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

  • STATUS
    Recruiting
  • End date
    Dec 28, 2025
  • participants needed
    45
  • sponsor
    Amgen
Updated on 5 January 2022

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.

Details
Condition B-precursor Acute Lymphoblastic Leukemia
Treatment Blinatumomab
Clinical Study IdentifierNCT04506086
SponsorAmgen
Last Modified on5 January 2022

Eligibility

Yes No Not Sure

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
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