Dasatinib for Immune Modulation After Donor Stem Cell Transplant for Hematologic Malignancies

Exclusion Criteria

• •Recipient of mismatched (allele or antigen level) graft in more than one loci of HLAA, -B, -C or -DR loci will not be eligible, i.e. recipients of 2-antigen or 2-allelele mismatched graft
• •Patients on investigational therapy for graft-versus-host disease (GVHD)
• •Patients with uncontrolled acute or chronic GVHD or refractory disease not responding to conventional therapy
• •Patients who have evidence of disease progression before day 100 after ASCT
• •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
• •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 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 IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia
• •Prisoners or subjects who are involuntarily incarcerated
• •Subjects who are compulsorily detained for treatment of either a psychiatric or physical (egg, infectious disease) illness