Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia



Status:Active, not recruiting
Conditions:Blood Cancer, Women's Studies, Hematology
Therapuetic Areas:Hematology, Oncology, Reproductive
Healthy:No
Age Range:60 - Any
Updated:2/8/2019
Start Date:November 16, 2011

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A Randomized Phase II Trial of Decitabine-Based Induction Strategies for Patients >/= 60 Years Old With Acute Myeloid Leukemia (AML)

This randomized phase II trial studies how well giving decitabine with or without bortezomib
works in treating older patients with acute myeloid leukemia. Drugs used in chemotherapy,
such as decitabine, work in different ways to stop the growth of cancer cells, either by
killing the cells,by stopping them from dividing, or by stopping them from spreading.
Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for
cell growth. It is not yet known whether decitabine works better when given with or without
bortezomib in treating acute myeloid leukemia.

PRIMARY OBJECTIVE:

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.

SECONDARY OBJECTIVES:

I. To determine the rate of complete remission (CR and CR + incomplete blood count recovery
[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, white blood cell (WBC) count, blood and bone
marrow blast count, age, performance status and comprehensive geriatric assessment on
clinical outcomes.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: 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 not achieving CR or CR with
CRi proceed to continuation therapy. Patients achieving CR or CR with CRi proceed to
maintenance therapy.

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.

MAINTENANCE 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.

ARM B: 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 11. Treatment repeats every 28
days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients
not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CR with CRi
proceed to maintenance 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
unacceptable toxicity.

MAINTENANCE 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
unacceptable toxicity.

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 a maximum of 10 years from study entry.

Inclusion Criteria:

- Unequivocal pathologic diagnosis of AML (>= 20% blasts in the bone marrow based on
World Health Organization [WHO] criteria) EXCLUDING:

- Acute promyelocytic leukemia t(15;17)(q22;q12); PML-RARA

- Acute myeloid leukemia with t(8;21)(q22;q22); RUNX1-RUNXT1 as determined by the
Ohio State University (OSU) Molecular Reference Laboratory, per Cancer and
Leukemia Group B (CALGB) 20202; however patients who (1) are >= 75 years; and/or
(2) have an ejection fraction of < 40%; and/or (3) have a performance status of >
2, may be registered to CALGB 20202 and registered and treated on CALGB 11002
prior to receiving the FLT3 mutation and core-binding factor (CBF) molecular
screening results from CALGB 20202

- Acute myeloid leukemia with inv(16)(p13.1;q22) or t(16;16)(p13.1;q22); CBFB-MYH11
as determined by the OSU Molecular Reference Laboratory, per CALGB 20202; however
patients who (1) are >= 75 years; and/or (2) have an ejection fraction of < 40%;
and/or (3) have a performance status of > 2, may be registered to CALGB 20202 and
registered and treated on CALGB 11002 prior to receiving the FLT3 mutation and
CBF molecular screening results from CALGB 20202

- Absence of FLT3 mutation (ITD or point mutation) determined by the OSU Molecular
Reference Laboratory, per CALGB 20202; however patients who (1) are >= 75 years;
and/or (2) have an ejection fraction of < 40%; and/or (3) have a performance status of
> 2, may be registered to CALGB 20202 and registered and treated on CALGB 11002 prior
to receiving the FLT3 mutation and CBF molecular screening results from CALGB 20202

- No prior treatment for AML except:

- Emergency leukapheresis

- Emergency treatment for hyperleukocytosis with hydroxyurea

- Cranial radiotherapy (RT) for central nervous system (CNS) leukostasis (one dose
only)

- Growth factor/cytokine support

- AML patients with an antecedent hematologic disorder (AHD) or myelodysplastic syndrome
(MDS) are eligible for this trial provided that they have not received treatment for
their AHD or MDS with cytotoxic chemotherapy (e.g., cytarabine, daunorubicin, etc.),
decitabine, or bortezomib; patients may have been previously treated with azacitidine
if their last dose was >= 90 days prior to starting 11002

- AML patients with therapy-related myeloid neoplasms (t-MN) are eligible if they have
not received radiation therapy or chemotherapy (not including hormonal therapy) for
their primary malignancy or disorder for > 6 months
We found this trial at
53
sites
361 Old Belgrade Road
Augusta, Maine 04330
(207) 621-6100
Harold Alfond Center for Cancer Care MaineGeneral's Harold Alfond Center for Cancer Care (HACCC) is...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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Manhasset, NY
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489 State St
Bangor, Maine 04401
(207) 973-7000
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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Big Rapids, Michigan 49307
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Massachusetts General Hospital Cancer Center An integral part of one of the world
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Camden, NJ
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Chapel Hill, North Carolina 27599
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Charlotte, North Carolina 28204
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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1 Hospital Dr
Columbia, Missouri 65212
(573) 882-2100
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Elkton, Maryland 21921
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2700 Wayne Memorial Dr
Goldsboro, North Carolina 27534
(919) 736-1110
Wayne Memorial Hospital Wayne Memorial Hospital, an affiliate of Wayne Health Corporation, is home to...
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100 Michigan St NE
Grand Rapids, Michigan 49503
(616) 391-1774
Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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Grand Rapids, Michigan 49503
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Greenville, South Carolina 29605
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Greenville, South Carolina 29605
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Greenville, South Carolina 29615
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701 Grove Rd
Greenville, South Carolina 29605
(864) 455-7000
Greenville Memorial Hospital Greenville Memorial Medical Campus is a regional referral center for the diagnosis...
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Hendersonville, North Carolina 28791
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600 Moye Boulevard
Kinston, North Carolina 28501
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Lake Success, New York 11042
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450 Lakeville Road
Lake Success, New York 11042
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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424 Savannah Rd
Lewes, Delaware 19958
(302) 645-3300
Beebe Medical Center Located in beautiful historic Lewes, Delaware, near Rehoboth Beach, Beebe Healthcare offers...
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Mountain View, California 94040
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Muskegon, Michigan 49444
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270-05 76th Ave
New Hyde Park, New York 11040
(718) 470-7480
Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
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445 E 69th St
New York, New York 10021
(212) 746-1067
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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New York, New York 10029
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4755 Ogletown-Stanton Road
Newark, Delaware 19718
302-733-1000
Christiana Care Health System - Christiana Hospital A 913-bed, 1.3-million-square-foot, modern facility in Newark, Delaware,...
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701 E Robinson St
Norman, Oklahoma 73071
(405) 321-4644
Cancer Care Associates - Norman Now under the new name of Tulsa Cancer Institute, our...
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Oklahoma City, Oklahoma 73120
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Orlando, Florida 32803
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300 N Patterson Rd
Reed City, Michigan 49677
(231) 832-3271
Spectrum Health Reed City Hospital At Spectrum Health Reed City Hospital, you have access to...
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Spartanburg, South Carolina 29307
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105 Sixth St
Traverse City, Michigan 49684
(231) 935-5000
Munson Medical Center There’s no place quite like northern Michigan, and there is no other...
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Washington, District of Columbia 20007
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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