Clinical trial NCT01609816 (phase 1, status: terminated)
Conditions: non-hodgkin's lymphoma, multiple, mycosis fungoides, hodgkin's lymphoma, multiple myeloma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, G35, M15.3, M67.49, M89.09, M89.59, M94.29, Q78.6, C84.07, C84.00, C84.02, C84.06, C84.03, C84.08, C84.09, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C90.01, C90.02, C90.00
Drugs: dasatinib
SMILES: CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1
Reason stopped: 
    low accrual. no analyses were performed
  
Eligibility criteria:

        Inclusion Criteria:

          -  Recipients of first ASCT for the treatment of hematologic malignancies (multiple
             myeloma, Hodgkin's and non Hodgkin's lymphoma)

          -  Patients must be between 100 to 180 days after ASCT

          -  Dasatinib use prior to ASCT is allowed

          -  Performance status >= 60%

          -  Presence of LGL clone prior to enrollment will not be an exclusion criterion if the
             LGL clone is < 25% of T cell population

          -  Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)

          -  Hepatic enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT]) =<
             2.5 times the institutional ULN

          -  Serum creatinine < 1.5 times the institutional ULN

          -  Hemoglobin >= 8 g/dL

          -  Absolute neutrophil counts >= 1,500 cells per uL

          -  Platelets >= 100,000 per uL

          -  Patient should be able to provide signed written informed consent; before any study
             procedures are performed, subjects will have the details of the study described to
             them, and they will be given a written informed consent document to read; then, if
             subjects consent to participate in the study, they will indicate that consent by
             signing and dating the informed consent document in the presence of study personnel;
             written consent will include a Health Insurance Portability and Accountability Act
             (HIPAA) form according to institutional guidelines

          -  Patient should be able to take oral medication (dasatinib must be swallowed whole)

        Exclusion Criteria:

          -  Patients who have evidence of disease progression before day 100 after ASCT

          -  Sex and reproductive status:

               -  Women of childbearing potential (WOCBP) who are unwilling or unable to use an
                  acceptable method to avoid pregnancy for the entire study period and for at least
                  4 weeks after the last dose of study drug

               -  Women who are pregnant or breastfeeding

               -  Women with a positive pregnancy test

               -  Sexually active fertile men not using effective birth control if their partners
                  are WOCBP

          -  Medical history and concurrent diseases:

          -  No malignancy (other than the one treated in this study) which required radiotherapy
             or systemic treatment within the past 5 years

          -  Concurrent medical condition which may increase the risk of toxicity, including:

               -  Pleural or pericardial effusion of any grade at the time of screening for study

               -  Cardiac symptoms; any of the following should be considered for exclusion:

                    -  Uncontrolled angina, congestive heart failure or myocardial infarction (MI)
                       (within 6 months)

                    -  Diagnosed congenital long QT syndrome

                    -  Any history of clinically significant ventricular arrhythmias (such as
                       ventricular tachycardia, ventricular fibrillation, or torsades de pointes)

                    -  Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 450
                       msec)

          -  History of significant bleeding disorder unrelated to cancer, including:

               -  Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)*
                  Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor
                  VIII antibodies)

               -  Ongoing or recent (=< 3 months) significant gastrointestinal bleeding

          -  Any previous history of >= grade 3 toxicity to dasatinib

          -  Prohibited treatments and or therapies

          -  Category I drugs that are generally accepted to have a risk of causing torsades de
             pointes including: (patients must discontinue drug 7 days prior to starting
             dasatinib):

               -  Quinidine, procainamide, disopyramide

               -  Amiodarone, sotalol, ibutilide, dofetilide

               -  Erythromycin, clarithromycin

               -  Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide

               -  Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone,
                  halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine

          -  Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy
             (discontinue St. Johns Wort at least 5 days before starting dasatinib)

          -  Patient agrees that intravenous (IV) bisphosphonates will be withheld for the first 8
             weeks of dasatinib therapy due to risk of hypocalcemia

          -  Other exclusion criteria:

          -  Prisoners or subjects who are involuntarily incarcerated

          -  Subjects who are compulsorily detained for treatment of either a psychiatric or
             physical (eg, infectious disease) illness