Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia

Not Recruiting

Trial ID: NCT00512083


The overall aim of this study is to assess the efficacy and safety of AS1411, over a range of doses, when combined with cytarabine, in the treatment of patients with primary refractory or relapsed acute myeloid leukemia (AML).

Official Title

An Open Label Randomized Controlled Dose Escalating Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia


Inclusion Criteria:

   - primary refractory or relapsed AML

   - confirmed diagnosis of AML (de novo or secondary) as defined by WHO classification
   (Vardiman 2002)

   - aged at least 18 years

Exclusion Criteria:

   - initial diagnosis of acute promyelocytic leukemia as defined by
   French-American-British criteria (Bennett 1976)

   - patient in blast crisis stage of chronic myeloid leukemia

   - received high-dose cytarabine (total cumulative dose of >6g/m sq)in last 6 months

   - interval of <6 months between first onset of last complete remission and current

   - those with primary refractory leukemia who have received more than three previous
   induction cycles

   - relapsed patients who have received more than three previous treatment regimens


drug: AS1411

Not Recruiting

Contact Information

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

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