dose escalation study of clofarabine in patients with relapsed or refractory low grade or intermediate-grade b-cell lymphoma

Conditions: B-Cell Lymphoma

Summary: clofarabine is a new chemotherapy drug which was fda approved for the treatment of acute lymphocytic leukemia in children. this study is being done to see if clofarabine works in adult patients with b-cell types of lymphoma. this research is being done to develop new treatments for patients with lymphoma whose cancer has returned or resisted treatment with previous chemotherapy.


Eligibility criteria:
inclusion criteria: * adult patients who are at least 18 years old * histologically confirmed low grade or intermediate-grade b-cell lymphoma * relapsed or refractory to at least one standard chemotherapy regimen. patients who have received rituximab alone without having received a cytotoxic agent are not eligible. * 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. exclusion criteria: * 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.