Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Study

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Leukemia

Treatments

Drug: Dasatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00978731

CA180-039

Details and patient eligibility

About

To determine the long term safety and tolerability of dasatinib exposure in subjects previously treated in CA180-002.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Inclusion Criteria:

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

Exclusion Criteria:

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:
- quinidine, procainamide, disopyramide
- amiodarone, sotalol, ibutilide, dofetilide
- erythromycins, clarithromycin
- chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
- cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
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