Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients
Trial ID or NCT#
NCT00590187
Status
NOT RECRUITING
Purpose
The objective is to treat elderly AML and MDS patients with sapacitabine.
Official Title
A Randomized Phase 2 Study of Oral Sapacitabine in Elderly Patients With Acute Myeloid Leukemia Previously Untreated or in First Relapse, or Previously Treated Myelodysplastic Syndromes
Eligibility Criteria
Ages Eligible for Study: Older than 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
- * A histologically or pathologically confirmed diagnosis of AML based on WHO classification which is previously untreated by systemic therapy or is in first relapse after achieving a complete remission to initial induction, consolidation and/or maintenance therapy or MDS with IPSS scores of intermediate -2 or higher risk risk which has been previously treated with hypomethylating agents* Age 70 years or older for AML and 60 years or older for MDS* Eastern Cooperative Oncology Group (ECOG) performance status 0-2* Adequate renal function defined as serum creatinine equal to or less than 1.5 x upper limit of normal (ULN)* Adequate liver function defined as total bilirubin or direct bilirubin equal to or less than 1.5 x ULN; alanine aminotransferase (ALT or SGPT) equal to or less than 2.5 x ULN (5 x ULN if tumor has affected the liver)* Life expectancy reasonably adequate for evaluating the treatment effect* Patient must be able to swallow capsules* Patients must be at least 2 weeks from prior systemic therapy, radiation therapy, major surgery, or other investigational therapy, and have recovered from clinically significant toxicities of these prior treatments* All men and women of reproductive potential must agree to practice effective contraception for 4 weeks prior to study entry, during the entire study period and for one month after the study unless documentation of infertility exists* Ability to understand and willingness to sign the informed consent form
Exclusion Criteria:
- * AML is of the sub-type of acute promyelocytic leukemia* Having received more than one induction systemic therapy for AML or having received a standard dose or high dose ara-C containing regimen for MDS* Patients with known central nervous system (CNS) involvement by leukemia* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active cancer(s) other than AML, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patients receiving intravenous antibiotics for infections that are under control may be included in this study* Known to be HIV-positive
Investigator(s)
Steven Coutre
Contact us to find out if this trial is right for you.
Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov
