A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2017-07-31
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cyclacel Pharmaceuticals, Inc.
• Treatments: Azacitidine; Decitabine; Sapacitabine

Criteria

Inclusion Criteria:

• Newly diagnosed AML based on WHO (World Health Organization) classification

• 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

• ECOG (Eastern Cooperative Oncology Group) performance status 0-2

• Adequate renal function

• Adequate liver function

• Able to swallow capsules

• Agree to practice effective contraception

• 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

• Having received any systemic anti-cancer therapy for AML or received treatment with hypomethylating agents or cytotoxic chemotherapy for preceding myelodysplastic syndrome (MDS) or myeloproliferative disease (MPD)

• Known or suspected central nervous system (CNS) involvement by leukemia

• Uncontrolled intercurrent illness

• Known hypersensitivity to decitabine

• Known to be HIV-positive