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

Completed · Phase 3

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT01303796

Run by

Cyclacel Pharmaceuticals, Inc.

People needed

482

Starts

2011-10-01

Expected to finish

2017-07-31

Last updated by the study team

2022-06-22

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scripps Cancer Center — La Jolla, California, United States
• UCLA Ronald Reagan Medical Center — Los Angeles, California, United States
• Norwalk Hospital — Norwalk, Connecticut, United States
• Shands Cancer Hospital at University of Florida — Gainesville, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• Blood and Marrow Transplant Group of Georgia — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• St. Francis Medical Group Oncology and Hematology Specialists — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Maryland Greenbaum Cancer Center — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Saint Luke's Cancer Institute — Kansas City, Missouri, United States
• St. Louis University Cancer Center — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Dartmouth - Hitchcock Medical Center — Lebanon, New Hampshire, United States
• John Theurer Cancer Center at the Hackensack University Medical Center — Hackensack, New Jersey, United States
• Westchester Hematology Oncology Group, PC — Hawthorne, New York, United States
• Beth Israel Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Alabama Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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