Immunotherapy + Chemotherapy for Acute Lymphoblastic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment combining inotuzumab ozogamicin and chemotherapy for elderly patients with acute lymphoblastic leukemia. The drug targets and kills cancer cells, aiming to improve outcomes for those who can't undergo intensive therapy or have had a recurrence. The study will determine the appropriate dose and evaluate the treatment's effectiveness and side effects.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the combination of immunotherapy and chemotherapy safe for treating acute lymphoblastic leukemia?
Blinatumomab, a type of immunotherapy, has been shown to be generally well-tolerated in patients with acute lymphoblastic leukemia, though it can cause side effects like cytokine release syndrome (a reaction where the immune system releases too many proteins into the blood too quickly) and neurological issues such as seizures. These side effects are usually manageable with treatment adjustments or medications like steroids.12345
What makes this drug combination unique for treating acute lymphoblastic leukemia?
This drug combination is unique because it combines immunotherapy drugs like blinatumomab and inotuzumab ozogamicin, which help the immune system target cancer cells, with traditional chemotherapy drugs. This approach may improve outcomes for patients with relapsed or hard-to-treat acute lymphoblastic leukemia by enhancing the effectiveness of treatment while potentially reducing the need for more toxic chemotherapy.16789
What data supports the effectiveness of the drug combination used in the Immunotherapy + Chemotherapy for Acute Lymphoblastic Leukemia trial?
Research shows that blinatumomab, one of the drugs in the trial, improved survival in patients with relapsed or refractory acute lymphoblastic leukemia, with a median overall survival of 7.7 months compared to 4.0 months with traditional chemotherapy. Additionally, inotuzumab ozogamicin, another drug in the trial, has shown effectiveness when combined with low-intensity chemotherapy in improving outcomes for patients with relapsed acute lymphoblastic leukemia.1791011
Who Is on the Research Team?
Elias Jabbour, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients aged 60+ with untreated acute lymphoblastic leukemia (ALL), including those unfit for intensive chemotherapy due to comorbidities like heart or kidney disease. It's also open to any age with refractory-relapsed ALL, certain high-grade B-cell lymphomas, and marrow involvement. Excluded are those with newly diagnosed Burkitt's Leukemia/Lymphoma, T-cell ALL/lymphoma, active heart disease, ejection fraction <40%, active hepatitis, or who are pregnant/breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive inotuzumab ozogamicin in combination with low-intensity chemotherapy, including cyclophosphamide, vincristine, dexamethasone, methotrexate, and cytarabine, across multiple cycles
Maintenance Therapy
Participants receive mercaptopurine, methotrexate, vincristine, prednisone, and blinatumomab over a long-term period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Blinatumomab
- Cyclophosphamide
- Cytarabine
- Dexamethasone
- Inotuzumab Ozogamicin
- Mercaptopurine
- Methotrexate
- Prednisone
- Rituximab
- Vincristine
Blinatumomab is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator