search
Back to results

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

Primary Purpose

B-precursor Acute Lymphoblastic Leukemia

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Blinatumomab
Current Wearable Heatlth Monitoring System (CWHMS)
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-precursor Acute Lymphoblastic Leukemia focused on measuring Blinatumomab, Leukemia, Acute lymphoblastic leukemia, B-precursor Acute Lymphoblastic Leukemia, Minimal/Measurable Residual Disease, Bi-specific T-cell engager

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
    • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • City of Hope National Medical CenterRecruiting
  • University of California Los AngelesRecruiting
  • University of California IrvineRecruiting
  • Mayo Clinic Florida
  • Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando
  • Advocate Lutheran General Hospital
  • University of Nebraska Medical CenterRecruiting
  • Mount Sinai HospitalRecruiting
  • University of Rochester Cancer CenterRecruiting
  • Wake Forest Baptist Comprehensive Cancer Research CenterRecruiting
  • Saint Francis Hospital, IncRecruiting
  • University of Virginia Health SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blinatumomab

Arm Description

Outcomes

Primary Outcome Measures

Cycle 1: Incidence of grade 3 and/or 4 adverse events of special interest
Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).
Cycle 2: Incidence of grade 3 and/or 4 adverse events of special interest
Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).
Cycle 1: Incidence of any adverse events requiring hospitalization
Cycle 2: Incidence of any adverse events requiring hospitalization

Secondary Outcome Measures

Time (in minutes) from first 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 to therapeutic intervention
Incidence of treatment emergent Adverse events
Incidence of Adverse events of Special interest
Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).
Severity of treatment emergent adverse events
The investigator will make an assessment of severity for each adverse event reported during the study. The assessment of severity will be based on the Common Terminology Criteria for Adverse Events version 5.0.
Severity of adverse events of special interest
Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS). The investigator will make an assessment of severity for each adverse event reported during the study. The assessment of severity will be based on the Common Terminology Criteria for Adverse Events version 5.0.
Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
Incidence of treatment emergent adverse events that resulted in hospitalizations
Incidence of treatment emergent adverse events that resulted in surgeries
Incidence of treatment emergent adverse events that resulted in the use of concomitant medications
Incidence of treatment emergent adverse events that resulted in the use of device/procedure intervention.

Full Information

First Posted
July 27, 2020
Last Updated
October 16, 2023
Sponsor
Amgen
search

1. Study Identification

Unique Protocol Identification Number
NCT04506086
Brief Title
Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2021 (Actual)
Primary Completion Date
December 28, 2025 (Anticipated)
Study Completion Date
December 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blinatumomab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Blinatumomab
Other Intervention Name(s)
AMG 103, Blincyto
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Current Wearable Heatlth Monitoring System (CWHMS)
Intervention Description
The study will use the CWHMS device to monitor participants' vital signs while they are at home.
Primary Outcome Measure Information:
Title
Cycle 1: Incidence of grade 3 and/or 4 adverse events of special interest
Description
Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).
Time Frame
Day 1 to 3 of Cycle 1 (each cycle is 6 weeks)
Title
Cycle 2: Incidence of grade 3 and/or 4 adverse events of special interest
Description
Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).
Time Frame
Day 1 to 2 of Cycle 2 (each cycle is 6 weeks)
Title
Cycle 1: Incidence of any adverse events requiring hospitalization
Time Frame
Day 1 to 3 of Cycle 1 (each cycle is 6 weeks)
Title
Cycle 2: Incidence of any adverse events requiring hospitalization
Time Frame
Day 1 to 2 of Cycle 2 (each cycle is 6 weeks)
Secondary Outcome Measure Information:
Title
Time (in minutes) from first 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 to therapeutic intervention
Time Frame
Day 1 to 3 of Cycle 1, and Day 1 to 2 of Cycle 2 (each cycle is 6 weeks)
Title
Incidence of treatment emergent Adverse events
Time Frame
Up to 6 months
Title
Incidence of Adverse events of Special interest
Description
Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).
Time Frame
Up to 6 Months
Title
Severity of treatment emergent adverse events
Description
The investigator will make an assessment of severity for each adverse event reported during the study. The assessment of severity will be based on the Common Terminology Criteria for Adverse Events version 5.0.
Time Frame
Up to 6 months
Title
Severity of adverse events of special interest
Description
Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS). The investigator will make an assessment of severity for each adverse event reported during the study. The assessment of severity will be based on the Common Terminology Criteria for Adverse Events version 5.0.
Time Frame
Up to 6 months
Title
Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
Time Frame
Prior to treatment on Day 1 of Cycle 1 and 2 (each cycle is 6 weeks)
Title
Incidence of treatment emergent adverse events that resulted in hospitalizations
Time Frame
Up to 6 months
Title
Incidence of treatment emergent adverse events that resulted in surgeries
Time Frame
Up to 6 months
Title
Incidence of treatment emergent adverse events that resulted in the use of concomitant medications
Time Frame
Up to 6 months
Title
Incidence of treatment emergent adverse events that resulted in the use of device/procedure intervention.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868-3201
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Terminated
Facility Name
Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Completed
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Individual Site Status
Completed
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Rochester Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest Baptist Comprehensive Cancer Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Francis Hospital, Inc
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD Sharing URL
https://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

We'll reach out to this number within 24 hrs