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NCT07222579 · ClinicalTrials.gov registry record · Phase 2
Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL)
A Phase 2 study of CD19 Positive and Mixed Phenotype Acute Leukemia (MPAL), sponsored by West Virginia University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT07222579: Recruiting Phase 2 study of CD19 Positive and Mixed Phenotype Acute Leukemia (MPAL), sponsored by West Virginia University.
NCT07222579 is a Phase 2 study of CD19 Positive and Mixed Phenotype Acute Leukemia (MPAL) that is actively recruiting participants, run by West Virginia University. The registered enrollment target is 78 participants, above the 37-participant average among 4 other CD19 Positive trials with a reported enrollment target (111% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07222579, a Phase 2 study of CD19 Positive and Mixed Phenotype Acute Leukemia (MPAL), is actively recruiting participants, sponsored by West Virginia University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Primary Outcome
The Overall Survival (OS) is the time from treatment initiation to death from any cause.
Conditions Studied
Interventions
- DRUG Subcutaneous Blinatumomab
Study Locations (1)
West Virginia
- West Virginia University Cancer Institute - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2026-02 |
| Est. Completion | 2031-08 |
| Phase | Phase 2 |
What NCT07222579 shows while recruiting
NCT07222579 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, above the 37-participant average among 4 other CD19 Positive trials with a reported enrollment target (111% higher).
The record links to 2 conditions, with CD19 Positive appearing as the primary indexed condition, and to 1 intervention - of which Subcutaneous Blinatumomab is the first listed.
NCT07222579 reports a single indexed study location in West Virginia.
Frequently Asked Questions
What is clinical trial NCT07222579 about?
NCT07222579 is a clinical study titled "Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL)". 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 untrea...
What is the current status of trial NCT07222579?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2026-02. Estimated completion is 2031-08.
What conditions does trial NCT07222579 study?
This clinical trial studies the following conditions: CD19 Positive, Mixed Phenotype Acute Leukemia (MPAL).
What interventions are being tested in trial NCT07222579?
The interventions under investigation include: Subcutaneous Blinatumomab (DRUG).
Who is sponsoring clinical trial NCT07222579?
This trial is sponsored by West Virginia University, which has 122 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07222579 being conducted?
This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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