Please note: This trial has finished recruiting and is not accepting new participants.

Research Center: University of Minnesota
Location: Minneapolis, MN 55455, United States
Lead Doctor: Erica D. Warlick, MD
Study Sponsor: GT BioPharma
IRB Committee: This study has been reviewed and approved by University of Minnesota Institutional Review Board

Background

Researchers present a potential new treatment for those who have myelodysplastic syndrome (MDS), relapsed acute myelogenous leukemia (AML) or advanced systemic mastocytosis. MDS and AML are blood and bone marrow cancers. In 2004, 70 out of 100,000 US adults were diagnosed with (MDS). An estimate of 3-5% out of 100,000 adults have AML. Systemic mastocytosis can become cancerous and happens when a group of mast cells clumps together in an organ system.

This study wants to understand the safety and effectiveness of the potential anti-cancer properties found in a new investigational treatment. This new potential treatment activates Natural Killer (NK) cells. These cells are white blood cells that kill cancer cells. This is a “first-in-human” study which means that this is the first time this treatment is being tested on humans.

Interested participants must be 18 to 75 years of age and have either myelodysplastic syndrome (MDS), relapsed acute myelogenous leukemia (AML) or advanced systemic mastocytosis. The study will last about 3 months which includes a one month screening period, a 3 week treatment period (which includes 3 weekly Monday to Friday hospital confinements depending on the study group you are in) and an end of treatment visit.

Why Participate? 

• You may experience a benefit from the investigational treatment, however this is not guaranteed .
• You will receive the investigational cancer treatment at no cost. 
• You will help develop a potential treatment for cancer patients in the future.
• You will be helping to advance medical research.

Your Rights

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.
• Your records relating to this study and any other information received will be kept strictly confidential, except as required by the law.
• Qualified health professionals will monitor your health as it relates to the study.

Who Can Participate?

• Adults aged 18 to 75 years old who have either myelodysplastic syndrome (MDS), relapsed acute myelogenous leukemia (AML) or advanced systemic mastocytosis.
• Must agree to several 4 day inpatient hospitalizations.
• Able to attend multiple study visits at the research site over approximately 3 months.