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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.

What is the Condition Being Studied?

Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Who Can Participate in the Study?

Adults who:
- 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

Age Group
Adults

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

Study Details

Full Title
A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination with Azacitidine or Cytarabine in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome with an IDH1 Mutation
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB:PRO00084708
NCT:NCT02719574
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698