A Randomized Phase II Trial of Decitabine-Based Induction Strategies for Patients >/= 60 Years Old With Acute Myeloid Leukemia (AML)
I. To determine if treatment of older acute myeloid leukemia (AML) patients with decitabine
and bortezomib significantly improves the overall survival times of older AML patients
compared with decitabine alone.
I. To determine the rate of complete remission (CR and CR + CRi) for each of the 2 treatment
regimens in the proposal.
II. To determine the overall survival, progression-free survival, disease-free survival and
for each of the treatment regimens on this study.
III. To determine whether ongoing treatment with these regimens prolongs overall survival
even in the absence of complete remission.
IV. To describe the frequency and severity of adverse events, as well as the tolerability of
each of these regimens in patients treated on this study.
V. To describe the interaction of pretreatment disease and patient characteristics including
morphology, cytogenetics, molecular genetics, WBC count, blood and bone marrow blast count,
age, performance status and comprehensive geriatric assessment on clinical outcomes.
OUTLINE: This is a multicenter study. Patients are stratified according to age (60-69 years
vs >= 70 years). Patients are randomized to 1 of 2 treatment arms.
REMISSION INDUCTION THERAPY: Patients receive decitabine intravenously (IV) over 1 hour once
daily (QD) on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of
disease progression or unacceptable toxicity. Patients achieving complete remission (CR) or
complete remission with incomplete blood count recovery (CRi) proceed to continuation
CONTINUATION THERAPY: Patients receive decitabine IV over 1 hour QD on days 1-5. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
REMISSION INDUCTION THERAPY: Patients receive decitabine IV over 1 hour QD on days 2-11 and
bortezomib subcutaneously (SC) on days 1, 4, 8, and 12. Treatment repeats every 28 days for
2-4 courses in the absence of disease progression or unacceptable toxicity. Patients
achieving CR or CRi proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive bortezomib SC on day 1 and decitabine IV over 1 hour
QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or
After completion of study treatment, patients are followed up every 2 months for 2 years,
every 3 months for 2 years, and then once a year for 6 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival time
Methods of Kaplan and Meier will also be used to evaluate survival distributions between the two treatment arms. Median and year-based survival estimates will be calculated along with corresponding 95% confidence intervals. In addition, use of Cox proportional hazards models to evaluate differences in OS between the treatment arms with stratification on age group as well as adjustment for other potential factors of interest.
Time from study entry to the date of death due to any cause, assessed up to 10 years
Cancer and Leukemia Group B
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|North Shore University Hospital||Manhasset, New York 11030|
|Eastern Maine Medical Center||Bangor, Maine 04401|
|Weill Medical College of Cornell University||New York, New York 10021|
|Long Island Jewish Medical Center||New Hyde Park, New York 11040|
|Mount Sinai Medical Center||New York, New York 10029|
|Munson Medical Center||Traverse City, Michigan 49684|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|
|Beebe Medical Center||Lewes, Delaware 19958|
|Mecosta County Medical Center||Big Rapids, Michigan 49307|
|Mountainview Medical||Berlin, Vermont 05602|
|Harold Alfond Center for Cancer Care||Augusta, Maine 04330|
|Union Hospital of Cecil County||Elkton MD, Maryland 21921|
|Cancer Centers of the Carolinas - Grove Commons||Greenville, South Carolina 29605|
|Cancer Centers of the Carolinas - Seneca||Seneca, South Carolina 29672|
|Cancer Centers of the Carolinas - Spartanburg||Spartanburg, South Carolina 29307|
|Presbyterian Hospital||Charlotte, North Carolina 28233-3549|
|University of North Carolina||Chapel Hill, North Carolina 27599|
|Dartmouth Hitchcock Medical Center||Lebanon, New Hampshire 03756|
|University Of Vermont||Burlington,, Vermont 05403|
|Florida Hospital||Orlando, Florida 32803|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|
|Palo Alto Medical Foundation-Camino Division||Mountain View, California 94040|
|Lombardi Comprehensive Cancer Center at Georgetown University||Washington, District of Columbia 20057|
|Evanston CCOP-NorthShore University HealthSystem||Evanston, Illinois 60201|
|Fort Wayne Medical Oncology and Hematology Inc - State Boulevard||Fort Wayne, Indiana 46845|
|Grand Rapids Clinical Oncology Program||Grand Rapids, Michigan 49503|
|Saint Mary's Health Care||Grand Rapids, Michigan 49503|
|Spectrum Health at Butterworth Campus||Grand Rapids, Michigan 49503|
|Mercy Health Partners-Mercy Campus||Muskegon, Michigan 49443|
|Cooper Hospital University Medical Center||Camden, New Jersey 08103|
|Wayne Memorial Hospital||Goldsboro, North Carolina 27534|
|Margaret R Pardee Memorial Hospital||Hendersonville, North Carolina 28791|
|Kinston Medical Specialists PA||Kinston, North Carolina 28501|
|Greenville CCOP||Greenville, South Carolina 29615|
|Greenville Memorial Hospital||Greenville, South Carolina 29605|
|University of Missouri - Ellis Fischel||Columbia, Missouri 65203|
|East Carolina University||Greenville, North Carolina 27858|
|Cancer Centers of the Carolinas - Faris||Greenville, South Carolina 29605|
|Cancer Centers of the Carolinas-Greer Medical Oncology||Greer, South Carolina 29650|
|Monter Cancer Center||Lake Success, New York 11042|
|Spectrum Health Reed City Hospital||Reed City, Michigan 49677|
|Cancer Care Associates-Mercy||Oklahoma City, Oklahoma 73120|
|Cancer and Leukemia Group B||Chicago, Illinois 60606|
|North Shore-LIJ Health System CCOP||Manhasset, New York 11030|
|Christiana Care Health System-Christiana Hospital||Newark, Delaware 19718|
|Bronson Battle Creek||Battle Creek, Michigan 49017|
|Cancer Care Associates-Norman||Norman, Oklahoma 73071|