Trial Outcomes & Findings for Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL) (NCT NCT04506086)

Last Updated: 2025-05-18

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Cycle 1: Day 1 to Day 3; Cycle 2: Day 1 and Day 2

Results posted on

2025-05-18

Participant Flow

A total of 10 participants were enrolled in the United States from August 2021 to July 2024. This study was terminated by Amgen because of strategic reasons (slow enrollment) and not because of safety concerns.

Participants were administered blinatumomab as a continuous intravenous infusion (CiVI) in 2 mandatory cycles. Each cycle lasted 6 weeks (4 weeks of CiVI and 2-week treatment-free). Participants then had the option to continue for 2 additional cycles. Mandatory monitoring period (MDMP) was defined as the first 3 days of Cycle 1 and the first 2 days of Cycle 2. During MDMP, participants wore the current wearable health monitoring system to measure vital signs 24 hours a day.

Participant milestones

Participant milestones
Measure	Blinatumomab Participants received 28 ug/day blinatumomab as a CiVI in two 6-week cycles.
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Blinatumomab Participants received 28 ug/day blinatumomab as a CiVI in two 6-week cycles.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blinatumomab n=10 Participants Participants received 28 ug/day blinatumomab as a CiVI in two 6-week cycles.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	7 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: Cycle 1: Day 1 to Day 3; Cycle 2: Day 1 and Day 2

Population: Safety Analysis Set included all enrolled participants who received at least 1 dose of blinatumomab.

Outcome measures

Outcome measures
Measure	Blinatumomab n=10 Participants Participants received 28 ug/day blinatumomab as a CiVI in two 6-week cycles.
Number of Participants With Grade 3 and/or 4 Cytokine Release Syndrome (CRS), Neurotoxicity (NT) or Any Adverse Events Resulting in Hospitalization During MDMP	2 Participants

SECONDARY outcome

Timeframe: Cycle 1: Day 1 to Day 3; Cycle 2: Day 1 and Day 2

Population: Primary Analysis Set included all participants who received at least 1 dose of blinatumomab for whom the outpatient monitoring during blintumomab infusion was established.

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 \[ADL\]).

Outcome measures

Outcome measures
Measure	Blinatumomab n=10 Participants Participants received 28 ug/day blinatumomab as a CiVI in two 6-week cycles.
Time to Therapeutic Intervention (TTI) During MDMP	14.98 minutes Standard Deviation 26.76

SECONDARY outcome

Timeframe: Up to a maximum of 193 days

Population: Safety Analysis Set included all enrolled participants who received at least 1 dose of blinatumomab.

TEAEs were defined as adverse events starting on or after first dose of blinatumomab. EOIs referred in particular to CRS, infections and neurologic events.

Outcome measures

Outcome measures
Measure	Blinatumomab n=10 Participants Participants received 28 ug/day blinatumomab as a CiVI in two 6-week cycles.
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE) and Adverse Events of Interest (EOIs) TEAEs	10 Participants
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE) and Adverse Events of Interest (EOIs) EOIs	8 Participants

SECONDARY outcome

Timeframe: Baseline and Cycle 2 Day 1

Population: Patient-Reported Outcomes (PRO) Analysis Set included all participants in the safety analysis set with a non-missing baseline and at least 1 non-missing post-baseline result for EORTC QLQ-C30.

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 change for the global health status/QoL scale represents a lower QoL, a negative change for a functional scale represents a lower level of functioning, a positive change for a symptom scale/item represents a higher level of symptomatology/problems.

Outcome measures

Outcome measures
Measure	Blinatumomab n=4 Participants Participants received 28 ug/day blinatumomab as a CiVI in two 6-week cycles.
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 Score EORTC QLQ-C30 Global Health Status/QoL Score	-8.333 score on a scale Standard Deviation 11.785
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 Score EORTC QLQ-C30 Functional Scales Score	-12.778 score on a scale Standard Deviation 12.222
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 Score EORTC QLQ-C30 Symptoms Scales Score	4.487 score on a scale Standard Deviation 6.743

SECONDARY outcome

Timeframe: Up to a maximum of 193 days

Population: Safety Analysis Set included all enrolled participants who received at least 1 dose of blinatumomab.

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 the onset of a TEAE.

Outcome measures

Outcome measures
Measure	Blinatumomab n=10 Participants Participants received 28 ug/day blinatumomab as a CiVI in two 6-week cycles.
Number of Participants Who Experienced TEAEs That Resulted in Hospitalization, Surgeries, Use of Concomitant Medications or Use of Device/Procedure Intervention Hospitalizations	3 Participants
Number of Participants Who Experienced TEAEs That Resulted in Hospitalization, Surgeries, Use of Concomitant Medications or Use of Device/Procedure Intervention Surgeries	0 Participants
Number of Participants Who Experienced TEAEs That Resulted in Hospitalization, Surgeries, Use of Concomitant Medications or Use of Device/Procedure Intervention Use of concomitant medications	9 Participants
Number of Participants Who Experienced TEAEs That Resulted in Hospitalization, Surgeries, Use of Concomitant Medications or Use of Device/Procedure Intervention Use of device/procedure intervention	3 Participants

Adverse Events

Blinatumomab

Serious events: 4 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Blinatumomab n=10 participants at risk Blinatumomab 28 ug/24h CIV open label
General disorders Pyrexia	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Immune system disorders Cytokine release syndrome	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Sepsis	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Encephalopathy	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Blinatumomab n=10 participants at risk Blinatumomab 28 ug/24h CIV open label
Blood and lymphatic system disorders Neutropenia	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Palpitations	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Sinus tachycardia	20.0% 2/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Vision blurred	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	20.0% 2/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Chills	20.0% 2/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Fatigue	20.0% 2/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Malaise	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Non-cardiac chest pain	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Oedema peripheral	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Pyrexia	30.0% 3/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Immune system disorders Cytokine release syndrome	30.0% 3/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Immune system disorders Hypersensitivity	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Candida infection	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Enterocolitis infectious	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Subcutaneous abscess	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fall	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Vascular access complication	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood creatinine increased	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Human rhinovirus test positive	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Neutrophil count decreased	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations White blood cell count decreased	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Groin pain	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Joint effusion	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dizziness	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Headache	30.0% 3/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Tremor	30.0% 3/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Confusional state	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Ingrowing nail	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin ulcer	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Deep vein thrombosis	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypertension	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypotension	20.0% 2/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Superficial vein thrombosis	10.0% 1/10 • Up to a maximum of 193 days All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER