Chemotherapy + Targeted Therapy for Acute Lymphoblastic Leukemia
Trial Summary
What is the purpose of this trial?
This phase II clinical trial tests a chemotherapy regimen (dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin with or without rituximab \[DA-EPOCH+/-R\]) with the addition of targeted therapy (tafasitamab) for the treatment of patients with newly diagnosed Philadelphia chromosome negative (Ph-) B acute lymphoblastic leukemia (B-ALL). Chemotherapy drugs, such as those in EPOCH+/-R, 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. Tafasitamab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Adding tafasitamab to the DA-EPOCH+/-R regimen may work better than DA-EPOCH+/-R alone in treating newly diagnosed Ph- B-ALL.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that no prior systemic therapy for ALL is allowed except to control acute symptoms, so it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drugs used in the Chemotherapy + Targeted Therapy for Acute Lymphoblastic Leukemia trial?
Research shows that a combination of drugs including prednisone, vincristine, and etoposide (VP-16) can lead to complete remission in some children with relapsed acute lymphoblastic leukemia (ALL). Additionally, a study found that a regimen including vincristine, doxorubicin, and prednisone achieved a high complete remission rate in adults with ALL.12345
Is the combination of chemotherapy and targeted therapy for acute lymphoblastic leukemia generally safe in humans?
The research indicates that certain chemotherapy drugs like idarubicin and liposomal daunorubicin, when used in combination with other treatments, have shown low non-hematologic toxicity (side effects not related to blood) in patients with acute lymphoblastic leukemia. This suggests that these treatments can be generally safe for humans, although individual responses may vary.678910
What makes the chemotherapy and targeted therapy treatment for acute lymphoblastic leukemia unique?
This treatment combines multiple drugs, including cyclophosphamide, doxorubicin, etoposide, prednisone, and vincristine, which are used together to target leukemia cells in different ways. The combination aims to improve outcomes by using drugs with different mechanisms of action, potentially overcoming resistance seen with other treatments.1231112
Eligibility Criteria
This trial is for adults over 18 with newly-diagnosed Ph- B-ALL who can't use pediatric treatments, often due to age or other concerns. Participants need functioning kidneys and liver (with specific limits on enzyme levels), no severe blood count issues for subsequent treatment cycles, a performance status indicating they're not too sick to participate, and an expected survival beyond 3 months.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DA-EPOCH+/-R chemotherapy and tafasitamab for up to 8 cycles, with each cycle lasting 21 days
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Cyclophosphamide (Alkylating agents)
- Doxorubicin (Anti-tumor antibiotic)
- Etoposide (Topoisomerase I inhibitors)
- Prednisone (Corticosteroid)
- Tafasitamab (Monoclonal Antibodies)
- Vincristine (Vinca alkaloids)
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