Liposomal Daunorubicin-Cytarabine + Venetoclax for Acute Myeloid Leukemia
Trial Summary
What is the purpose of this trial?
This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine and venetoclax work in treating participants with acute myeloid leukemia that has come back (relapsed), does not respond to treatment (refractory), or has not been treated (untreated). Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine and venetoclax, 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, prior therapy with certain drugs like hydroxyurea, hematopoietic growth factors, or tretinoin is allowed without a break, and a specific dose of ara-C is allowed if given more than 48 hours before joining the trial.
What data supports the effectiveness of the drug Liposomal Daunorubicin-Cytarabine (CPX-351) for treating Acute Myeloid Leukemia?
Is the treatment Liposomal Daunorubicin-Cytarabine + Venetoclax safe for humans?
The treatment using Liposomal Daunorubicin-Cytarabine, also known as CPX-351 or Vyxeos, has been shown to have an acceptable safety profile in older adults with certain types of acute myeloid leukemia, with side effects similar to traditional chemotherapy. It is approved for use in several countries and has been studied in clinical trials, indicating it is generally safe for human use in the conditions tested.12346
What makes the drug Liposomal Daunorubicin-Cytarabine + Venetoclax unique for treating acute myeloid leukemia?
This drug is unique because it uses a liposomal formulation to deliver a fixed, synergistic ratio of daunorubicin and cytarabine, which enhances its effectiveness and prolongs survival compared to traditional chemotherapy. The liposome helps protect the drugs from being broken down too quickly, allowing for better targeting of leukemia cells and potentially reducing side effects.23457
Eligibility Criteria
Adults diagnosed with Acute Myeloid Leukemia that's untreated, not responding to treatment, or has returned after treatment. Participants must be over 18 (up to 69 for certain groups), have acceptable organ function and performance status, and women of childbearing age must test negative for pregnancy. Those with CNS leukemia, prior CPX-351 or venetoclax use (except specific cases), uncontrolled illnesses, known hypersensitivity to the drugs used, or unwillingness to use contraception are excluded.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive liposome-encapsulated daunorubicin-cytarabine IV and venetoclax PO. Treatment repeats every 28 days for up to 2 cycles.
Consolidation
Participants receive liposome-encapsulated daunorubicin-cytarabine IV and venetoclax PO. Treatment repeats every 28 days for up to 4 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Liposome-encapsulated Daunorubicin-Cytarabine (Anti-tumor antibiotic, Anti-metabolites)
- Venetoclax (B-cell lymphoma-2 (BCL-2) inhibitor)
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)