Trial · NCT07222579
Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL)
NCT07222579, Phase 2, Recruiting, West Virginia University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL). Trials, record NCT07222579. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07222579
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL)
- NCT number
- NCT07222579
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 78 participants, estimated
- Lead sponsor
- West Virginia University
- Conditions
- CD19 Positive, Mixed Phenotype Acute Leukemia (MPAL)
- Interventions
- Subcutaneous Blinatumomab
- First posted
- 2025-10-30
- Last updated
- 2026-04-13
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohort A - Overall Survival | Up to 3 years | The Overall Survival (OS) is the time from treatment initiation to death from any cause. |
| Primary | 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 | 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. |
| Primary | Cohort C - Rate of Complete Remission (CR) or Complete Remission with Partial Hematological Recovery (CRh) | 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. |
| Secondary | Cohort A - MRD-negative CR + CRh rate | At completion of 2 cycles (each cycle is 34 days) | 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. |
| Secondary | Cohort A - Event-Free Survival (EFS) | Up to approximately 3 years | 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 |
| Secondary | Cohort A - Incidence and Severity of Adverse Events (AEs) | Up to approximately 1 year | 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). |
| Secondary | Cohort B - Overall Survival | Up to approximately 3 years | The Overall Survival (OS)is the time from treatment initiation to death from any cause. |
| Secondary | Cohort B - Rate of MRD-negativity (<0.01%) | At completion of 1 cycle (cycle is 34 days) | 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. |
| Secondary | Cohort B - Event-Free Survival (EFS) | Up to approximately 1 year | 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 |
| Secondary | Cohort B - Incidence and Severity of Adverse Events (AEs) | Up to approximately 1 year | 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). |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07222579
GET https://conductscience.org/api/trials/v1/NCT07222579/registered