Blinatumomab + Chemotherapy/Dasatinib for Acute Lymphoblastic Leukemia
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, certain medications like proton pump inhibitors and some chemotherapy drugs must be stopped before registration. It's best to discuss your current medications with the study team to understand any specific requirements.
What data supports the effectiveness of the drug Blinatumomab for treating Acute Lymphoblastic Leukemia?
Blinatumomab has shown effectiveness in treating relapsed or refractory acute lymphoblastic leukemia (ALL), with clinical trials demonstrating higher complete remission rates and improved survival compared to standard chemotherapy. In the TOWER trial, patients receiving Blinatumomab had a 34% complete remission rate compared to 16% with standard chemotherapy, and a median survival of 7.7 months versus 4.0 months.12345
Is the combination of Blinatumomab and chemotherapy safe for treating acute lymphoblastic leukemia?
Blinatumomab, used in treating acute lymphoblastic leukemia, has shown some side effects like cytokine release syndrome (a severe immune reaction) and neurotoxicity (nerve damage), but these can be managed with strategies like premedication and dose adjustments. In trials, it was generally well-tolerated, and patients recovered from severe chemotherapy-related toxicity when treated with Blinatumomab.12567
What makes the drug combination of Blinatumomab and Dasatinib unique for treating acute lymphoblastic leukemia?
This drug combination is unique because it offers a chemotherapy-free option for treating Philadelphia chromosome-positive acute lymphoblastic leukemia, with Blinatumomab engaging the immune system to target cancer cells and Dasatinib inhibiting cancer cell growth. This approach can lead to significant molecular responses with potentially fewer toxicities compared to traditional chemotherapy.12489
What is the purpose of this trial?
This phase II trial studies the side effects and how well blinatumomab and combination chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as prednisone, vincristine sulfate, methotrexate, and mercaptopurine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and prednisone may kill more cancer cells.
Research Team
Anjali S Advani
Principal Investigator
SWOG Cancer Research Network
Eligibility Criteria
This trial is for older patients (65+) with acute lymphoblastic leukemia (ALL), including those with Philadelphia chromosome positive ALL or Ph-like DSMKF. It's suitable for newly diagnosed, relapsed, or refractory cases. Participants must have a certain percentage of lymphoblasts in blood/marrow and be able to provide consent for immunogenicity testing. Exclusions include CNS3 status, Burkitt's leukemia, prior significant treatments for ALL within specific time frames before registration, uncontrolled infections, and other serious health conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction
Patients receive blinatumomab or dasatinib and prednisone based on cohort assignment
Re-Induction
Patients not achieving CR or CRi receive additional blinatumomab treatment
Post-Remission
Patients receive blinatumomab and dasatinib treatment based on cohort assignment
Maintenance
Patients receive POMP or dasatinib and prednisone treatment based on cohort assignment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Blinatumomab
- Dasatinib
- Mercaptopurine
- Methotrexate
- Prednisone
- Vincristine
- Vincristine Sulfate
Blinatumomab is already approved in European Union, United States for the following indications:
- Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
- High-risk first relapse BCP-ALL
- Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
- First or second complete remission with minimal residual disease (MRD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor