Expired Study
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Duarte, California 91010


Purpose:

A Study of Bafetinib as Treatment for Patients with Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL).


Study summary:

Bafetinib is a dual protein kinase inhibitor, targeting both bcr/abl and Lyn kinases. B-cell chronic lymphocytic leukemia cells overexpress Lyn kinase compared to normal B lymphocytes as well as acute leukemias (ALL and AML), and inhibition of Lyn kinase induces apoptosis in cultures of B-CLL cells. Thus, bafetinib may stop the growth of B-CLL cells by inhibiting Lyn kinase, the molecule that couples the B cell receptor to downstream signaling.


Criteria:

Inclusion Criteria: - Age ≥18 years, male or female. - B-cell chronic lymphocytic leukemia meeting the WHO criteria. - Relapsed or refractory disease with at least one of the following criteria: *progression after at least one course of a purine nucleoside analog (fludarabine phosphate, cladribine, pentostatin) - progression after at least one course of an alkylating agent (cyclophosphamide or chlorambucil) - relapse within 12 months after at least one course of either a purine nucleoside or an alkylating agent. - Capable of providing informed consent and complying with trial procedures. - ECOG performance status 0-2. - Requires chemotherapy for disease as shown by any of the following criteria: - measurable and progressive lymphocytosis - measurable and progressive lymphadenopathy (lymph node ≥2 cm in a single diameter) - either weight loss ≥10% within the past 6 months or extreme fatigue due to leukemia - fevers ≥100.5 degrees F for 2 weeks with no source of infection - night sweats with no evidence of infection - progressive marrow failure (worsening anemia with hemoglobin <10 gm/dL and/or thrombocytopenia with platelet count <100,000/mm3) - massive or progressive splenomegaly (spleen >6 cm below left costal margin). - Women must not be able to become pregnant (e.g. post menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. [Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.] - Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. - Accessibility to the site. Exclusion Criteria: - Chemotherapy, antibody therapy, surgery within 4 weeks of study enrollment. - Exposure to any investigational agent within 30 days of the Screening Visit. - Known CNS disease. - Concurrent active malignancies except basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix. - Laboratory values: Screening creatinine clearance (calculated by Cockcroft Gault formula) of less than 50 mL/minute, alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC) count <3500/mm3, absolute neutrophil count <1000/mm3, hematocrit level <33% for females or <35% for males. - Clinically evident congestive heart failure >class II of the New York Heart Association (NYHA) guidelines. - Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V. - History or signs of active coronary artery disease with or without angina pectoris. - Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial scintigram) or ultrasound determined absolute left ventricular ejection fraction (LVEF) <45% of predicted. - Known HIV infection. - Uncontrolled active, infection. - Major surgery within 3 weeks prior to treatment. - Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results. - Any condition that in the opinion of the Investigator is unstable and could jeopardize the subject's participation in the study.


NCT ID:

NCT01144260


Primary Contact:

Study Director
Daniel Levitt, M.D., Ph.D.
CytRx


Backup Contact:

N/A


Location Contact:

Duarte, California 91010
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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