Forma: Ph 1/2 FT-2102 with aza or cytarabine in AML or MDS with IDH1 (2102-HEM-101)

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 this 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
Participating Institutions

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

Contacts
Protocol Number
IRB:
PRO00084708

NCT:
NCT02719574
ClinicalTrials.gov
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