B-precursor Acute Lymphoblastic LeukemiaPhase 4NCT04506086
Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)
A Phase 4 study testing Blinatumomab and Current Wearable Heatlth Monitoring System (CWHMS) in people with B-precursor Acute Lymphoblastic Leukemia, run by Amgen at 12 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- B-precursor Acute Lymphoblastic Leukemia
- What is being tested?
- Blinatumomab and Current Wearable Heatlth Monitoring System (CWHMS)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 12 sitesUnited States
- Study dates
- 26 Aug 2021to 16 Sep 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures OR subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent
- Age greater than or equal to 18 years
- B-cell precursor (BCP) acute lymphoblastic leukemia (ALL) with minimal/measurable residual disease defined as hematologic complete remission (CR) with less than 5% bone marrow blasts and meets clinical eligibility criteria to receive blinatumomab as outlined below.
- Hematologic criteria for remission as defined below:
- Less than 5% bone marrow blasts
- Absolute neutrophil count greater than or equal to 1.0 x10^9 L
Show all 18Show fewer
- Platelets greater than or equal to 50 x10^9/L (transfusion permitted)
- Hemoglobin level greater than or equal to 90 g/L (transfusion permitted)
- Renal and hepatic function as defined below:
- Total bilirubin <3 x upper limit of normal (ULN) unless related to Gilbert's or Meulengracht disease
- Serum creatinine <1.5 x ULN. If serum creatinine ≥1.5 x ULN, then measure Glomerular Filtration Rate (GFR); subject will be eligible only if measured GFR is within normal limits.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Negative pregnancy test in women of childbearing potential
- Ability and willingness to wear and comply with the instructions for the use of and monitoring of the digital monitoring devices as outlined in informed consent
- Subject resides within 1 hour of ground transportation to an advanced medical care facility for the duration of the mandatory device monitoring period (MDMP)
- Adequate cellular service available during MDMP.
- Presence of an adult (greater than or equal to 18 years) caregiver(s) in the same dwelling, for 24 hours/day for the entire MDMP. Caregiver will be expected to have access to transportation
- Ability and willingness to participate in the health management of the subject and to assist with the requirements of remote digital monitoring devices during the blinatumomab infusion within the MDMP
Who cannot join
- Presence of circulating blasts
- Presence of extramedullary disease
- History of relevant central nervous system (CNS) pathology or current relevant CNS pathology (seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, or coordination or movement disorders
- Current infiltration of cerebrospinal fluid (CSF) by ALL. If screening cerebrospinal fluid (CSF) demonstrates leukemic blasts, subjects must receive intrathecal treatment and demonstrate negative CSF before enrollment and starting blinatumomab infusion
- Current autoimmune disease or history of autoimmune disease with potential CNS involvement
- Allogeneic hematopoietic stem cell transplantation (HSCT) within 12 weeks before blinatumomab treatment
Show all 37Show fewer
- Active acute or chronic graft versus host disease (GvHD) requiring systemic treatment with immunosuppressive medication
- Systemic chemotherapy within 2 weeks prior to study treatment (except for intrathecal prophylaxis)
- Radiotherapy within 4 weeks prior to study treatment
- Known hypersensitivity to blinatumomab or to any component of the product formulation
- Active malignancy other than ALL with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
- History of other malignancy within the past 2 years, with the following exception[s]:
- Malignancy treated with curative intent and with no known active disease present for greater than or equal to 2 years before enrollment and felt to be at low risk for recurrence by the treating physician
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated cervical carcinoma in situ without evidence of disease
- Adequately treated breast ductal carcinoma in situ without evidence of disease
- Prostatic intraepithelial neoplasia without evidence of prostate cancer
- Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ
- Currently receiving treatment with an investigational device or drug study or less than 30 days since ending treatment on an investigational device or drug study(ies)
- Active uncontrolled infection requiring therapy
- Known infection or chronic infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive) or hepatitis C virus (HCV) (anti-HCV positive)
- Known positive test for human immunodeficiency virus (HIV)
- Any concurrent disease or medical condition deemed to interfere with the conduct of the study and remote digital monitoring as judged by the investigator
- Any acutely ill cardiac patients with the potential to develop life threatening arrhythmias eg, very fast atrial fibrillation
- Subjects with no cellular signal in their home
- Subjects with bi-lateral upper arm tattoos directly under the area of Current Wearable Health Monitoring System (CWHMS) application (Current Health wearable device)
- Subjects with a known allergy to any of the device component materials
- Subjects with open wounds on both arms directly under the area of CWHMS application (Current Health wearable device) or with injuries to both arms
- Subjects with an upper arm circumference of less than 20 cm or greater than 50 cm
- Subjects with an implantable defibrillator
- Subjects unwilling to wear the CWHMS (Current Health wearable device, axillary temperature patch) during the mandatory monitoring period (MDMP) in cycles 1 and 2
- Subjects with excessive scarring directly under the area of CWHMS (Current Health wearable device) application
- Subjects who cannot have their blood pressure (BP) measured in both arms (or wrists) eg due to atrio-venous shunt, risk of lymphedema or peripherally inserted central catheter line
- Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 48 hours after the last dose of protocol-specified therapy
- Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 48 hours after the last dose of protocol-specified therapy Refer to Section 11.5 for additional contraceptive information
- Female subjects of childbearing potential with a positive pregnancy test assessed at Screening by a serum pregnancy test and/or urine pregnancy test
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, patient reported outcomes [PROs]) to the best of the subject and investigator's knowledge
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Virginia Health System
Charlottesville, Virginia, 22908
City of Hope National Medical Center
Duarte, California, 91010
Saint Francis Hospital, Inc
Greenville, South Carolina, 29607
Mayo Clinic
Jacksonville, Florida, 32224
University of California Los Angeles
Los Angeles, California, 90095
Mount Sinai Hospital
New York, New York, 10029
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of California Irvine
Orange, California, 92868-3201
Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando
Orlando, Florida, 32804
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
University of Rochester Cancer Center
Rochester, New York, 14642
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase 4, Multi-center Open-label Feasibility Study to Evaluate Outpatient Blinatumomab Administration in Adult Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL) in Complete Hematologic Remission
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).
- Conditions
- B-precursor Acute Lymphoblastic Leukemia
- Being tested
- Blinatumomab, Current Wearable Heatlth Monitoring System (CWHMS)
- Keywords
- Blinatumomab, Leukemia, Acute lymphoblastic leukemia, B-precursor Acute Lymphoblastic Leukemia, Minimal/Measurable Residual Disease, Bi-specific T-cell engager
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
Also called AMG 103, Blincyto
Participants will receive blinatumomab continuous IV infusion for a maximum of 4 cycles. Each cycle is 6 weeks in duration consisting of 4 weeks of treatment and 2 weeks of rest.
Current Wearable Heatlth Monitoring System (CWHMS)Device
The study will use the CWHMS device to monitor participants' vital signs while they are at home.
| Study group | Role | What they receive |
|---|---|---|
| Blinatumomab | Experimental | Not described Receives: Drug: Blinatumomab; Device: Current Wearable Heatlth Monitoring System (CWHMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Grade 3 and/or 4 Cytokine Release Syndrome (CRS), Neurotoxicity (NT) or Any Adverse Events Resulting in Hospitalization During MDMP
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.
Measured: Cycle 1: Day 1 to Day 3; Cycle 2: Day 1 and Day 2
Secondary outcomes (4)
Time to Therapeutic Intervention (TTI) During MDMP
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]).
Measured: Cycle 1: Day 1 to Day 3; Cycle 2: Day 1 and Day 2
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE) and Adverse Events of Interest (EOIs)
TEAEs were defined as adverse events starting on or after first dose of blinatumomab. EOIs referred in particular to CRS, infections and neurologic events.
Measured: Up to a maximum of 193 days
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
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.
Measured: Baseline and Cycle 2 Day 1
Number of Participants Who Experienced TEAEs That Resulted in Hospitalization, Surgeries, Use of Concomitant Medications or Use of Device/Procedure Intervention
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.
Measured: Up to a maximum of 193 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start26 Aug 2021
- Primary completion4 Jul 2024
- Study completion16 Sep 2024
Why it stopped: The decision to terminate is not based on safety or efficacy but due to slow enrollment impacting the ability to complete the study as planned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for B-precursor Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506086
- Sponsor's protocol ID
- 20190014
- Status last verified
- Apr 2025
- First submitted
- 27 Jul 2020
- Last updated
- 18 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Multi-center Open-label Feasibility Study to Evaluate Outpatient Blinatumomab Administration in Adult Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL) in Complete Hematologic Remission
- ClinicalTrials.gov ID
- NCT04506086
- Acronym / sponsor ID
- 20190014
- Conditions
- B-precursor Acute Lymphoblastic Leukemia
- Keywords
- Blinatumomab, Leukemia, Acute lymphoblastic leukemia, B-precursor Acute Lymphoblastic Leukemia, Minimal/Measurable Residual Disease, Bi-specific T-cell engager
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision to terminate is not based on safety or efficacy but due to slow enrollment impacting the ability to complete the study as planned.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Posted 18 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blinatumomab | Experimental | Drug: Blinatumomab, Device: Current Wearable Heatlth Monitoring System (CWHMS) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures OR subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent
- Age greater than or equal to 18 years
- B-cell precursor (BCP) acute lymphoblastic leukemia (ALL) with minimal/measurable residual disease defined as hematologic complete remission (CR) with less than 5% bone marrow blasts and meets clinical eligibility criteria to receive blinatumomab as outlined below.
- Hematologic criteria for remission as defined below:
- Renal and hepatic function as defined below:
Key exclusion criteria (37 listed)
- Presence of circulating blasts
- Presence of extramedullary disease
- History of relevant central nervous system (CNS) pathology or current relevant CNS pathology (seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, or coordination or movement disorders
- Current infiltration of cerebrospinal fluid (CSF) by ALL. If screening cerebrospinal fluid (CSF) demonstrates leukemic blasts, subjects must receive intrathecal treatment and demonstrate negative CSF before enrollment and starting blinatumomab infusion
- Current autoimmune disease or history of autoimmune disease with potential CNS involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlinatumomabAlso: AMG 103, BlincytoParticipants will receive blinatumomab continuous IV infusion for a maximum of 4 cycles. Each cycle is 6 weeks in duration consisting of 4 weeks of treatment and 2 weeks of rest. | Drug | Blinatumomab |
| Current Wearable Heatlth Monitoring System (CWHMS)The study will use the CWHMS device to monitor participants' vital signs while they are at home. | Device | Blinatumomab |
Primary outcome
Number of Participants With Grade 3 and/or 4 Cytokine Release Syndrome (CRS), Neurotoxicity (NT) or Any Adverse Events Resulting in Hospitalization During MDMP
Time frame: 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.
4 secondary outcomes
Time to Therapeutic Intervention (TTI) During MDMP
Time frame: Cycle 1: Day 1 to Day 3; Cycle 2: Day 1 and Day 2
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE) and Adverse Events of Interest (EOIs)
Time frame: Up to a maximum of 193 days
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
Time frame: Baseline and Cycle 2 Day 1
Number of Participants Who Experienced TEAEs That Resulted in Hospitalization, Surgeries, Use of Concomitant Medications or Use of Device/Procedure Intervention
Time frame: Up to a maximum of 193 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blinatumomab and Current Wearable Heatlth Monitoring System (CWHMS) in people with B-precursor Acute Lymphoblastic Leukemia, run by Amgen at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Grade 3 and/or 4 Cytokine Release Syndrome (CRS), Neurotoxicity (NT) or Any Adverse Events Resulting in Hospitalization During MDMP (time frame: Cycle 1: Day 1 to Day 3; Cycle 2: Day 1 and Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.