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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CytRx
• Treatments: Bafetinib

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.