Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
This study enrolled participants with Philadelphia chromosome positive (Ph+)chronic myelogenous leukemia (CML) or Ph+ acute lymphoblastic leukemia (ALL) who had demonstrated hematologic resistance or intolerance to imatinib mesylate (Gleevec) and had experienced clinical benefit (in Investigator's opinion) on protocol CA180002.
Signed written informed consent
Previous treatment with dasatinib on protocol CA180-002 and receiving clinical benefit in the opinion of the investigator
Completed a minimum of 3 months on protocol CA180-002
Eastern Cooperative Oncology Group (ECOG)performance status 0, 1, or 2 (See Appendix 1)
Prior history of Ph+ chronic, accelerated, or blast phase CML or Ph+ ALL
You may not be if
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 up to 12 weeks after the study
WOCBP using a prohibited contraceptive method
Women who are pregnant or breastfeeding
Met the criteria as defined in protocol CA180-002 for discontinuation of therapy which includes:
Withdrawal of informed consent (subject's decision to withdraw for any reason)
Any clinical adverse event, laboratory abnormality or intercurrent illness which, in the opinion of the investigator, indicates that continued treatment with dasatinib is not in the best interest of the subject
Imprisonment or the compulsory detention for treatment of either a psychiatric or physical (e.g., infectious disease) illness
Medical History and Concurrent Diseases
A serious uncontrolled medical disorder or active infection which would impair the ability of the patient to receive protocol therapy;
Uncontrolled angina within 3 months
Diagnosed or suspected 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)
Uncontrolled hypertension
Dementia or altered mental status that would prohibit the understanding or rendering of informed consent;
History of significant bleeding disorder unrelated to CML, including:
1. Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
2. Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
Physical and Laboratory Test Findings
Total bilirubin ≥ 1.5 mg/dl
alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2 times the institutional upper limits of normal
Serum creatinine ≥ 1.5 times the institutional upper limits of normal
Prohibited Therapies and/or Medications
Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes including:
Medications that inhibit platelet function and any non-steroidal anti-inflammatory drug) or anticoagulants are prohibited unless a previous exception on CA180-002 was granted by the medical monitor. Subjects taking anagrelide for thrombocytosis due to CML are eligible for this protocol
Clareo Health | Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Study
