Efficacy and Safety of Nipent Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.

  • STATUS
    Recruiting
  • participants needed
    180
  • sponsor
    East Valley Hematology and Oncology Medical Group
Updated on 7 November 2020
Auerbach Hematology Oncology Associates, Inc. (15.9 mi away) Contact
lymphoid leukemia
rituxan

Summary

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.

Description

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.

Details
Treatment Nipent, Cytoxan, Rituxan
Clinical Study IdentifierNCT00131313
SponsorEast Valley Hematology and Oncology Medical Group
Last Modified on7 November 2020

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