Blinatumomab for Acute Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called blinatumomab, a type of immunotherapy, for CD19-positive MPAL, a form of acute leukemia. The goal is to evaluate the drug's effectiveness in various groups: newly diagnosed patients unable to tolerate strong chemotherapy, those in remission but still showing disease signs, and patients whose leukemia has returned or is unresponsive to treatment. Suitable candidates include individuals with CD19-positive MPAL who meet specific health criteria, such as being 75 or older or having other health issues that make intense chemotherapy unsafe. Participants will receive the treatment through a subcutaneous injection and will attend both hospital and clinic visits for health monitoring. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in leukemia care.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot be on other investigational agents, chemotherapy, radiation, or immunotherapy for cancer treatment, except for corticosteroids or hydroxyurea. If you have had previous chemotherapy, it must be completed by 5 half-lives of the drug(s) before starting the trial.
Is there any evidence suggesting that blinatumomab is likely to be safe for humans?
Studies have shown that blinatumomab is generally well-tolerated in people with B cell acute lymphoblastic leukemia, a type of blood cancer. Many patients have received blinatumomab, and it has proven effective both as an initial treatment and when the disease recurs after treatment.
Research indicates that some patients experience side effects, such as fever, headache, and low blood cell counts. However, medical help often manages these side effects. Blinatumomab has already received FDA approval for certain uses, indicating that its safety has been thoroughly reviewed in other settings.
For those considering a trial with blinatumomab, studies suggest the possibility of side effects, but the treatment has been used safely in many people before. Always discuss any concerns with a healthcare provider.12345Why do researchers think this study treatment might be promising?
Unlike the standard chemotherapy treatments for acute leukemia, blinatumomab is a bispecific T-cell engager (BiTE) that uniquely targets the CD19 protein on leukemia cells. This mechanism allows it to harness the body's own immune system to attack cancer cells more directly and effectively. Researchers are particularly excited about the potential for blinatumomab to offer a less intensive treatment option, especially for older patients or those unfit for traditional chemotherapy, as it can be administered subcutaneously, potentially improving the quality of life during treatment. Additionally, blinatumomab's ability to target minimal residual disease (MRD) is promising for achieving deeper remissions in patients.
What evidence suggests that blinatumomab could be an effective treatment for CD19+ MPAL?
Research has shown that blinatumomab can help treat certain types of leukemia that have returned or are difficult to treat. In this trial, participants will join different cohorts to evaluate blinatumomab's efficacy in various contexts. Studies indicate that about 44% of patients respond well to blinatumomab, with an average survival time of 7.7 months. This treatment helps the body's immune system find and destroy cancer cells. For patients with ongoing cancer signs, blinatumomab has shown promise in lowering cancer levels. These findings suggest that blinatumomab can be a valuable option for those with challenging leukemia cases.12356
Who Is on the Research Team?
Ashkan Emadi, MD
Principal Investigator
WVU Cancer Institute
Are You a Good Fit for This Trial?
Adults with CD19-positive Mixed Phenotype Acute Leukemia (MPAL) who are either newly diagnosed and unfit for intensive chemo due to age/conditions, or have had some treatment but still show signs of leukemia, or whose disease has returned or resisted treatment. Participants must be able to perform basic daily activities with minimal assistance.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous blinatumomab in cycles, with each cycle lasting 34 days, including a 26-day treatment period and an 8-day treatment-free interval.
Safety Follow-up
A safety follow-up visit occurs 30 days after the last dose of study treatment to monitor for adverse events and overall health.
Follow-up
Participants are monitored for long-term outcomes, including overall survival and event-free survival.
What Are the Treatments Tested in This Trial?
Interventions
- Blinatumomab
Find a Clinic Near You
Who Is Running the Clinical Trial?
West Virginia University
Lead Sponsor
Amgen
Industry Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London