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Status:

COMPLETED

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Acute Myeloid Leukemia

Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 ...

Detailed Description

PRIMARY OBJECTIVES: I. To assess the safety and tolerability of dasatinib 100 mg/day given after intensive induction (daunorubicin hydrochloride \[daunorubicin\]/cytarabine), and consolidation chemot...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    December 14 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 15 2021

    Estimated Enrollment :

    61 Patients enrolled

    Trial Details

    Trial ID

    NCT01238211

    Start Date

    December 14 2010

    End Date

    March 15 2021

    Last Update

    March 1 2023

    Active Locations (65)

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    Page 1 of 17 (65 locations)

    1

    Beebe Medical Center

    Lewes, Delaware, United States, 19958

    2

    Christiana Care Health System-Christiana Hospital

    Newark, Delaware, United States, 19718

    3

    AdventHealth Orlando

    Orlando, Florida, United States, 32803

    4

    Saint Joseph Medical Center

    Bloomington, Illinois, United States, 61701