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

The main objective of this study is to learn which sapacitabine treatment is more likely to keep the cancer in check for at least one year in AML patients who are at least 70 years of age or older and in MDS patients who are at least 60 years of age.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Sapacitabine

Phase: Phase 2

Eligibility

Ages Eligible For Study:

60 Years - N/A

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

External Links

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Contact information

Primary Contact:

Michelle Takahashi 6507364032

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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