Study of Sapacitabine in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia, Myelodysplastic Syndromes

In brief

This is a combination study to evaluate sapacitabine administered in alternating cycles with decitabine in previously untreated Acute Myeloid Leukemia (AML) or concomitantly with venetoclax in previously treated AML or MDS

Key facts

Study ID

NCT01211457

Run by

Cyclacel Pharmaceuticals, Inc.

People needed

65

Starts

2010-06-17

Expected to finish

2020-12-31

Last updated by the study team

2019-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed AML based on WHO classification (Part 1) or previously treated AML or MDS (Part 2)
• Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator (Part 1); age 18 years or older (Part 2)
• ECOG performance status 0-2
• Adequate renal function
• Adequate liver function
• Able to swallow capsules
• Ability to understand and willingness to sign the informed consent form

You may not qualify if…

• AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
• Known central nervous system (CNS) involvement by leukemia
• Uncontrolled intercurrent illness including
• Known hypersensitivity to decitabine (Part 1) or venetoclax (Part 2)
• Known to be HIV-positive

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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