BLINCYTO for Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a research study to find out if a drug called blinatumomab is effective for treating patients with relapsed or refractory (R/R) or measurable residual disease (MRD) CD19-positive mixed phenotypic acute leukemia (MPAL). Measurable Residual Disease (MRD) means that there are a small number of cancer cells remaining after treatment
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on other investigational drugs, chemotherapy, radiation, or immunotherapy (except corticosteroids or hydroxyurea). It's best to discuss your current medications with the study team.
Is Blincyto (Blinatumomab) safe for humans?
Blincyto (Blinatumomab) has been associated with serious side effects like cytokine release syndrome (a severe immune reaction) and neurologic events (problems with the nervous system), as well as common side effects like fever, headache, and nausea. It is important to discuss these risks with your healthcare provider.12345
What makes the drug Blinatumomab (Blincyto) unique for treating leukemia?
Blinatumomab (Blincyto) is unique because it is a bispecific T-cell engaging antibody that connects T-cells to cancer cells, specifically targeting CD19 antigens on leukemia cells, which helps the immune system destroy them. This mechanism is different from traditional chemotherapy and is particularly used for patients with relapsed or hard-to-treat acute lymphoblastic leukemia.12678
Who Is on the Research Team?
Vu H Duong, MD
Principal Investigator
University of Maryland, Baltimore
Are You a Good Fit for This Trial?
Adults with relapsed or refractory CD19-positive mixed phenotypic acute leukemia (MPAL) or those in remission but with detectable cancer cells after treatment. Participants must be over 18, have stable vital organ functions, and women of childbearing age must test negative for pregnancy. Those who've had a stem cell transplant should be past certain recovery milestones.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive blinatumomab by continuous IV infusion for 28 days followed by a 14±3 days treatment-free interval
Consolidation
Participants continue to receive blinatumomab by continuous IV infusion for 28 days followed by a 28±3 days treatment-free interval
Maintenance
Participants receive blinatumomab by continuous IV infusion for 28 days followed by a 56±3 days treatment-free interval
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Blinatumomab
Blinatumomab is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor