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Clinical Trial VICCHEM1096


A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients with Newly Diagnosed Acute Myeloid Leukemia

Principal Investigator(s)

Stephen Strickland


  • Protocol No. VICCHEM1096
  • Open Date: 10/24/2011
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: The primary objective is to compare the overall survival between Arm A and Arm C and between Arm B and Arm C.
  • Disease Sites: Leukemia
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Decitabine; Sapacitabine
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01303796
  • Secondary Protocol No: CYC682-12


Patients are asked to take part in this research study because they are at least 70 years of age and have acute myeloid leukemia (AML). Also, either the patient's doctor does not recommend the use of standard intensive treatment for the AML or they have decided not to receive standard intensive treatment after being fully informed about its benefits and risks by their doctor. This Phase III study tests an investigational anti-cancer drug called sapacitabine and a marketed anti-cancer drug called decitabine. An investigational drug means it has not been approved by the U.S. Food and Drug Administration (FDA) or other regulatory agencies for marketing and is still under study to see how safe it is, what its side-effects are, and whether or not it is effective in the treatment of cancer. Sapacitabine has been given to about 400 cancer subjects in clinical studies. Decitabine and azacitidine have been approved by the FDA for the treatment of a bone marrow disease called myelodysplastic syndromes (MDS) but has not been approved for the treatment of AML. Ara-C has been approved by the FDA for the treatment of AML. The purpose of the first part of this study is to see how safe and well tolerated sapacitabine is when given in alternating cycles with decitabine. The purpose of the second part of this study is to see which of several drug options, is more likely to keep the patient's cancer in check as long as possible. Patients may continue to take part in this study until their disease gets worse or the study closes. If patients are getting benefit at the time the study closes, they may be able to continue getting the study drugs under a special study plan.


Ages Eligible for Study:70 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No


Inclusion Criteria:
• Newly diagnosed AML based on WHO classification
• Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator
• ECOG performance status 0-2
• Adequate renal function
• Adequate liver function
• Able to swallow capsules
• Agree to practice effective contraception
• Ability to understand and willingness to sign the informed consent form
Exclusion Criteria:
• AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
• Having received any systemic anti-cancer therapy for AML or received treatment with hypomethylating agents or cytotoxic chemotherapy for the preceding MDS or MPD
• Known or suspected central nervous system (CNS) involvement by leukemia
• Uncontrolled intercurrent illness
• Known hypersensitivity to decitabine
• Known to be HIV-positive