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

Completed · Phase 2

Conditions studied: Non-Hodgkin's Lymphoma

In brief

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

Key facts

Study ID

NCT00201669

Run by

Ohio State University Comprehensive Cancer Center

People needed

6

Starts

2004-10-01

Expected to finish

2006-06-01

Last updated by the study team

2017-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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