Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (… (NCT04506086) | Clinical Trial Compass
TerminatedPhase 4
Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)
Stopped: The decision to terminate is not based on safety or efficacy but due to slow enrollment impacting the ability to complete the study as planned.
United States10 participantsStarted 2021-08-26
Plain-language 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).
Who can participate
Age range18 Years – 99 Years
SexALL
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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 child…
What they're measuring
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
Timeframe: Cycle 1: Day 1 to Day 3; Cycle 2: Day 1 and Day 2