Blinatumomab + Chemotherapy for Leukemia
Trial Summary
What is the purpose of this trial?
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it does mention that patients should not have received chemotherapy for B-ALL, except for up to five days of certain medications like hydroxyurea or steroids before starting the trial.
What data supports the effectiveness of the drug Blinatumomab in treating leukemia?
Blinatumomab has been shown to improve survival and complete remission rates in patients with relapsed or refractory acute lymphoblastic leukemia (ALL) compared to standard chemotherapy. In clinical trials, patients treated with Blinatumomab had a median survival of 7.7 months versus 4.0 months with standard chemotherapy, and a higher complete remission rate of 34% compared to 16% with standard treatment.12345
Is Blinatumomab safe for use in humans?
Blinatumomab has been tested in various clinical trials and is generally considered safe, but it can cause some serious side effects like cytokine release syndrome (a severe immune reaction) and neurological issues (problems with the brain and nerves). These side effects are usually manageable with proper medical care.16789
What makes the drug Blinatumomab unique for treating leukemia?
Blinatumomab is unique because it is a bispecific T-cell engager that targets CD19 on leukemia cells and activates T-cells to destroy them, offering a novel approach compared to traditional chemotherapy. It is administered through continuous 28-day infusion cycles, which is different from standard chemotherapy schedules.110111213
Research Team
Yishai Ofran
Principal Investigator
ECOG-ACRIN Cancer Research Group
Eligibility Criteria
Adults aged 18-75 with newly diagnosed BCR-ABL-positive acute lymphoblastic leukemia (ALL) can join this trial. They should be in decent physical shape, not pregnant or breastfeeding, and willing to use contraception. People with active brain involvement by leukemia, unstable epilepsy, other cancers, or those who have already started certain treatments for ALL are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-Induction
Patients receive prednisone and a tyrosine kinase inhibitor (TKI) for 21 days
Induction Therapy
Patients receive induction therapy with either chemotherapy or blinatumomab, along with steroids and TKI
Re-Induction
Patients who remain MRD positive receive re-induction therapy based on their initial treatment arm
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Blinatumomab
- Cyclophosphamide
- Cytarabine
- Dasatinib
- Dexamethasone
- Doxorubicin Hydrochloride
- Mesna
- Methotrexate
- Ponatinib Hydrochloride
- Prednisone
- 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