Chemotherapy + Ponatinib for Acute Lymphoblastic Leukemia
Trial Summary
What is the purpose of this trial?
This phase II trial studies the side effects and how well combination chemotherapy and ponatinib hydrochloride work in treating patients with acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone, 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. Ponatinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy and ponatinib hydrochloride may be an effective treatment for acute lymphoblastic leukemia.
Will I have to stop taking my current medications?
The trial requires that you stop taking any medications or herbal supplements that are strong inhibitors of CYP3A4 at least 14 days before starting ponatinib. If you are taking drugs that may cause a heart rhythm problem called torsades de pointes, you may need to switch to alternatives.
What data supports the effectiveness of the drug combination used in the Chemotherapy + Ponatinib for Acute Lymphoblastic Leukemia trial?
Research shows that combinations of drugs like vincristine, prednisone, and doxorubicin can induce remission in patients with relapsed acute lymphoblastic leukemia (ALL). Additionally, methotrexate and mercaptopurine have been used effectively in post-remission treatment to help prevent relapse in high-risk ALL patients.12345
Is the combination of chemotherapy drugs, including vincristine, generally safe for treating acute lymphoblastic leukemia?
The combination of chemotherapy drugs, including vincristine, has been studied in various regimens for treating acute lymphoblastic leukemia (ALL). Some studies have shown that these combinations can be effective, but they may also lead to side effects like infections and other non-blood-related issues. It's important to discuss potential risks and benefits with your healthcare provider.26789
What makes the chemotherapy and ponatinib treatment unique for acute lymphoblastic leukemia?
This treatment combines chemotherapy with ponatinib, a third-generation tyrosine kinase inhibitor, which has shown promising results in improving survival rates for patients with Philadelphia chromosome-positive acute lymphoblastic leukemia, especially when compared to earlier treatments like imatinib. Ponatinib is particularly effective in achieving complete molecular responses, making it a novel option for this condition.1011121314
Research Team
Elias Jabbour, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for patients with untreated or previously treated Ph-positive acute lymphoblastic leukemia (ALL) or chronic myelogenous leukemia (CML) in blast phase. Participants must be physically able to perform daily activities with minimal assistance, have normal organ function, and agree to use effective contraception. Excluded are those with serious infections, active hepatitis B, severe heart conditions, uncontrolled blood pressure, a history of significant bleeding disorders unrelated to cancer, or alcohol abuse.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive combination chemotherapy and ponatinib hydrochloride in cycles. Odd cycles include cyclophosphamide, doxorubicin, vincristine, dexamethasone, and ponatinib. Even cycles include methotrexate, ponatinib, and cytarabine. Treatment repeats every 3-4 weeks for up to 8 cycles.
Maintenance Therapy
Participants receive vincristine, prednisone, and ponatinib. Cycles repeat every 28 days for 24 months.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs at 30 days and then every 6 months for up to 24 months.
Treatment Details
Interventions
- Cyclophosphamide
- Doxorubicin Hydrochloride
- Methotrexate
- Ponatinib Hydrochloride
- Prednisone
- 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?
M.D. Anderson Cancer Center
Lead Sponsor