A Phase II Study of Clofarabine in Patients With Aggressive Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the efficacy of clofarabine as measured by response rate in patients with aggressive non-Hodgkin's lymphoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kristie Blum; Ohio State University Comprehensive Cancer Center
• Treatments: Clofarabine

Criteria

Inclusion Criteria:

• Must have histologically confirmed aggressive NHL

• B-cell NHL must be relapsed/ refractory

• T-cell & NK-cell and transformed lymphoma eligible at DX

• Patients with B-cell NHL (ie, diffuse large B-cell lymphoma, mantle cell lymphoma, and Burkitt's lymphoma) must have relapsed or refractory disease after at least 1 prior therapy.

• Patients previously treated with radioimmunotherapy (ie, ibritumomab tiuxetan [Zevalin] or tositumomab [Bexxar]) or prior stem cell transplant (SCT) are eligible.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

• Life expectancy of at least 12 weeks.

• Laboratory values obtained ≤ 7 days prior to registration:

• Absolute neutrophil count (ANC) ≥ 1500/mm3

• Platelets ≥ 100,000/mm3

• Total bilirubin ≤ upper limit of normal (ULN)

• Alkaline phosphatase ≤ 2 × ULN

• Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2 × ULN

• Serum creatinine ≤ ULN

Exclusion Criteria:

• No prior treatment with clofarabine.

• Full recovery from all acute toxicities associated with prior chemotherapy, radiotherapy, or immunotherapy.- Patients with 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) are not eligible.

• Cardiac function (i.e. left ventricular ejection fraction) ≥ 50% on pretreatment radionuclide ventriculography (RVG) or echocardiogram.

• Women that are pregnant or breastfeeding.

• Known HIV disease.

• No CNS lymphoma