Chemotherapy + Immunotherapy for Acute Lymphoblastic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments for people with acute lymphoblastic leukemia, a type of blood cancer. It compares standard chemotherapy alone to chemotherapy combined with an immunotherapy drug called blinatumomab (Blincyto), which aids the immune system in fighting cancer. The goal is to determine if adding blinatumomab improves outcomes. Individuals newly diagnosed with the B lineage type of this leukemia and who are Philadelphia chromosome-negative, meaning they lack a specific genetic marker, may be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that hydroxyurea and corticosteroids can be used before starting the trial to control symptoms. It's best to discuss your current medications with the study team to get specific guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that blinatumomab, the immunotherapy drug studied in this trial, is generally safe for most people. In real-world settings, about 12.5% of patients reported serious side effects, indicating that most did not experience severe problems.
Blinatumomab has been effective in other studies for patients with B-cell acute lymphoblastic leukemia (ALL), a different type of blood cancer. This is encouraging as it suggests the drug can be safely used for similar conditions.
Since this trial is in a late phase, earlier studies have already tested blinatumomab for safety. This phase focuses more on confirming its effectiveness, indicating a good level of confidence in its safety.
The chemotherapy drugs used in this trial, such as cyclophosphamide and methotrexate, are well-known treatments with proven safety records from other cancer treatments. While chemotherapy can have side effects, healthcare providers generally understand and manage these well.12345Why do researchers think this study treatment might be promising for acute lymphoblastic leukemia?
Researchers are excited about combining chemotherapy with blinatumomab for treating Acute Lymphoblastic Leukemia (ALL) because blinatumomab introduces a novel mechanism of action. Unlike standard chemotherapy drugs that target rapidly dividing cells, blinatumomab is a type of immunotherapy that engages the body's own immune system to identify and attack leukemia cells. This dual approach not only aims to enhance the effectiveness of treatment but also has the potential to reduce the typical side effects associated with chemotherapy alone. By harnessing the power of the immune system, this combination could offer a more targeted and potentially more effective treatment option for patients with ALL.
What evidence suggests that this trial's treatments could be effective for acute lymphoblastic leukemia?
Research has shown that adding blinatumomab to chemotherapy can help treat B-cell acute lymphoblastic leukemia (B-ALL). One study found that 78% of patients had no detectable cancer cells after just one cycle of blinatumomab, achieving MRD (minimal residual disease) negativity. For children whose B-ALL returned, blinatumomab improved their outcomes. Specifically, out of 70 children treated, 39% achieved complete remission, with no signs of cancer found. In this trial, one group of participants will receive blinatumomab alongside chemotherapy, while another group will receive chemotherapy alone. These results suggest that combining blinatumomab with chemotherapy may enhance cancer treatment effectiveness for people with B-ALL.56789
Who Is on the Research Team?
Mark R Litzow
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
Adults aged 30-70 with a new diagnosis of BCR-ABL-negative B lineage acute lymphoblastic leukemia (ALL) are eligible. They must have normal kidney and liver function, not be pregnant or breastfeeding, use contraception if necessary, and have no recent severe heart issues. HIV-positive patients can join under certain conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Chemotherapy
Patients receive a combination of chemotherapy drugs including cytarabine, daunorubicin, vincristine, dexamethasone, methotrexate, and pegaspargase.
Intensification Therapy
Patients receive high-dose methotrexate and pegaspargase to intensify treatment.
Consolidation Therapy
Patients receive cytarabine, etoposide, methotrexate, and pegaspargase to consolidate treatment gains.
Maintenance Therapy
Patients receive mercaptopurine, methotrexate, vincristine, and prednisone to maintain remission.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Blinatumomab
- Cyclophosphamide
- Daunorubicin
- Dexamethasone
- Etoposide
- Mercaptopurine
- Methotrexate
- Prednisone
- Rituximab
- Vincristine
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Canadian Cancer Trials Group
Collaborator