Randomized Phase 2 Study of daunorubicin and cytarabine liposome + Pomalidomide versus daunorubicin and cytarabine liposome in Newly Diagnosed AML with MDS-Related Changes

UVA Tracking #
HSR230512
Principal Investigator
Daniel R Reed
Contact
Contact Phone
Official Trial Title
Randomized Phase 2 Study of daunorubicin and cytarabine liposome + Pomalidomide versus daunorubicin and cytarabine liposome in Newly Diagnosed AML with MDS-Related Changes
Study Description

The University of Virginia is participating in a clinical research study for adults ages 18 and over, who have acute myeloid leukemia with myelodysplastic syndrome-related changes or acute myeloid leukemia after previous chemotherapy or radiation treatment. This study is being done to answer the following questions:
• Can we lower the chances of your acute myeloid leukemia (AML) growing by adding pomalidomide, to daunorubicin and cytarabine liposome therapy which is one of the standard treatment most people get for AML?
• What is the safe, tolerable, and effective schedule of pomalidomide treatment when it is given in combination with daunorubicin and cytarabine liposome, to manage your AML?
If you take part in this study you will be enrolled into one of the following two groups:

Group 1: Daunorubicin and cytarabine liposome for induction alone, OR
Group 2: Daunorubicin and cytarabine liposome for induction followed by pomalidomide for 14 days. Pomalidomide treatment will start twenty-one days after completing induction therapy.
After you finish all study related treatments, the study doctor will continue to follow your condition for 5 years from when you started induction therapy.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT04802161

uvacancertrials@hscmail.mcc.virginia.edu

Compensation

No Compensation