CPX-351 + Quizartinib for Acute Myeloid Leukemia
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot take certain drugs that affect heart rhythm or strong CYP3A4 inducers. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug CPX-351 + Quizartinib for Acute Myeloid Leukemia?
Is CPX-351 safe for humans?
What makes the drug CPX-351 + Quizartinib unique for treating acute myeloid leukemia?
CPX-351 is unique because it combines two chemotherapy drugs, daunorubicin and cytarabine, in a special liposome (a tiny bubble-like structure) that helps deliver the drugs more effectively to cancer cells. This combination has shown improved survival rates compared to the traditional 7+3 chemotherapy regimen, especially in older adults with high-risk acute myeloid leukemia.568910
What is the purpose of this trial?
This phase I/II trial studies the side effects and best dose of CPX-351 in combination with quizartinib for the treatment of acute myeloid leukemia and high risk myelodysplastic syndrome. CPX-351, composed of chemotherapy drugs daunorubicin and cytarabine, works 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. Quizartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The goal of this study is to learn if the combination of CPX-351 and quizartinib can help to control acute myeloid leukemia and myelodysplastic syndrome.
Research Team
Musa Yilmaz
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS), who have either not received chemotherapy or have had up to four prior treatments. Participants must be over 60 years old for the frontline cohort, and at least 18 for the relapsed/refractory cohort. They should have adequate organ function, no severe concurrent illnesses, and women of childbearing potential must use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction
Patients receive CPX-351 IV on days 1, 3, and 5 and quizartinib PO on days 6-19. Treatment repeats every 28 days for up to 2 cycles.
Consolidation
Patients receive CPX-351 IV on days 1 and 3 and quizartinib PO on days 4-28. Treatment repeats every 28 days for 2 cycles.
Maintenance
Patients receive quizartinib PO on days 1-28 in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
Treatment Details
Interventions
- Liposome-encapsulated Daunorubicin-Cytarabine
- Quizartinib
Liposome-encapsulated Daunorubicin-Cytarabine is already approved in United States for the following indications:
- Acute Myeloid Leukemia with myelodysplasia-related changes (AML-MRC)
- Therapy-related AML (t-AML)
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator