FORMA 2102-HEM-101: Phase 1/2 Study of FT-2102 for AML or MDS with IDH1 - Clinical Trial
What is the Purpose of this Study?
We are doing this study to test the study drug, FT-2101 (when given alone or in combination with Azacitadine and/or Cytarabine) to treat acute myeloid leukemia and myelodysplastic syndrome.
Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Who Can Participate in the Study?
- Have Acute Myeloid Leukemia or high risk Myelodysplastic Syndrome
- Have documented IDH1-R132 gene mutated disease
- Have not had a prior solid organ transplant
- Do not have other cancers unless you have been disease free for at least 12 months
- Do not have any central nervous system metastases or other tumor locations
- Have not had radiation therapy or major surgery within one month prior to study entry
- Do not have any active infections
- Do not have an uncontrolled disease-related metabolic disorder
What is Involved?
If you choose to join this study, you will:
- Have a screening visit to make sure it is safe for you to be in this study
- Take the study drug, FT-2101, by mouth daily for 28 days
-- Some patients will also be given Azacitadine under the skin or by infusion once daily for 7 days every 28 days
-- Some patients will also get Cytarabine, twice a day injection for 10 days every 28 days
- Have follow up visits that include physical exams and other tests, every 3 months for up to 36 months