Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia.
This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA.
Chronic Lymphocytic Leukemia (CLL) is the most common form of adult leukemia in the U.S.
Recent experience with Nipent in conjunction with Rituxan has shown that this combination is
well tolerated and is clinically promising. It is expected that the addition of Cytoxan in
patients with previously untreated CLL and patients who have relapsed or failed prior
therapy may benefit from combined therapy using Nipent, Cytoxan and Rituxan. It is unknown
how the addition of Cytoxan will affect the toxicity profile of the Rituxan and Nipent
regimen, however, patients will be monitored for toxicities. It is expected that bone marrow
toxicities will not increase to unreasonable levels.
The primary objective of the study is to determine the overall efficacy response rate
following treatment with Nipent, Cytoxan and Rituxan of patients with previously untreated
or treated CLL. The secondary objectives of the study are to determine the duration of
response, time to progression, time to treatment failure and to evaluate the toxicity of
this combination of drugs and the incidence and severity of adverse events.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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