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

NCT04506086 | Terminated Phase 4 Results FDA Drug FDA Device

• 1 other identifier: 20190014
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 12

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).

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Cycle 1: Day 1 to Day 3; Cycle 2: Day 1 and Day 2

Secondary Outcomes (4)

• Time to Therapeutic Intervention (TTI) During MDMP

  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)

  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

  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

  Up to a maximum of 193 days

Study Arms (1)

Blinatumomab

EXPERIMENTAL

Drug: Blinatumomab; Device: Current Wearable Heatlth Monitoring System (CWHMS)

Interventions

Blinatumomab DRUG

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.

Also known as: AMG 103, Blincyto

Blinatumomab

Current Wearable Heatlth Monitoring System (CWHMS) DEVICE

The study will use the CWHMS device to monitor participants' vital signs while they are at home.

Blinatumomab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (12)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

University of California Irvine

Orange, California, 92868-3201, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando

Orlando, Florida, 32804, United States

Location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Saint Francis Hospital, Inc

Greenville, South Carolina, 29607, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neoplasm, Residual

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 10, 2020
• Study Start: August 26, 2021
• Primary Completion: July 4, 2024
• Study Completion: September 16, 2024
• Last Updated: May 18, 2025
• Results First Posted: May 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (12)