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

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