NCT01303796

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 482 (actual)
• Sponsor: Cyclacel Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, randomized, Phase 3 study ("SEAMLESS") comparing two 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, 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 Arm A versus Arm C.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Sapacitabine	Oral sapacitabine capsules
DRUG	Decitabine	Decitabine intravenous

Timeline

• Start date: 2011-10-01
• Primary completion: 2016-12-15
• Completion: 2017-07-31
• First posted: 2011-02-25
• Last updated: 2022-06-22
• Results posted: 2022-06-22

Locations

118 sites across 12 countries: United States, Austria, Belgium, France, Germany, Hungary, Italy, Poland, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study