Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermediate-Grade B-Cell Lymphoma

Exclusion Criteria

• •Measurable disease, defined by the Cheson lymphoma criteria.
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• •Life expectancy greater than 12 weeks
• •Laboratory values obtained ≤2 weeks prior to entry
• •* Absolute neutrophil count (ANC) ≥ 1000 x 10 9/L
• •* White blood cell (WBC) count \> 2.5 x 10 9/L
• •* Platelets ≥ 75 x 10 9/L
• •* Hemoglobin (Hg) \> 9.0 g/dL
• •* Total bilirubin ≤2.0 mg/dL
• •* Aspartate transaminase (AST)/alanine transaminase (ALT) ≤3 × upper limit of normal (ULN)
• •* Serum creatinine ≤2.0 mg/dL
• •Normal cardiac function, defined as an ejection fraction ≥45% determined by pretreatment radionuclide ventriculography (RVG) or echocardiogram.
• •Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
• •Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
• •Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
• •Previously untreated B-cell lymphoma.
• •Received previous treatment with clofarabine.
• •Patients with known AIDS-related or HIV-positive lymphoma.
• •Autologous bone marrow or stem cell transplant within 6 months of study entry.
• •Prior radiotherapy to the only site of measurable disease.
• •Any medical condition that requires chronic use of oral high-dose corticosteroids greater than 20 mg/day prednisone.
• •Active autoimmune thrombocytopenia.
• •Use of investigational agents within 30 days or any anticancer therapy within 3 weeks before study entry. The patient must have recovered from all acute toxicities from any previous therapy.
• •Patients with an active, uncontrolled systemic infection considered to be opportunistic, life threatening, or clinically significant at the time of treatment or with a known or suspected fungal infection (ie, patients on parenteral antifungal therapy).
• •Active secondary malignancy.
• •Pregnant or lactating patients.
• •Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
• •Patients with active or untreated central nervous system (CNS) lymphoma.