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This study is being done to identify if there is a safe, tolerable, and effective schedule of pomalidomide treatment when it is given in combination after induction therapy with daunorubicin and cytarabine liposome for acute myeloid leukemia (AML). Additionally, the study will evaluate if the combination of pomalidomide and daunorubicin and cytarabine liposome induction therapy is more effective in controlling AML than induction therapy with daunorubicin and cytarabine liposome alone.
This study will help the study doctors find out if this different approach is better, the same or worse than the usual approach. The usual approach is with the drugs daunorubicin and cytarabine liposome and is given at the beginning of therapy, called induction. These drugs are approved by the U.S. Food and Drug Administration (FDA) for the treatment of AML.
Pomalidomide is an immunomodulating agent that stimulates or suppresses the immune system and may help the body fight cancer, infection, or other diseases. Pomalidomide is approved by the FDA for use in multiple myeloma, but it has not been approved for AML. The FDA has also not approved pomalidomide use in combination with daunorubicin and cytarabine liposome for treating AML.
This study has two parts. Prior to study enrollment, all participants will undergo induction therapy with daunorubicin and cytarabine liposome.
The first part will investigate the safety and effectiveness of receiving pomalidomide after daunorubicin and cytarabine liposome induction therapy. Participants in part 1 of the study will be put into one of two groups. Group A will take pomalidomide orally for 14 days and Group B will take pomalidomide for 21 days.
The second part of this study will compare between the effectiveness of receiving induction therapy in combination with pomalidomide, versus receiving induction therapy only. Participants will be randomized into one of two study groups. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group. Group 1 will receive daunorubicin and cytarabine liposome only through a vein in the arm. Group 2 will receive daunorubicin and cytarabine liposome plus pomalidomide.
The study team will discuss dosing and length of participation with each individual depending on which part of the study and study group they are in.
Detailed eligibility will be discussed when reaching out to the study team.