Subcutaneous Blinatumomab for CD19-Positive MPAL
This study is testing a drug called blinatumomab, given as a shot under the skin, for adults with CD19-positive Mixed Phenotype Acute Leukemia (MPAL). This type of leukemia has features of both lymphoid and myeloid cells. The study is looking at how well blinatumomab works in different groups of patients: those newly diagnosed who can't have strong chemotherapy, and those who have already had treatment but still have some leukemia cells (minimal residual disease). Success will be measured by how many patients achieve complete remission, meaning no signs of leukemia, and how long they live. The study plans to enroll 78 participants, but its current status is unclear.
- Study design
- This is a Phase 2, multicenter study that is not randomized and is open-label, meaning everyone knows what treatment is being given. It plans to enroll 78 adult participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- For some participants, overall survival will be measured for up to 3 years after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ashkan Emadi, MD · PRINCIPAL_INVESTIGATOR · WVU Cancer Institute
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Cohort A - Overall SurvivalUp 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) negativityAt 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)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.