ALX148 in combo with Aza in patients with higher risk MDS (Myelodysplastic Syndrome)
What is the Purpose of this Study?
- Have a physical exam
- Have a heart scan (ECG)
- Have blood draws
After the screening period, this study is divided into 2 phases. During Phase 1, increasing doses of the study drug will be given in combination with AZA. During Phase 2, the study drug will be given at a dose selected from Phase 1, either on its own or in combination with AZA. Whether you participate in Phase 1 or 2 depends on when you join the study.
In either phase of the study, you will:
- Receive the study drug as an infusion (IV) every 2 or 4 weeks
- Receive AZA as an infusion for 7 straight days every 4 weeks (unless you are in Phase 2 and selected to receive the study drug on its own)
Your study drug schedule may change depending on how well you tolerate the drug.
You may participate in the study for as long as you have a positive benefit from the study drug, do not experience severe side effects, and are able to come to the clinic for study visits.
Who Can Participate in this Study?
- Are diagnosed with relapsed or refractory MDS; OR
- Are diagnosed with Higher Risk MDS and have not received hypomethylating agents or cytotoxic chemotherapy; OR
- Are diagnosed with Higher Risk MDS that has not been treated yet
- Have bone marrow with less than 20% myeloblasts
- Have not received an allogeneic (from a donor) stem cell transplant for cancer treatment
For more information about who can join this study, please contact the study team at 919-660-2077.
What is Involved?
We are doing this study to find the most effective, safe dose of an experimental drug called ALX148. We want to know how well this study drug works in people with MDS when it is given in combination with azacytidine (AZA).