Overview

This trial is active, not recruiting.

Condition acute myeloid leukemia
Treatment sapacitabine and decitabine
Phase phase 1/phase 2
Sponsor Cyclacel Pharmaceuticals, Inc.
Start date June 2010
End date June 2014
Trial size 40 participants
Trial identifier NCT01211457, CYC682-11

Summary

This is an open label, phase I/II study to evaluate the safety and efficacy of sapacitabine administered in alternating cycles with decitabine in elderly patients with newly diagnosed Acute Myeloid Leukemia (AML).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
decitabine will be administered in alternating cycles with sapacitabine
sapacitabine and decitabine
decitabine will be administered in alternating cycles with sapacitabine

Primary Outcomes

Measure
Number of patients who achieve a clinical benefit response including CR, CRp, PR and major HI
time frame: 2 years

Secondary Outcomes

Measure
response duration
time frame: 2 years
transfusion requirements
time frame: 2 years
hospitalized days
time frame: 2 years
overall survival
time frame: 2 years

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 - 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 central nervous system (CNS) involvement by leukemia - Uncontrolled intercurrent illness including - Known hypersensitivity to decitabine - Known to be HIV-positive

Additional Information

Official title A Phase I/II Combination Study of Sapacitabine in Acute Myeloid Leukemia
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Cyclacel Pharmaceuticals, Inc..