Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/9/2019
Start Date:December 14, 2010

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A Phase II Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy Plus Dasatinib (NSC #732517) and Continuation Therapy With Dasatinib Alone in Newly Diagnosed Patients With Core Binding Factor Acute Myeloid Leukemia (AML)

This phase II trial studies the side effects and how well giving combination chemotherapy
together with dasatinib works in treating patients with newly diagnosed acute myeloid
leukemia. Drugs used in chemotherapy, such as daunorubicin hydrochloride and cytarabine, 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. Dasatinib may stop the
growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving
combination chemotherapy together with dasatinib may kill more cancer cells.

PRIMARY OBJECTIVES:

I. To assess the safety and tolerability of dasatinib 100 mg/day given after intensive
induction (daunorubicin hydrochloride [daunorubicin]/cytarabine), and consolidation
chemotherapy (high-dose cytarabine) and as single agent in maintenance therapy to newly
diagnosed patients with core binding factor acute myeloid leukemia (AML).

II. 30-day survival rate during induction (the lack of early/hypoplastic death).

III. The absence of pleural or pericardial effusion, and absence of liver toxicity that
exceeds grade 2.

SECONDARY OBJECTIVES:

I. To assess clinical outcomes such as event-free survival (EFS), complete response (CR)
rate, cumulative incidence of relapse (CIR), cumulative incidence of death (CID),
disease-free survival (DFS), and overall survival (OS).

II. To describe the frequency and severity of adverse events of patients treated on this
study during induction, consolidation, and continuation therapy.

III. To describe the interaction of pretreatment disease and patient characteristics
including morphology, cytogenetics, immunophenotype, molecular genetic features, white blood
cell (WBC) count and hemogram, and performance status on clinical outcomes.

OUTLINE:

INDUCTION THERAPY (course 1): Patients receive daunorubicin hydrochloride intravenously (IV)
on days 1-3, cytarabine IV continuously over 168 hours on days 1-7, and dasatinib orally (PO)
once daily (QD) on days 8-21. Patients with responsive disease on day 21 undergo
consolidation therapy, and patients with non-responsive disease on day 21 (bone marrow
cellularity >= 20 % and leukemia blasts >= 5%) receive a second course of induction therapy.

INDUCTION THERAPY (course 2): Patients receive daunorubicin hydrochloride IV on days 1-3,
cytarabine IV continuously over 120 hours on days 1-5, and dasatinib PO once a day on days
6-19. Patients achieving complete response receive consolidation therapy.

CONSOLIDATION THERAPY: Patients receive high-dose cytarabine IV over 3 hours on days 1, 3,
and 5, and dasatinib PO QD on days 6-26 or 7-27. Treatment repeats every 28 days for up to 4
courses in the absence of disease progression or unacceptable toxicity. Patients in complete
remission receive continuation therapy.

CONTINUATION THERAPY: Patients receive dasatinib PO on days 1-28. Treatment repeats every 28
days for 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 2 months for 2 years, every
3 months for 2 years, and then every year for up to 10 years from study entry.

Inclusion Criteria:

- Documentation of disease as assessed by the Alliance reference laboratory at the Ohio
State University per Cancer and Leukemia Group B (CALGB) 20202, molecular diagnosis of
core-binding factor (CBF) acute myeloid leukemia (AML) by reverse transcriptase
polymerase chain reaction (RT-PCR) positive for RUNX1-RUNX1T1 fusion transcript
resulting from t(8;21)(q22;q22) (or a variant form) or CBFB-MYH11 fusion transcript
resulting from inv(16)(p13.1q22) or t(16;16)(p13.1;q22) (any % bone marrow or blood
blasts render the diagnosis of CBF AML based on the World Health Organization [WHO]
classification)

- No prior chemotherapy for leukemia or myelodysplasia with the following exceptions:

- Emergency leukapheresis

- Emergency treatment for hyperleukocytosis with hydroxyurea,

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

- Growth factor/cytokine support/non-cytotoxic molecular-targeted agents

- AML patients with a history of antecedent myelodysplasia (MDS) remain eligible for
treatment on this trial

- Patients who have developed therapy related myeloid neoplasm (t-MN) after prior
radiation therapy or chemotherapy for another cancer or disorder are eligible

- Left ventricular ejection fraction >= lower limit of institutional normal by
multigated acquisition (MUGA) or echocardiogram (ECHO) scan

- Patients must not have had myocardial infarction within 6 months of registration

- Patients must not have had ventricular tachyarrhythmia within 6 months of registration

- Patients must have no major conduction abnormality (unless a cardiac pacemaker is
present)

- Bilirubin must not be < 2.5 times upper limit of normal

- Patients must be non-pregnant and non-nursing; pregnant or nursing patients may not be
enrolled; women of childbearing potential (WOCBP) must have a negative serum or urine
pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to
registration; women of child-bearing potential must either commit to continued
abstinence from heterosexual intercourse or begin TWO acceptable methods of birth
control - one highly effective method (e.g., intrauterine device [IUD], hormonal,
tubal ligation, or partner's vasectomy), and one additional effective method (e.g.,
latex condom, diaphragm, or cervical cap) - AT THE SAME TIME, before she begins
dasatinib therapy, during treatment and at least 12 weeks after treatment is complete;
"Women of childbearing potential" is defined as a sexually active mature woman who has
not undergone a hysterectomy or who has had menses at any time in the preceding 24
consecutive months

- Patients with congenital long QT syndrome or non-congenital corrected QT (QTc)
prolongation (defined as a QTc interval consistently equal to or greater than 480
msecs) that cannot be corrected by infusion of electrolytes and/or discontinuation of
other medications prior to start of treatment are excluded
We found this trial at
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1304 Franklin Avenue
Normal, Illinois 61761
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361 Old Belgrade Road
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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
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666 Elm Street
Buffalo, New York 14263
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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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22 South Greene Street
Baltimore, Maryland 21201
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489 State St
Bangor, Maine 04401
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265 Fremont St
Battle Creek, Michigan 49017
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Big Rapids, Michigan 49307
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
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Bloomington, Illinois 61701
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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
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617-632-3000
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Canton, Illinois 61520
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
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1454 North County Road 2050
Carthage, Illinois 62321
(217) 357-8500
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
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1200 West Harrison Stree
Chicago, Illinois 60607
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1 Hospital Dr
Columbia, Missouri 65212
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Decatur, Illinois 62526
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Elkton, Maryland 21921
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Eureka, Illinois 61530
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101 S Major St
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3315 N Seminary St
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2700 Wayne Memorial Dr
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100 Michigan St NE
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615 N. Promenade Street
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Lake Success, New York 11042
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450 Lakeville Road
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1 Medical Center Dr
Lebanon, New Hampshire 03756
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424 Savannah Rd
Lewes, Delaware 19958
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501 E Grant
Macomb, Illinois 61455
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525 E Grant St
Macomb, Illinois 61455
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Muskegon, Michigan 49444
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270-05 76th Ave
New Hyde Park, New York 11040
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New York, New York 10065
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4755 Ogletown-Stanton Road
Newark, Delaware 19718
302-733-1000
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Normal, Illinois 61761
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407 East Vernon Ave.
Normal, Illinois 61761
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Orlando, Florida 32803
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1200 Starfire Drive
Ottawa, Illinois 61350
815-431-9270
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603 S 13th St
Pekin, Illinois 61554
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Peoria, Illinois 61637
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5409 N Knoxville Ave
Peoria, Illinois 61614
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8940 Wood Sage Rd
Peoria, Illinois 61615
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8940 Wood Sage Rd
Peoria, Illinois 61615
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221 NE Glen Oak Ave
Peoria, Illinois 61636
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925 West Street
Peru, Illinois 61354
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4391 Venture Dr.
Peru, Illinois 61354
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530 Park Ave E
Princeton, Illinois 61356
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300 N Patterson Rd
Reed City, Michigan 49677
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660 S Euclid Ave
Saint Louis, Missouri 63110
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600 First Street
Spring Valley, Illinois 61362
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105 Sixth St
Traverse City, Michigan 49684
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
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