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

NCT04506086

Description:

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.

Related Conditions:
  • B-Cell Acute Lymphoblastic Leukemia
Recruiting Status:

Not yet recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: 20190014
  • NCT ID: NCT04506086

Conditions

  • B-precursor Acute Lymphoblastic Leukemia

Interventions

DrugSynonymsArms
BlinatumomabAMG 103, BlincytoBlinatumomab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
BlinatumomabExperimental
  • Blinatumomab

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-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
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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)
Safety Issue:
Description:Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).

Secondary Outcome Measures

Measure: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)
Safety Issue:
Description:
Measure:Incidence of treatment emergent Adverse events
Time Frame:Up to 6 months
Safety Issue:
Description:
Measure:Incidence of Adverse events of Special interest
Time Frame:Up to 6 Months
Safety Issue:
Description:Adverse events of Special Interest (AESI): neurotoxicity (NT) and cytokine release syndrome (CRS).
Measure:Severity of treatment emergent adverse events
Time Frame:Up to 6 months
Safety Issue:
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.
Measure:Severity of adverse events of special interest
Time Frame:Up to 6 months
Safety Issue:
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.
Measure: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)
Safety Issue:
Description:
Measure:Incidence of treatment emergent adverse events that resulted in hospitalizations
Time Frame:Up to 6 months
Safety Issue:
Description:
Measure:Incidence of treatment emergent adverse events that resulted in surgeries
Time Frame:Up to 6 months
Safety Issue:
Description:
Measure:Incidence of treatment emergent adverse events that resulted in the use of concomitant medications
Time Frame:Up to 6 months
Safety Issue:
Description:
Measure:Incidence of treatment emergent adverse events that resulted in the use of device/procedure intervention.
Time Frame:Up to 6 months
Safety Issue:
Description:

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Amgen

Trial Keywords

  • Blinatumomab
  • Leukemia
  • Acute lymphoblastic leukemia
  • B-precursor Acute Lymphoblastic Leukemia
  • Minimal Residual Disease
  • Bi-specific T-cell engager

Last Updated

November 27, 2020