurotoxicity (NT) or Any Adverse Events Resulting in Hospitalization During MDMPPrimary· Cycle 1: Day 1 to Day 3; Cycle 2: Day 1 and Day 2
Adverse event were graded using the Common Terminology Criteria for Adverse Events, (CTCAE) v5.0 grading Scale. Grade 3 events were defined as severe or medically significant but not immediately life-threatening; grade 4 events were defined as life-threatening consequences; urgent intervention indicated.
CSR is a heightened T-cell activation and release of pro inflammatory cytokines. NT signs include encephalopathy, delirium, aphasia, lethargy, difficulty concentrating, agitation, tremor, seizures, and, rarely, cerebral edema.
Group
Value
95% CI
Blinatumomab
2
Time to Therapeutic Intervention (TTI) During MDMPSecondary· Cycle 1: Day 1 to Day 3; Cycle 2: Day 1 and Day 2
TTI was calculated for all the valid alarm triggers which lead to an intervention as duration (in minutes) from time of the device alert (alarm triggered) to the time of initiation of the therapeutic intervention.
Therapeutic intervention was any measurable action taken by the participants or performed on the participants as a result of the onset of fever, hypotension, hypoxia, other grade 3 or 4 vital sign including seizure or neurological change (grade 3-limiting self-care activities of daily living \[ADL\]).
Group
Value
95% CI
Blinatumomab
14.98
± 26.76
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE) and Adverse Events of Interest (EOIs)Secondary· Up to a maximum of 193 days
TEAEs were defined as adverse events starting on or after first dose of blinatumomab. EOIs referred in particular to CRS, infections and neurologic events.
TEAEs
Group
Value
95% CI
Blinatumomab
10
EOIs
Group
Value
95% CI
Blinatumomab
8
Change From Baseline to Cycle 2 Day 1 in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients (QLQ-C30) Global Health Status/ Quality of Life ScoreSecondary· Baseline and Cycle 2 Day 1
The EORTC QLQ-C30 is a 30-item questionnaire that assesses the health related quality of life of cancer patients participating in clinical trials. The EORTC QLQ-C30 forms a global health status (GHS)/quality of life (QoL) scale, 5 functional domains (physical, role, emotional, cognitive and social), and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales/items measures get mapped to a common range from 0 to 100. A high scale score represents a higher response level. Thus, a negative chan
EORTC QLQ-C30 Global Health Status/QoL Score
Group
Value
95% CI
Blinatumomab
-8.333
± 11.785
EORTC QLQ-C30 Functional Scales Score
Group
Value
95% CI
Blinatumomab
-12.778
± 12.222
EORTC QLQ-C30 Symptoms Scales Score
Group
Value
95% CI
Blinatumomab
4.487
± 6.743
Number of Participants Who Experienced TEAEs That Resulted in Hospitalization, Surgeries, Use of Concomitant Medications or Use of Device/Procedure InterventionSecondary· Up to a maximum of 193 days
Concomitant therapies are any concomitant medications or treatments deemed necessary to provide adequate supportive care except for:
Any anti-tumor therapy other than the protocol-specified therapy (ie, radiation therapy, immunotherapy, cytotoxic and/or cytostatic drugs); Chronic systemic (\> 7 days) high-dose corticosteroid therapy (dexamethasone \> 24 mg/day or equivalent); any other immunosuppressive therapies (except for transient use of corticosteroids); Any other investigational agent. Intervention is any measurable action taken by the subject or performed on the subject as a result of
Hospitalizations
Group
Value
95% CI
Blinatumomab
3
Surgeries
Group
Value
95% CI
Blinatumomab
0
Use of concomitant medications
Group
Value
95% CI
Blinatumomab
9
Use of device/procedure intervention
Group
Value
95% CI
Blinatumomab
3
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to a maximum of 193 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study aims to determine the safety and feasibility of complete outpatient blinatumomab administration for subjects with minimal/measurable residual disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL).
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07192237 — Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Patients With Measurable Residual Diseas
· Phase 2
· not yet recruiting
NCT07178912 — Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromoso
· Phase 2
· not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+
· Phase 1, PHASE2
· not yet recruiting
NCT06991920 — Immune-targeted Combination With Chemotherapy for Acute Leukemia of Ambiguous Lineage
· NA
· not yet recruiting
NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly
· Phase 3
· not yet recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 18 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04506086.