Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
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)
5 other identifiers
interventional
61
1 country
65
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2010
Longer than P75 for phase_2
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2010
CompletedFirst Posted
Study publicly available on registry
November 10, 2010
CompletedStudy Start
First participant enrolled
December 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedResults Posted
Study results publicly available
August 12, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2021
CompletedMarch 1, 2023
January 1, 2023
2.5 years
November 9, 2010
July 21, 2014
January 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
30 Day Survival Rate
Percentage of participants who were alive 30 days after starting induction treatment.
30 days
Secondary Outcomes (6)
Event-free Survival
1 year
Complete Response Rate
60 months
Cumulative Incidence of Relapse
60 months
Cumulative Incidence of Death
36 months
Disease-free Survival
3 years
- +1 more secondary outcomes
Study Arms (1)
Treatment (daunorubicin hydrochloride, cytarabine, dasatinib)
EXPERIMENTALINDUCTION THERAPY (course 1): Patients receive daunorubicin hydrochloride IV on days 1-3, cytarabine IV continuously over 168 hours on days 1-7, and dasatinib PO 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 QD 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.
Interventions
Given IV
Given PO
Given IV
Correlative studies
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Graham Hospital Association
Canton, Illinois, 61520, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
University of Illinois
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Heartland Cancer Research NCORP
Decatur, Illinois, 62526, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Mcdonough District Hospital
Macomb, Illinois, 61455, United States
Bromenn Regional Medical Center
Normal, Illinois, 61761, United States
Carle Cancer Institute Normal
Normal, Illinois, 61761, United States
Illinois CancerCare-Community Cancer Center
Normal, Illinois, 61761, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois Valley Hospital
Peru, Illinois, 61354, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, 61362, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Christiana Care - Union Hospital
Elkton, Maryland, 21921, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, 49307, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, 49503, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Mercy Health Mercy Campus
Muskegon, Michigan, 49444, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Northwell Health NCORP
Lake Success, New York, 11042, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
Related Publications (2)
Marcucci G, Geyer S, Laumann K, Zhao W, Bucci D, Uy GL, Blum W, Eisfeld AK, Pardee TS, Wang ES, Stock W, Kolitz JE, Kohlschmidt J, Mrozek K, Bloomfield CD, Stone RM, Larson RA. Combination of dasatinib with chemotherapy in previously untreated core binding factor acute myeloid leukemia: CALGB 10801. Blood Adv. 2020 Feb 25;4(4):696-705. doi: 10.1182/bloodadvances.2019000492.
PMID: 32092139DERIVEDYin J, LaPlant B, Uy GL, Marcucci G, Blum W, Larson RA, Stone RM, Mandrekar SJ. Evaluation of event-free survival as a robust end point in untreated acute myeloid leukemia (Alliance A151614). Blood Adv. 2019 Jun 11;3(11):1714-1721. doi: 10.1182/bloodadvances.2018026112.
PMID: 31171508DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Guido Marcucci, M.D.
- Organization
- The Ohio State University
Study Officials
- PRINCIPAL INVESTIGATOR
Guido Marcucci
Alliance for Clinical Trials in Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2010
First Posted
November 10, 2010
Study Start
December 14, 2010
Primary Completion
July 1, 2013
Study Completion
March 15, 2021
Last Updated
March 1, 2023
Results First Posted
August 12, 2014
Record last verified: 2023-01