A Study of Motexafin Gadolinium for the Treatment of Chronic Lymphocytic Leukemia (CLL)

Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

The purpose of this study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have chronic lymphocytic leukemia (CLL) that has come back after treatment or that has stopped responding to treatment.

Inclusion Criteria:

• At least 18 years old
• Refractory or relapsed CLL
• ECOG performance status score of 0, 1, or 2
• Each patient must sign a study-specific informed consent form

Exclusion Criteria:

Laboratory values of:

• Platelet count <30,000/uL
• AST or ALT >2 x the upper limit of normal (ULN)
• Total bilirubin >2 x ULN
• Creatinine >2.0 mg/dL
• Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy within 21 days before beginning study treatment
• Women who are pregnant or lactating