Actively Recruiting
Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL)
Led by West Virginia University · Updated on 2026-04-13
78
Participants Needed
1
Research Sites
289 weeks
Total Duration
On this page
Sponsors
W
West Virginia University
Lead Sponsor
A
Amgen
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, non-randomized, open-label, phase II study evaluating blinatumomab administered subcutaneously in adult subjects with CD19+ MPAL. This trial consists of three cohorts of patients with CD19-positive MPAL, categorized as follows: 1. Cohort A: Newly diagnosed CD19+ MPAL in untreated patients who are either ≥ 75 years of age or have at least one coexisting condition precluding intensive chemotherapy. 2. Cohort B: Patients with CD19+ MPAL who have achieved complete remission (CR, CRh, or CRi) following at least one line of treatment but have detectable measurable residual disease (MRD) at a level of ≥ 0.1%, assessed using an assay with a minimum sensitivity of 0.01%. 3. Cohort C: Patients with CD19+ MPAL with morphologic relapsed or refractory (R/R) disease following at least one prior line of treatment. The Primary Objectives for each cohort are for Cohort A: to evaluate the efficacy of SC-blinatumomab in treatment; for Cohort B: to assess the ability of SC-blinatumomab to achieve MRD-negative CR; for Cohort C: to determine the efficacy of SC-blinatumomab in inducing CR, CRh, or CRi in patients. At specified time points, subjects will undergo the following procedures: collection of informed consent, medical history, demographics, ECOG performance, and physical exam including vital signs as well as neurological examination including examination of writing ability. Subjects will provide samples for complete blood count with differential and blood chemistry profile, have a bone marrow aspiration and biopsy and lumbar puncture will be performed per protocol or if clinically indicated, and/or ECG, Echocardiography, pulmonary function test will be performed only if medically indicated. The subcutaneous treatment will be given in both the inpatient and outpatient setting. For an individual subject the length of participation includes up to a 3-week screening period, up to a 13-month treatment period, and a safety follow-up visit (30 days after the last dose of study treatment), and a follow-up period.
CONDITIONS
Official Title
Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed MPAL based on 2022 WHO criteria
- Subjects who had allo-HSCT are eligible if at least 4 weeks post stem cell infusion, no GVHD > Grade 2, and at least 1 week off immunosuppressive therapy
- For patients with CNS leukemia, must be clinically stable with clear CSF flow cytometry within 2 weeks before treatment
- Ability to understand and sign informed consent
- Agree to comply with study requirements and attend clinic visits
- Expected to have hematologic abnormalities at study entry
- Cohort A: Age 75 years or older or have coexisting conditions precluding intensive chemotherapy such as CHF requiring treatment or EF ≤50% in past 12 months, chronic stable angina, DLCO ≤65% or FEV1 ≤65% in past 12 months, ECOG performance status 3 or 4, or Charlson comorbidity index ≥3
- Cohort B: CD19+ MPAL in CR/CRh/CRi after at least one treatment line with MRD ≥0.1% by sensitive assay
- Cohort B: ECOG performance status ≤2
- Cohort B: Organ function with direct bilirubin ≤2.5 mg/dL, AST/ALT/alkaline phosphatase ≤5 times upper limit of normal, serum creatinine ≤3 mg/dL
- Cohort C: Confirmed relapsed/refractory CD19+ MPAL
- Cohort C: Prior cytotoxic chemotherapy completed by 5 half-lives before treatment start and recovery to ≤ Grade 1 toxicities
- Cohort C: ECOG performance status ≤2
- Cohort C: Organ function with direct bilirubin ≤2.5 mg/dL, AST/ALT/alkaline phosphatase ≤5 times upper limit of normal, serum creatinine ≤3 mg/dL
You will not qualify if you...
- Receiving other investigational agents or concurrent chemotherapy, radiation, or immunotherapy except corticosteroids or hydroxyurea
- Active, uncontrolled infection (patients with controlled infection under treatment are eligible)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West Virginia University Cancer Institute
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
A
Ashkan Emadi, MD
CONTACT
L
Lindsay Carter
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here