Study of Motexafin Gadolinium (MGd) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Leukemia, Lymphoma, Motexafin Gadolinium, Relapsed Chronic Lymphocytic Leukemia, Relapsed Chronic Lymphocycic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Small Lymphocytic Lymphoma
Eligibility Criteria
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
Sites / Locations
- Northwestern University
- The Mayo Clinic
- The Ohio State University