Blinatumomab + Chemotherapy for Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates the effectiveness of blinatumomab, a monoclonal antibody therapy, combined with chemotherapy in treating a specific type of leukemia or lymphoma. The researchers aim to determine if this combination is more effective at killing cancer cells than chemotherapy alone, particularly in newly diagnosed patients with B-lymphoblastic leukemia or lymphoma, with or without Down syndrome. Those diagnosed with these conditions who have not yet undergone treatment might be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, providing an opportunity to access potentially effective treatment early.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that patients should not have received prior cytotoxic chemotherapy for their current diagnosis. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that blinatumomab is generally safe, with manageable side effects. Some patients have experienced longer hospital stays, but most tolerate the treatment well. Serious side effects can include infections, low white blood cell counts (which make it harder to fight infections), and liver issues.
Doctors are familiar with the chemotherapy drugs used in this trial, as they have treated cancer for a long time. These drugs can cause side effects like nausea, tiredness, and low blood counts, but these are familiar and usually manageable.
Since this trial is in a later phase, evidence already exists regarding the safety of these treatments. This suggests that blinatumomab and the chemotherapy drugs should be relatively safe for participants, though monitoring for side effects remains important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about blinatumomab for leukemia because it has a unique way of targeting cancer cells. Unlike traditional chemotherapy that attacks rapidly dividing cells broadly, blinatumomab is a type of immunotherapy known as a bispecific T-cell engager. It works by connecting cancerous B-cells with T-cells, essentially redirecting the body's own immune system to attack the leukemia cells. This targeted approach could potentially lead to fewer side effects and improved effectiveness compared to conventional treatments like vincristine or doxorubicin.
What evidence suggests that this trial's treatments could be effective for leukemia?
Research has shown that blinatumomab may effectively treat B-cell acute lymphoblastic leukemia (B-ALL). In previous studies, children who received blinatumomab with standard chemotherapy had a significantly better chance of remaining disease-free. In some trials, many patients achieved complete remission, with no cancer cells detected in their blood. One study found that 87.2% of patients reached minimal residual disease (MRD) negativity after two cycles of blinatumomab. In this trial, participants will be assigned to different treatment arms, some including blinatumomab with chemotherapy. These findings suggest that blinatumomab, particularly when combined with chemotherapy, could effectively combat leukemia.46789
Who Is on the Research Team?
Sumit Gupta
Principal Investigator
Children's Oncology Group
Are You a Good Fit for This Trial?
This trial is for patients with newly diagnosed B-lymphoblastic leukemia/lymphoma, including those with Down syndrome. Participants must meet specific age and white blood cell count criteria and have not received prior cytotoxic chemotherapy (except certain steroids or intrathecal cytarabine). Exclusions include CNS3/testicular leukemia, secondary ALL from previous cancer treatment, Burkitt B-cell ALL, pregnancy, lactation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Patients receive a combination of chemotherapy drugs including cytarabine, vincristine, dexamethasone, pegaspargase, and methotrexate. Treatment continues for 35 days.
Consolidation
Patients receive further chemotherapy to consolidate remission, including drugs like vincristine, mercaptopurine, and methotrexate. Treatment continues for 28-56 days depending on risk stratification.
Interim Maintenance
Patients receive vincristine and methotrexate with leucovorin rescue. Treatment continues for 56 days.
Delayed Intensification
Patients receive intensified chemotherapy including methotrexate, dexamethasone, vincristine, doxorubicin, pegaspargase, cyclophosphamide, thioguanine, and cytarabine. Treatment continues for 56 days.
Maintenance
Patients receive maintenance therapy with vincristine, dexamethasone, mercaptopurine, and methotrexate. Treatment repeats every 84 days until a total duration of therapy of 2 years from start of Interim Maintenance I is reached.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Follow-up occurs every 4 weeks until blood count recovery, then every 3 months for the first 2 years, every 4-6 months for the 3rd year, and every 6-12 months for the 4th and 5th years.
What Are the Treatments Tested in This Trial?
Interventions
- Asparaginase Erwinia chrysanthemi
- Blinatumomab
- Cyclophosphamide
- Cytarabine
- Dexamethasone
- Doxorubicin Hydrochloride
- Leucovorin Calcium
- Mercaptopurine
- Methotrexate
- Pegaspargase
- Prednisolone
- Prednisone
- Radiation Therapy
- Vincristine Sulfate
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor