Phase I/II Trial of Weekly Motexafin Gadolinium (MGd) for Patients With Refractory or Relapsed 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:

- Refractory disease: progressive disease while on therapy

- 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 mg/dL

- Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (> 10 mg
oral prednisone or equivalent), or systemic biologic anticancer therapy within 21
days before beginning study treatment

- Major surgery or hospitalization for a serious illness within the last 3 months

- Greater than three prior regimens (where a regimen is defined as a treatment for
CLL/SLL given initially or after disease progression)

- Prior malignancy requiring current or prior treatment within the past 5 years, except
for cervical neoplasia in situ and non-melanomatous skin cancer

- Uncontrolled hypertension