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

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ClinicalTrials.gov Identifier: NCT04506086
Recruitment Status : Not yet recruiting
First Posted : August 10, 2020
Last Update Posted : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The purpose of this study is to determine the safety and feasibility of outpatient blinatumomab administration for subjects with Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia.

Condition or disease Intervention/treatment Phase
B-precursor Acute Lymphoblastic Leukemia Drug: Blinatumomab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 19, 2021
Estimated Primary Completion Date : December 28, 2025
Estimated Study Completion Date : December 28, 2025


Arm Intervention/treatment
Experimental: Blinatumomab Drug: Blinatumomab
Subjects 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.
Other Names:
  • AMG 103
  • Blincyto




Primary Outcome Measures :
  1. Cycle 1: Incidence of grade 3 and/or 4 adverse events of special interest [ Time Frame: Day 1 to 3 of Cycle 1 (each cycle is 6 weeks) ]
    Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).

  2. Cycle 2: Incidence of grade 3 and/or 4 adverse events of special interest [ Time Frame: Day 1 to 2 of Cycle 2 (each cycle is 6 weeks) ]
    Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).

  3. Cycle 1: Incidence of any adverse events requiring hospitalization [ Time Frame: Day 1 to 3 of Cycle 1 (each cycle is 6 weeks) ]
  4. 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 Measures :
  1. 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) ]
  2. Incidence of treatment emergent Adverse events [ Time Frame: Up to 6 months ]
  3. Incidence of Adverse events of Special interest [ Time Frame: Up to 6 Months ]
    Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).

  4. Severity of treatment emergent adverse events [ Time Frame: Up to 6 months ]
    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.

  5. Severity of adverse events of special interest [ Time Frame: Up to 6 months ]

    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.


  6. 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) ]
  7. Incidence of treatment emergent adverse events that resulted in hospitalizations [ Time Frame: Up to 6 months ]
  8. Incidence of treatment emergent adverse events that resulted in surgeries [ Time Frame: Up to 6 months ]
  9. Incidence of treatment emergent adverse events that resulted in the use of concomitant medications [ Time Frame: Up to 6 months ]
  10. Incidence of treatment emergent adverse events that resulted in the use of device/procedure intervention. [ Time Frame: Up to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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-precursor ALL in hematologic CR defined as less than 5% bone marrow blasts with MRD positive disease and meet clinical eligibility criteria to receive blinatumomab as outlined below
  • Presence of MRD greater than or equal to 0,1%. Documented after an interval of at least 1 week from last systemic chemotherapy
  • 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:

    • Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase less than 3x upper limit of normal (ULN)
    • Total bilirubin less than 1.5x ULN unless related to Gilbert's or Meulengracht disease
    • Serum creatinine less than 1.5x ULN. If serum creatinine is greater than or equal to 1.5x ULN, then measure Glomerular Filtration Rate (GFR) in mL/min/1.73m^2 or mL/s/m^2; 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 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 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 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 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 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, PROs) to the best of the subject and investigator's knowledge

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04506086


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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United States, California
University of California at Irvine Medical Center
Orange, California, United States, 92868
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando
Orlando, Florida, United States, 32804
United States, Illinois
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
United States, North Carolina
Wake Forest Baptist Comprehensive Cancer Research Center
Winston-Salem, North Carolina, United States, 27157
United States, South Carolina
Saint Francis Hospital, Inc
Greenville, South Carolina, United States, 29607
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04506086    
Other Study ID Numbers: 20190014
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
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.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Blinatumomab
Leukemia
Acute lymphoblastic leukemia
B-precursor Acute Lymphoblastic Leukemia
Minimal Residual Disease
Bi-specific T-cell engager
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Blinatumomab
Antineoplastic Agents