ALX148 in combo with Aza in patients with higher risk MDS (Myelodysplastic Syndrome)
What is the Purpose of this Study?
If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:
- 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.
- 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.
What is the Condition Being Studied?
Higher Risk Myelodysplastic Syndrome (MDS)
Who Can Participate in this Study?
Adults who:
- 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.
Age Group
Adults
Participating Institutions
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).
Study Details
Full Title
A PHASE 1/2 STUDY OF ALX148 IN COMBINATION WITH AZACITIDINE IN PATIENTS WITH HIGHER RISK MYELODYSPLASTIC SYNDROME (MDS)
Principal Investigator
Protocol Number
IRB:
PRO00106302
NCT:
NCT04417517
ClinicalTrials.gov
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