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

Phase 3
70 Years
Open (Enrolling)
Acute Myeloid Leukemia

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Trial Information

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

This is a multicenter, randomized, Phase 3 study comparing two drug regimens (arms) as the
front-line treatment of elderly patients aged 70 years or older with newly diagnosed acute
myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy. In Arm
A, sapacitabine is administered in alternating cycles with decitabine, and in Arm C
decitabine is administered alone. The primary efficacy endpoint is overall survival. The
study is designed to demonstrate an improvement in overall survival of Arm A versus Arm C.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

up to 43 months

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2011

Completion Date:

April 2015

Related Keywords:

  • Acute Myeloid Leukemia
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



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Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
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Scripps Cancer Center La Jolla, California  92037
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Blood and Marrow Transplant Group of Georgia Atlanta, Georgia  30342-1601
Henry Ford Health System Detroit, Michigan  48202
University of Maryland Greenbaum Cancer Center Baltimore, Maryland  21201
Norwalk Hospital Norwalk, Connecticut  06856
Saint Luke's Cancer Institute Kansas City, Missouri  64111
Winship Cancer Institute, Emory University Atlanta, Georgia  30322
Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Stony Brook University Medical Center Stony Brook, New York  11794
Cancer Center of Central Connecticut Southington, Connecticut  
Huntsman Cancer Institute at the University of Utah Salt Lake City, Utah  84112
St. Louis University Cancer Center St. Louis, Missouri  63110
Cleveland Clinic Florida Weston, Florida  33331
Gabrail Cancer Center Research Canton, Ohio  44718
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The Medical College of Wisconsin Milwaukee, Wisconsin  53226