A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia.

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase IV
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCD ID
NCT00131313
Protocol IDs
POI-02818 (primary)
NIP-02-005
Study Sponsor
East Valley Oncology and Hematology Medical Group, Incorporated

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.

Objectives

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.

Treatment Sites in Georgia


Augusta Oncology - St. Sebastian Way
820 Saint Sebastian Way
Suite 3A
Augusta, GA 30901
706-821-2944
www.augonc.com

Spalding Oncology Service
230 West College Street
Suite D
Griffin, GA 30224
www.wellstar.org

Doctors:

Pravin C. Mehta MD
Glen Morehead MD