Study of Motexafin Gadolinium (MGd) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Inclusion Criteria:

• ≥ 18 years old
• CLL as defined by the NCI 96 criteria (exception; patients may have bright surface immunoglobulin staining if negative for t[11;14] translocation or cyclin D1) or SLL as defined by WHO classification criteria and is refractory or relapsed as defined by one of the following: 1) Refractory disease- progressive disease while on therapy, or 2) Relapsed disease progressive disease after at least one treatment course of therapy with disease response or stabilization
• ECOG performance status score of 0, 1, or 2
• Willing and able to provide written informed consent

Exclusion Criteria:

Laboratory Values of:

• Platelet count < 30,000/µL
• AST or ALT > 2 x ULN (upper limit of normal)
• Total bilirubin > 2 x ULN
• Creatinine > 2.0 mg/dL

and

• Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment
• Greater than three prior regimens (where a regimen is defined as a treatment for CLL/SLL given initially or after disease progression)
• Uncontrolled hypertension
• Known history of porphyria (testing not required at screening)
• Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening)
• Known history of HIV infection (testing not required at screening)
• Pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
• Woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection
• Physical or mental condition that makes patient unable to complete specified follow-up assessments