Overview

This trial is active, not recruiting.

Condition acute myeloid leukemia
Treatments sapacitabine and decitabine, decitabine
Phase phase 3
Sponsor Cyclacel Pharmaceuticals, Inc.
Start date January 2011
End date October 2015
Trial size 485 participants
Trial identifier NCT01303796, CYC682-12

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Sapacitabine and decitabine
sapacitabine and decitabine
Sapacitabine administered in alternating cycles with decitabine
(Active Comparator)
Decitabine
decitabine
Decitabine alone

Primary Outcomes

Measure
Overall survival
time frame: up to 43 months

Secondary Outcomes

Measure
Complete remission with duration
time frame: Up to 43 months
Complete remission with incomplete platelet count recovery and duration
time frame: up to 43 months
Partial remission with duration
time frame: up to 43 months
Hematological improvement with duration
time frame: up to 43 months
Stable disease with duration
time frame: up to 43 months
Number of units of blood product transfused
time frame: up to 43 months
Hospitalized days
time frame: up to 43 months
1-year survival
time frame: up to 43 months

Eligibility Criteria

Male or female participants at least 70 years old.

Inclusion Criteria: - Newly diagnosed AML based on WHO 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 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 the preceding MDS or MPD - Known or suspected central nervous system (CNS) involvement by leukemia - Uncontrolled intercurrent illness - Known hypersensitivity to decitabine - Known to be HIV-positive

Additional Information

Official title A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Description This is a multicenter, randomized, Phase 3 study 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Cyclacel Pharmaceuticals, Inc..