2 Participants Needed

BLINCYTO for Leukemia

SP
AE
Overseen ByAshkan Emadi, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Maryland, Baltimore
Must be taking: Intrathecal chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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

What data supports the effectiveness of the drug Blincyto for leukemia?

Research shows that Blincyto (Blinatumomab) can help about 33% of patients with a specific type of leukemia (acute lymphoblastic leukemia) achieve complete remission, meaning their cancer is no longer detectable.12679

Who Is on the Research Team?

Dr. Vu Hong Duong, MD | University of ...

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

Direct bilirubin ≤ 2.5 mg/dL
I am of childbearing age and have a negative pregnancy test.
Ability to understand and willingness to sign a written informed consent document
See 10 more

Exclusion Criteria

My acute leukemia has specific genetic changes.
I have a very high white blood cell count but can take hydroxyurea for it.
I do not have any severe illnesses that my doctor thinks would interfere with the study.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive blinatumomab by continuous IV infusion for 28 days followed by a 14±3 days treatment-free interval

6 weeks

Consolidation

Participants continue to receive blinatumomab by continuous IV infusion for 28 days followed by a 28±3 days treatment-free interval

8 weeks

Maintenance

Participants receive blinatumomab by continuous IV infusion for 28 days followed by a 56±3 days treatment-free interval

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Blinatumomab
Trial Overview The trial is testing the effectiveness of blinatumomab for patients with specific types of acute leukemia that are either not responding to standard treatments or have lingering cancer cells post-treatment. The study focuses on how well this drug can treat these conditions.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Subjects with R/R CD19-positive MPALExperimental Treatment1 Intervention
Group II: Subjects with CD19-positive MPAL in CR/CRh/CRi/CRp and detectable MRDExperimental Treatment1 Intervention

Blinatumomab is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Blincyto for:
🇺🇸
Approved in United States as Blincyto for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials
729
Recruited
540,000+

Published Research Related to This Trial

Blinatumomab (Blincyto) achieved a complete remission in 33% of patients with relapsed or refractory Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL), indicating its efficacy as a treatment option.
However, the treatment is associated with frequent grade 3 or 4 adverse effects, highlighting the need for careful monitoring of patients during therapy.
Blinatumomab (Blincyto) for acute lymphoblastic leukemia.[2015]
Blinatumomab (Blincyto®) is an effective treatment for relapsed or refractory acute lymphoblastic leukemia, having received accelerated approval for its use.
A multidisciplinary collaboration among nursing, pharmacy, prescribers, and support staff is essential for the safe administration of blinatumomab, and this approach can be adapted by other institutions.
A Multidisciplinary Approach to Standardizing Processes for Blinatumomab Administration.DePadova, S., Howlett, C., Rivera, K.[2017]
Blinatumomab is an effective treatment for patients with relapsed or refractory Philadelphia chromosome-negative B-cell acute lymphocytic leukemia (ALL), as demonstrated in two phase II clinical trials.
Patients who achieve remission with blinatumomab may be eligible for stem cell transplantation, offering a potential cure for their leukemia.
Blinatumomab: A New Treatment for Adults With Relapsed Acute Lymphocytic Leukemia.Turner, J., Schneider, SM.[2017]

Citations

Blinatumomab (Blincyto) for acute lymphoblastic leukemia. [2015]
A Multidisciplinary Approach to Standardizing Processes for Blinatumomab Administration. [2017]
Blinatumomab: A New Treatment for Adults With Relapsed Acute Lymphocytic Leukemia. [2017]
Blinatumomab: first global approval. [2020]
Immunoglobulin repletion during blinatumomab therapy does not reduce the rate of secondary hypogammaglobulinemia and associated infectious risk. [2022]
The safety of blinatumomab in pediatric patients with acute lymphoblastic leukemia: A systematic review and meta-analysis. [2022]
FDA Approval: Blinatumomab. [2021]
Blinatumomab, a bispecific B-cell and T-cell engaging antibody, in the treatment of B-cell malignancies. [2020]
A closer look at blinatumomab. [2018]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security