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New treatment option for CD19 Positive
Official title Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL)
ClinicalTrials.gov ID: NCT07222579
What this study is testing
What is Subcutaneous Blinatumomab?
Subcutaneous Blinatumomab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for cd19 positive.
Also referred to as Blincyto®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General Criteria for all three Cohorts
- people must have histologically or cytologically confirmed MPAL based on 2022 WHO criteria
- people 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...
- people with a CNS leukemia must be clinically stable (i.e., asymptomatic with no focal neurological signs and symptoms, or signs and symptoms...
- Ability to understand and willingness to sign a written informed consent document
You likely can't join if
- Criteria for all three Cohorts
- people receiving any other investigational agents, or concurrent chemotherapy, radiation therapy, or immunotherapy for cancer treatment not including...
- Active, uncontrolled infection; people with infection under active treatment and controlled with antimicrobials are eligible
See the full eligibility criteria
- General Criteria for all three Cohorts
- people must have histologically or cytologically confirmed MPAL based on 2022 WHO criteria
- people 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...
- people 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...
- 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
- people with hematologic malignancies are expected to have hematologic abnormalities at study entry
- Specific Criteria for Cohort A o people 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...
- 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
- people 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...
- ECOG performance status ≤2
- people 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
- Criteria for all three Cohorts
- people receiving any other investigational agents, or concurrent chemotherapy, radiation therapy, or immunotherapy for cancer treatment not including corticosteroids or hydroxyurea
- Active, uncontrolled infection; people with infection under active treatment and controlled with antimicrobials are eligible
The study team makes the final eligibility decision.
Where it's taking place
- Morgantown, West Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Morgantown, West Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.