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E2902--Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission of in Remission after Primary Induction Failure or Patients over Age 60 in First Remission

The purpose of this study is to compare the use of an investigational drug, R115777, a farnesyl transferase inhibitor, as maintenance therapy, to observation only with respect to disease-free survival in patients with AML in second or subsequent complete remission or in complete remission following primary induction failure.


Eligibility

You may be eligible for this trial if:

  • You are in one of the following categories:
    • You are in first remission following primary induction failure; you must have received at least two chemotherapy induction regimens.
    • You are in second or subsequent remission.
    • You are over 60 years old in first remission.
  • You are in complete remission or molecular remission by blood counts and bone marrow studies. Confirmatory bone marrow must be performed < 2 weeks prior to randomization.
  • Acute Promyelocytic leukemia is not eligible
  • You must be registered for the study within 60 days of completing therapy

Trial Sponsor

  • Eastern Cooperative Oncology Group (ECOG)

Project Begin Date

  • Mar 2006

Tentative Project End Date

  • Mar 2010

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Revised March 30, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .