CD19 PositivePhase 2NCT07222579
Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL)
A Phase 2 study testing Subcutaneous Blinatumomab in people with CD19 Positive and Mixed Phenotype Acute Leukemia (MPAL), run by West Virginia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CD19 Positive, Mixed Phenotype Acute Leukemia (MPAL)
- What is being tested?
- Subcutaneous Blinatumomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2026to Aug 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Criteria for all three Cohorts
- Subjects must have histologically or cytologically confirmed MPAL based on 2022 WHO criteria
- Subjects who have undergone allo-HSCT are eligible if they are ≥ 4 weeks post stem cell infusion, have no evidence of GVHD > Grade 2, and are at least ≥ 1 week off of immunosuppressive therapy. Per FDA recommendation, patients should be off of calcineurin inhibitors (CNIs) for at least 4 weeks before receiving blinatumomab
- Subjects with a CNS leukemia must be clinically stable (i.e., asymptomatic with no focal neurological signs and symptoms, or signs and symptoms unchanged over 4 weeks with no > grade 2 manifestations) with a flow cytometric clear CSF in the 2 weeks prior to day 1 of SC-blinatumomab administration.
- Ability to understand and willingness to sign a written informed consent document
- Agree to comply with the study requirements and agree to come to the clinic/hospital for required study visits
Show all 24Show fewer
- Subjects with hematologic malignancies are expected to have hematologic abnormalities at study entry
- Specific Criteria for Cohort A
- o Subjects should be ineligible for available induction therapy either if they are 75 years of age or older or if they have at least one of the following coexisting conditions precluding intensive chemotherapy: a history of CHF for which treatment is warranted or a report of EF ≤50% in the last 12 months, a history of chronic stable angina, a report of DLCO of ≤65% or FEV1 ≤65% in the last 12 months, ECOG performance status 3 or 4, Charlson comorbidity index (CCI) ≥3.
- Specific Criteria for Cohort B
- CD19+ MPAL in CR/CRh/CRi after at least one line of treatment with MRD positivity at a level of ≥0.1% using an assay with a minimum sensitivity of 0.01%.
- ECOG performance status ≤2
- Subjects must have organ function as below:
- Direct bilirubin ≤ 2.5 mg/dL
- AST/ALT/Alkaline phosphatase ≤ 5 X institutional upper limit of normal
- Serum creatinine ≤ 3 mg/dL
- Specific Criteria for Cohort C
- Confirmed R/R CD19+ MPAL
- Previous cytotoxic chemotherapy (except for hydroxyurea) must have been completed by 5 half-lives of the drug(s) prior to day 1 of SC-blinatumomab. Per FDA recommendation, patients should have recovered to no more than Grade 1 toxicities from prior chemotherapy.
- ECOG performance status ≤2
- Subjects must have organ function as below:
- Direct bilirubin ≤ 2.5 mg/dL
- AST/ALT/Alkaline phosphatase ≤ 5 X institutional upper limit of normal
- Serum creatinine ≤ 3 mg/dL
Who cannot join
- Criteria for all three Cohorts
- Subjects receiving any other investigational agents, or concurrent chemotherapy, radiation therapy, or immunotherapy for cancer treatment not including corticosteroids or hydroxyurea
- Active, uncontrolled infection; subjects with infection under active treatment and controlled with antimicrobials are eligible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
West Virginia University Cancer Institute
Morgantown, West Virginia, 26506
Ashkan Emadi, MD, 304-598-6734, ashkan.emadi@hsc.wvu.edu
Lindsay Carter, 304-293-0220, lindsay.carter@hsc.wvu.edu
About this study
Official title: A Multicenter Phase II Study of 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 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.
- Being tested
- Subcutaneous Blinatumomab
- Medical subject headings
- Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous BlinatumomabDrug
Also called Blincyto®
Blinatumomab will be administered as a subcutaneous (SC) injection.
| Study group | Role | What they receive |
|---|---|---|
| Blinatumomab in Newly Diagnosed CD19+ MPAL, Age ≥ 75 or Unfit for Intensive Chemotherapy | Experimental | Cohort A: Evaluate the efficacy of SC-blinatumomab in treating newly diagnosed CD19+ MPAL in patients ≥ 75 years old or those deemed unfit for intensive chemotherapy.
* Each cycle = 34 days (26-day treatment period + 8-day treatment free interval between day 27 and day 34).
* Cycle 1 receives treatment daily during the first week and 3 times (TIW) weekly (M/W/F) during weeks 2-4.
* In subsequent cycles, the treatment will be administered TIW during weeks 1-4.
* All subjects will be hospitalized for days 1-12 of cycle 1.
* Other treatment doses will be given as outpatients. Subjects will remain in the outpatient department for 1-6 hours after each dose is given.
* Treatment will be given with ability to delay cycle initiation based on blood counts or general physical/neurological examination findings per clinical indication and institutional standard practice. Receives: Drug: Subcutaneous Blinatumomab |
| Blinatumomab use in CD19+ MPAL in first or second CR/CRh/CRi with detectable MRD ≥0.1% | Experimental | Cohort B: Assess the ability of SC-blinatumomab to achieve MRD-negative CR in patients with CD19+ MPAL in CR/CRh/CRi with persistent MRD positivity (≥ 0.1%) after at least one line of treatment.
* Each cycle = 34 days (26-day treatment period + 8-day treatment free interval between day 27 and day 34).
* Cycle 1 receives treatment daily during the first week and 3 times (TIW) weekly (M/W/F) during weeks 2-4.
* In subsequent cycles, the treatment will be administered TIW during weeks 1-4.
* All subjects will be hospitalized for days 1-12 of cycle 1.
* Other treatment doses will be given as outpatients. Subjects will remain in the outpatient department for 1-6 hours after each dose is given.
* Treatment will be given with ability to delay cycle initiation based on blood counts or general physical/neurological examination findings per clinical indication and institutional standard practice. Receives: Drug: Subcutaneous Blinatumomab |
| Blinatumomab use in Morphologic R/R CD19+ MPAL | Experimental | Cohort C: Determine the efficacy of SC-blinatumomab in inducing CR, CRh, or CRi in patients with morphologic relapsed or refractory CD19+ MPAL.
* Each cycle = 34 days (26-day treatment period + 8-day treatment free interval between day 27 and day 34).
* Cycle 1 receives treatment daily during the first week and 3 times (TIW) weekly (M/W/F) during weeks 2-4.
* In subsequent cycles, the treatment will be administered TIW during weeks 1-4.
* All subjects will be hospitalized for days 1-12 of cycle 1.
* Other treatment doses will be given as outpatients. Subjects will remain in the outpatient department for 1-6 hours after each dose is given.
* Treatment will be given with ability to delay cycle initiation based on blood counts or general physical/neurological examination findings per clinical indication and institutional standard practice. Receives: Drug: Subcutaneous Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort A - Overall Survival
The Overall Survival (OS) is the time from treatment initiation to death from any cause.
Measured: Up to 3 years
Cohort B - Rate of Complete Remission (CR), Complete Remission with Partial Hematological Recovery (CRh), or Complete Remission with Incomplete Hematological Recovery (CRi) with Minimal Residual Disease (MRD) negativity
The rate of achievement of complete remission (CR/CRh/CRi) with MRD-negativity (<0.01%) after the first two cycles of therapy with blinatumomab. CR: Bone marrow blasts <5%; absence of circulating blasts; absence of extramedullary disease; absolute neutrophil count (ANC) ≥1000/µL and platelets ≥100,000/µL; MRD+ or unknown. CR +CRh: Bone marrow blasts <5%; absence of circulating blasts; absence of extramedullary disease; ANC ≥500/µL AND platelet count ≥50,000/µL. CR +CRi: Bone marrow blasts <5%; absence of circulating blasts; absence of extramedullary disease; with residual thrombocytopenia (platelet count of <100,000/µL) OR residual neutropenia (ANC <1000/µL); not fulfilling criteria for CRh. MRD Negativity: No detectable cancer cells using sensitive tests, with less than 0.01% cancer cells. MRD positivity indicates a higher risk of relapse, while MRD negativity is linked to long-term remission and survival benefits.
Measured: At completion of 2 cycles (each cycle is 34 days)
Cohort C - Rate of Complete Remission (CR) or Complete Remission with Partial Hematological Recovery (CRh)
The rate of achievement of complete remission (CR/CRh) after the first two cycles of therapy with blinatumomab.
Complete Remission (CR): No detectable cancer cells in the bone marrow (less than 5% blast cells) and normal blood counts. CRh: No detectable cancer cells, with partial recovery of blood counts (ANC 500-1,000/µL, platelets 50,000-100,000/µL). The rate of achieving these states is calculated by the proportion of patients who reach CR/CRh within a set time. Higher rates of achievement indicate that a larger proportion of participants are responding positively to the treatment, with no detectable cancer cells in their bone marrow and recovery of blood counts.
Measured: At completion of 2 cycles (each cycle is 34 days)
Secondary outcomes (11)
Cohort A - MRD-negative CR + CRh rate
MRD-negative CR + CRh rate is the proportion of participants who achieve either Complete Remission (CR) or Complete Remission with Partial Hematological Recovery (CRh) and also have no detectable minimal residual disease (MRD) in bone marrow. Higher rates of MRD-negative CR + CRh indicate the treatment is highly effective in both inducing remission and reducing the risk of relapse.
Measured: At completion of 2 cycles (each cycle is 34 days)
Cohort A - Event-Free Survival (EFS)
Time from treatment initiation to the earliest occurrence of one of the following events:
- Failure to achieve CR, CRh, or CRi after at least two cycles of SC-blinatumomab
- Relapse after achieving CR, CRh, or CRi
- Initiation of new leukemia-directed therapy due to persistent disease or progression
- Death from any cause
Measured: Up to approximately 3 years
Cohort A - Incidence and Severity of Adverse Events (AEs)
The number of AE Incidences including the severity of those events. The descriptions and grading scales found in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, published on November 27, 2017, will be utilized for AE reporting. The general guidelines for each grade are Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).
Measured: Up to approximately 1 year
Cohort B - Overall Survival
The Overall Survival (OS)is the time from treatment initiation to death from any cause.
Measured: Up to approximately 3 years
Cohort B - Rate of MRD-negativity (<0.01%)
The rate of MRD-negativity (<0.01%) within one cycle of SC-blinatumomab treatment. MRD negativity means that the number of cancer cells is below the threshold of 0.01%. A higher rate of MRD negativity suggests that the treatment is highly effective in eliminating cancer cells and reducing the risk of relapse.
Measured: At completion of 1 cycle (cycle is 34 days)
Cohort B - Event-Free Survival (EFS)
Time from treatment initiation to the earliest occurrence of one of the following events:
- Failure to achieve CR, CRh, or CRi after at least two cycles of SC-blinatumomab
- Relapse after achieving CR, CRh, or CRi
- Initiation of new leukemia-directed therapy due to persistent disease or progression
- Death from any cause
Measured: Up to approximately 1 year
Cohort B - Incidence and Severity of Adverse Events (AEs)
The number of AE Incidences including the severity of those events. The descriptions and grading scales found in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, published on November 27, 2017, will be utilized for AE reporting. The general guidelines for each grade are Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).
Measured: Up to approximately 1 year
Cohort C - Overall Survival
The Overall Survival (OS)is the time from treatment initiation to death from any cause.
Measured: Up to approximately 3 years
Cohort C - Event-Free Survival (EFS)
Time from treatment initiation to the earliest occurrence of one of the following events:
- Failure to achieve CR, CRh, or CRi after at least two cycles of SC-blinatumomab
- Relapse after achieving CR, CRh, or CRi
- Initiation of new leukemia-directed therapy due to persistent disease or progression
- Death from any cause
Measured: Up to approximately 1 year
Cohort C - Incidence and Severity of Adverse Events (AEs)
The number of AE Incidences including the severity of those events. The descriptions and grading scales found in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, published on November 27, 2017, will be utilized for AE reporting. The general guidelines for each grade are Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).
Measured: Up to approximately 1 year
Overall - Incidence and Severity of Adverse Events (AEs)
The number of AE Incidences including the severity of those events. The descriptions and grading scales found in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, published on November 27, 2017, will be utilized for AE reporting. The general guidelines for each grade are Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).
Measured: Up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start15 Jan 2026
- Primary completionAug 2029 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD19 PositiveStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- * Cohort A: Participants with newly diagnosed CD19+ MPAL who are ≥ 75 years old or deemed unfit for intensive chemotherapy * Cohort B: Participants with CD19+ MPAL in first or second CR/CRh/CRi with detectable MRD ≥0.1% * Cohort C: Participants with morphologic R/R CD19+ MPAL
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Ashkan Emadi, MD PHD, West Virginia University
- Investigators
- Ashkan Emadi, MD, Principal investigator, WVU Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222579
- Sponsor's protocol ID
- 2506170190
- Status last verified
- Apr 2026
- First submitted
- 20 Oct 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Study of Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL)
- ClinicalTrials.gov ID
- NCT07222579
- Acronym / sponsor ID
- 2506170190
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 30 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- * Cohort A: Participants with newly diagnosed CD19+ MPAL who are ≥ 75 years old or deemed unfit for intensive chemotherapy * Cohort B: Participants with CD19+ MPAL in first or second CR/CRh/CRi with detectable MRD ≥0.1% * Cohort C: Participants with morphologic R/R CD19+ MPAL
| Arm | Type | Receives |
|---|---|---|
| Blinatumomab in Newly Diagnosed CD19+ MPAL, Age ≥ 75 or Unfit for Intensive Chemotherapy | Experimental | Drug: Subcutaneous BlinatumomabCohort A: Evaluate the efficacy of SC-blinatumomab in treating newly diagnosed CD19+ MPAL in patients ≥ 75 years old or those deemed unfit for intensive chemotherapy. * Each cycle = 34 days (26-day treatment period + 8-day treatment free interval between day 27 and day 34). * Cycle 1 receives treatment daily during the first week and 3 times (TIW) weekly (M/W/F) during weeks 2-4. * In subsequent cycles, the treatment will be administered TIW during weeks 1-4. * All subjects will be hospitalized for days 1-12 of cycle 1. * Other treatment doses will be given as outpatients. Subjects will remain in the outpatient department for 1-6 hours after each dose is given. * Treatment will be given with ability to delay cycle initiation based on blood counts or general physical/neurological examination findings per clinical indication and institutional standard practice. |
| Blinatumomab use in CD19+ MPAL in first or second CR/CRh/CRi with detectable MRD ≥0.1% | Experimental | Drug: Subcutaneous BlinatumomabCohort B: Assess the ability of SC-blinatumomab to achieve MRD-negative CR in patients with CD19+ MPAL in CR/CRh/CRi with persistent MRD positivity (≥ 0.1%) after at least one line of treatment. * Each cycle = 34 days (26-day treatment period + 8-day treatment free interval between day 27 and day 34). * Cycle 1 receives treatment daily during the first week and 3 times (TIW) weekly (M/W/F) during weeks 2-4. * In subsequent cycles, the treatment will be administered TIW during weeks 1-4. * All subjects will be hospitalized for days 1-12 of cycle 1. * Other treatment doses will be given as outpatients. Subjects will remain in the outpatient department for 1-6 hours after each dose is given. * Treatment will be given with ability to delay cycle initiation based on blood counts or general physical/neurological examination findings per clinical indication and institutional standard practice. |
| Blinatumomab use in Morphologic R/R CD19+ MPAL | Experimental | Drug: Subcutaneous BlinatumomabCohort C: Determine the efficacy of SC-blinatumomab in inducing CR, CRh, or CRi in patients with morphologic relapsed or refractory CD19+ MPAL. * Each cycle = 34 days (26-day treatment period + 8-day treatment free interval between day 27 and day 34). * Cycle 1 receives treatment daily during the first week and 3 times (TIW) weekly (M/W/F) during weeks 2-4. * In subsequent cycles, the treatment will be administered TIW during weeks 1-4. * All subjects will be hospitalized for days 1-12 of cycle 1. * Other treatment doses will be given as outpatients. Subjects will remain in the outpatient department for 1-6 hours after each dose is given. * Treatment will be given with ability to delay cycle initiation based on blood counts or general physical/neurological examination findings per clinical indication and institutional standard practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- General Criteria for all three Cohorts
- Specific Criteria for Cohort A
- o Subjects should be ineligible for available induction therapy either if they are 75 years of age or older or if they have at least one of the following coexisting conditions precluding intensive chemotherapy: a history of CHF for which treatment is warranted or a report of EF ≤50% in the last 12 months, a history of chronic stable angina, a report of DLCO of ≤65% or FEV1 ≤65% in the last 12 months, ECOG performance status 3 or 4, Charlson comorbidity index (CCI) ≥3.
- Specific Criteria for Cohort B
- Specific Criteria for Cohort C
Key exclusion criteria (3 listed)
- Criteria for all three Cohorts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous BlinatumomabAlso: Blincyto®Blinatumomab will be administered as a subcutaneous (SC) injection. | Drug | Blinatumomab in Newly Diagnosed CD19+ MPAL, Age ≥ 75 or Unfit for Intensive Chemotherapy, Blinatumomab use in CD19+ MPAL in first or second CR/CRh/CRi with detectable MRD ≥0.1%, Blinatumomab use in Morphologic R/R CD19+ MPAL |
Primary outcome
Cohort A - Overall Survival
Time frame: Up to 3 years
The Overall Survival (OS) is the time from treatment initiation to death from any cause.
Cohort B - Rate of Complete Remission (CR), Complete Remission with Partial Hematological Recovery (CRh), or Complete Remission with Incomplete Hematological Recovery (CRi) with Minimal Residual Disease (MRD) negativity
Time frame: At completion of 2 cycles (each cycle is 34 days)
The rate of achievement of complete remission (CR/CRh/CRi) with MRD-negativity (<0.01%) after the first two cycles of therapy with blinatumomab. CR: Bone marrow blasts <5%; absence of circulating blasts; absence of extramedullary disease; absolute neutrophil count (ANC) ≥1000/µL and platelets ≥100,000/µL; MRD+ or unknown. CR +CRh: Bone marrow blasts <5%; absence of circulating blasts; absence of extramedullary disease; ANC ≥500/µL AND platelet count ≥50,000/µL. CR +CRi: Bone marrow blasts <5%; absence of circulating blasts; absence of extramedullary disease; with residual thrombocytopenia (platelet count of <100,000/µL) OR residual neutropenia (ANC <1000/µL); not fulfilling criteria for CRh. MRD Negativity: No detectable cancer cells using sensitive tests, with less than 0.01% cancer cells. MRD positivity indicates a higher risk of relapse, while MRD negativity is linked to long-term remission and survival benefits.
Cohort C - Rate of Complete Remission (CR) or Complete Remission with Partial Hematological Recovery (CRh)
Time frame: At completion of 2 cycles (each cycle is 34 days)
The rate of achievement of complete remission (CR/CRh) after the first two cycles of therapy with blinatumomab. Complete Remission (CR): No detectable cancer cells in the bone marrow (less than 5% blast cells) and normal blood counts. CRh: No detectable cancer cells, with partial recovery of blood counts (ANC 500-1,000/µL, platelets 50,000-100,000/µL). The rate of achieving these states is calculated by the proportion of patients who reach CR/CRh within a set time. Higher rates of achievement indicate that a larger proportion of participants are responding positively to the treatment, with no detectable cancer cells in their bone marrow and recovery of blood counts.
11 secondary outcomes
Cohort A - MRD-negative CR + CRh rate
Time frame: At completion of 2 cycles (each cycle is 34 days)
Cohort A - Event-Free Survival (EFS)
Time frame: Up to approximately 3 years
Cohort A - Incidence and Severity of Adverse Events (AEs)
Time frame: Up to approximately 1 year
Cohort B - Overall Survival
Time frame: Up to approximately 3 years
Cohort B - Rate of MRD-negativity (<0.01%)
Time frame: At completion of 1 cycle (cycle is 34 days)
Cohort B - Event-Free Survival (EFS)
Time frame: Up to approximately 1 year
Cohort B - Incidence and Severity of Adverse Events (AEs)
Time frame: Up to approximately 1 year
Cohort C - Overall Survival
Time frame: Up to approximately 3 years
Cohort C - Event-Free Survival (EFS)
Time frame: Up to approximately 1 year
Cohort C - Incidence and Severity of Adverse Events (AEs)
Time frame: Up to approximately 1 year
Overall - Incidence and Severity of Adverse Events (AEs)
Time frame: Up to approximately 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashkan Emadi, MD principal investigator
WVU Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Subcutaneous Blinatumomab in people with CD19 Positive and Mixed Phenotype Acute Leukemia (MPAL), run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashkan Emadi, MD (304-293-5949, MPALStudyWVUCI@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort A - Overall Survival (time frame: Up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.