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Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients
Not Recruiting
Trial ID: NCT00590187
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
Stanford Investigator(s)
Caroline Berube
Clinical Associate Professor, Medicine - Hematology
Jason Gotlib
Professor of Medicine (Hematology)
Eligibility
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
Intervention(s):
drug: Sapacitabine, Arm A
drug: Sapacitabine, Arm B
drug: Sapacitabine, Arm C
drug: Sapacitabine, Arm D
drug: sapacitabine, Arm E
drug: sapacitabine, Arm F
drug: Sapacitabine, Arm G
drug: Sapacitabine, Arm H
drug: Sapacitabine, Arm I
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061