Pomalidomide + Chemotherapy for Acute Myeloid Leukemia
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that anti-cancer therapy should be stopped more than 72 hours before starting the trial treatment, and the use of strong CYP1A2 inhibitors should be avoided. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Pomalidomide + Chemotherapy for Acute Myeloid Leukemia?
The drug CPX-351, which is part of the treatment, has shown improved outcomes in patients with acute myeloid leukemia (AML) compared to traditional chemotherapy. It has been effective in prolonging survival and achieving higher remission rates in clinical trials, particularly in older patients with high-risk AML.12345
Is the combination of Pomalidomide and CPX-351 safe for humans?
CPX-351, also known as Vyxeos, is a combination of two drugs, daunorubicin and cytarabine, used to treat certain types of acute myeloid leukemia (AML). It has been shown to have a safety profile similar to traditional chemotherapy, with some differences like more prolonged low blood cell counts. However, there is no specific safety data available for the combination of Pomalidomide with CPX-351.34678
What makes the drug Pomalidomide + Chemotherapy unique for treating Acute Myeloid Leukemia?
This drug combines Pomalidomide with a liposome-encapsulated formulation of daunorubicin and cytarabine, which maintains a specific 5:1 molar ratio to enhance effectiveness. The liposome delivery system helps protect the drugs from being broken down too quickly, allowing them to target leukemia cells more effectively and potentially reducing side effects compared to traditional chemotherapy.12346
What is the purpose of this trial?
This trial is testing if adding pomalidomide to standard chemotherapy can improve treatment for patients with a specific type of newly diagnosed leukemia. Pomalidomide works by cutting off the blood supply to cancer, boosting the immune system, and killing cancer cells. The chemotherapy drugs attack cancer cells in multiple ways. Pomalidomide is related to thalidomide and has shown remarkable activity in patients who did not respond to other treatments.
Research Team
Joshua F Zeidner
Principal Investigator
Ohio State University Comprehensive Cancer Center LAO
Eligibility Criteria
Adults aged 18-75 with newly diagnosed acute myeloid leukemia (AML) and specific genetic mutations or changes related to myelodysplastic syndrome, who have good organ function and performance status. They must not have had previous AML treatment except hydroxyurea or leukapheresis, no Wilson's Disease, uncontrolled illnesses, prior allogeneic stem cell transplant, or certain cumulative doses of daunorubicin. Women of childbearing potential must test negative for pregnancy and use two forms of birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction
Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5. In Arm A, pomalidomide is added orally once daily for 14 days starting between days 21-30.
Consolidation
Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up for 30 days, then up to 5 years.
Treatment Details
Interventions
- Liposome-encapsulated Daunorubicin-Cytarabine
- Pomalidomide
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?
National Cancer Institute (NCI)
Lead Sponsor