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

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cyclacel Pharmaceuticals, Inc.
• Collaborator: M.D. Anderson Cancer Center
• Treatments: Azacitidine; Decitabine; Sapacitabine; Venetoclax

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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