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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
N/A
Open (Enrolling)
Both
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
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

Type of Study:

Interventional

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:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

CYC682-12

NCT ID:

NCT01303796

Start Date:

January 2011

Completion Date:

April 2015

Related Keywords:

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

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021
MD Anderson Cancer Center Houston, Texas  77030-4096
Cleveland Clinic Foundation Cleveland, Ohio  44195
Mayo Clinic Rochester, Minnesota  55905
University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Northwestern Memorial Hospital Chicago, Illinois  60611
Beth Israel Medical Center New York, New York  10003
Joe Arrington Cancer Research and Treatment Center Lubbock, Texas  79410-1894
Rush University Medical Center Chicago, Illinois  60612-3824
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Baylor University Medical Center Dallas, Texas  75246
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Duke University Medical Center Durham, North Carolina  27710
Scripps Cancer Center La Jolla, California  92037
The University of Chicago Medical Center Chicago, Illinois  60637-1470
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
Georgia Health Sciences University Augusta, Georgia  30912
UCLA Ronald Reagan Medical Center Los Angeles, California  90095
St. Francis Medical Group Oncology and Hematology Specialits Indianapolis, Indiana  46237
Dartmouth - Hitchcock Medical Center Lebanon, New Hampshire  03756
John Theurer Cancer Center at the Hackensack University Medical Center Hackensack, New Jersey  07601
Westchester Hematology Oncology Group, PC Hawthorne, New York  10532
The Medical College of Wisconsin Milwaukee, Wisconsin  53226