Sorafenib for the Treatment of Chronic Lymphocytic Leukemia (CLL)

This is an interventional treatment trial for Chronic Lymphocytic Leukemia Read More

Inclusion Criteria:

• Diagnosis of relapsed or refractory CLL.
• Experiencing progressive disease with an iwCLL-WG indication to receive therapy.
• Age ≥ 18 years.
• ECOG performance status ≤ 2 at study entry.
• Adequate organ and marrow function as defined below:
• platelets ≥ 50 x 109/L
• serum creatinine ≤ 1.5 mg/dL
• total bilirubin ≤ 1.5 mg/dL
• AST(SGOT)/ALT(SPGT) ≤ 2 X institutional upper limit of normal or if known liver involvement <5X institutional upper limit of normal
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

• No investigational agents within 28 days prior to entering the study.
• No concurrent use of other anti-cancer agents or treatments.
• No congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (beginning within the last 3 months) or myocardial infarction within the past 6 months.
• No known brain metastases (progressive neurologic dysfunction may confound the evaluation of neurologic and other adverse events).
• No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• No uncontrolled hypertension defined as systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
• No known active Hepatitis or HIV.
• No history of allergic reactions attributed to compounds sorafenib or its excipients.
• No uncontrolled intercurrent illness such as ongoing or active infection (fungal, bacterial, and/or viral), CTCAE grade 2 or greater.
• No thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
• No serious non-healing wound, ulcer, or bone fracture.
• No major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
• No condition that may impair the patient's ability to swallow whole pills.
• Patient must not have any malabsorption problem.
• Patients receiving St. John's Wort or rifampin (rifampicin) are ineligible.
• Patients with uncontrolled Autoimmune Hemolytic Anemia (AIHA) or autoimmune thrombocytopenia (ITP) are ineligible.
• Patients must not be experiencing psychiatric illness/social situations that would limit compliance with study requirements.
• Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
• Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from CLL except cervical cancer in-situ, treated basal cell carcinoma, squamous cell carcinoma of the skin, or superficial bladder tumor (Ta and Tis). Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before study entry are allowed. All cancer treatments must be completed at least 3 years prior to study entry (ie, signature date of the informed consent form).