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

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase III
Eligibility
70 and over, Male and Female
Study Type
Treatment
NCD ID
NCT01303796
Protocol IDs
CYC682-12 (primary)
Study Sponsor
Cyclacel Pharmaceuticals, Incorporated

Summary

This Phase 3 study assesses three 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 three drug regimens are sapacitabine administered in alternating cycles with decitabine, sapacitabine alone 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.

Objectives

This is a multicenter, randomized, Phase 3 study comparing three drug regimens (arms) as the front-line treatment of elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy. In Arm A, sapacitabine is administered in alternating cycles with decitabine, in Arm B sapacitabine is administered alone and in Arm C decitabine is administered alone. The primary efficacy endpoint is overall survival. The study is designed to demonstrate an improvement in overall survival of either of two pairwise comparisons: (1) Arm A versus Arm C or (2) Arm B versus Arm C.

Treatment Sites in Georgia


Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

Study Coordinator:
Beverly Bryan
404-778-4994

Doctors:

Martha L. Arellano MD
Leonard T. Heffner Jr., MD
H. Jean Khoury MD, FACP
Amelia A. Langston MD
Elliott F. Winton MD