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NCT00131313 Clinical Trial

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

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.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00131313
Other study ID # POI-02818
Secondary ID NIP-02-005
Status Recruiting
Phase Phase 4
First received August 16, 2005
Last updated August 17, 2005
Start date January 2003
Est. completion date April 2009

Study information
Verified date August 2005
Source East Valley Hematology and Oncology Medical Group
Contact Tracy Latimer
Phone 720-917-7478
Email tracyl@pharmatech.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date April 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Stage II, III or IV Chronic Lymphocytic Leukemia

- Disease requires chemotherapeutic treatment

- CT or MRI scan confirming measurable tumor size

- Documentation of CD markers

- Up to one prior treatment regimen

- Expected survival greater than 6 months

- ECOG performance status of 0-2

- Adequate renal, bone marrow and liver functions

- Negative pregnancy test (females of childbearing potential)

- Must agree to use acceptable birth control, if fertile

- Must complete Informed Consent

- No heart disease and must have adequate cardiac function

- Must test negative for viral Hepatitis B and C

Exclusion Criteria:

- More than one prior treatment for Chronic Lymphocytic Leukemia

- Known sensitivity to Nipent, Rituxan or Cytoxan or any component of these drugs

- Known HIV or AIDS illness

- Thyroid disease requiring medication

- History of any malignancy that could affect the diagnosis or assessment of the study treatment

- Pregnancy or breast feeding

- Evidence of Hepatitis B or C infection

- Inability to comply with the requirements of the study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Nipent, Cytoxan, Rituxan

Locations
Country Name City State
United States Cancer Outreach Associates, PC Abingdon Virginia
United States Summa Health System Hospitals Akron Ohio
United States Augusta Oncology Associates, PC Augusta Georgia
United States Auerbach Hematology Oncology Associates, Inc. Baltimore Maryland
United States Chesapeake Oncology Hematology Associates Baltimore Maryland
United States Greater Baltimore Medical Center Baltimore Maryland
United States Mid Dakota Clinic/Odyssey Research Bismarck North Dakota
United States St Luke's Mountain States Tumor Institute Boise Idaho
United States Palm Beach Institute of Hematology and Oncology Boynton Beach Florida
United States Branson Oncology Clinic Branson Missouri
United States East Valley Hematology and Oncology Medical Group Burbank California
United States Nashat Y. Gabrail, MD, Inc. Canton Ohio
United States Sierra Nevada Oncology Care Carson City Nevada
United States Charleston Hematology Oncology, PA Charleston South Carolina
United States The Center for Cancer and Hematologic Disease Cherry Hill New Jersey
United States The Family Cancer Center Collierville Tennessee
United States The Oncology Clinic, PC Colorado Springs Colorado
United States South Carolina Oncology Associates Columbia South Carolina
United States Bay Area Cancer Research Group Concord California
United States Sambandam and Joseph Associates, Inc Cranston Rhode Island
United States Mile High Oncology Denver Colorado
United States Ellioth Fishkin, MD Elizabeth New Jersey
United States Genesee Cancer & Blood Disease Treatment Center, PC Flint Michigan
United States JPS Center for Cancer Care Fort Worth Texas
United States Lalita Pandit, MD, Inc. Fountain Valley California
United States Pacific Coast Hematology/Oncology Medical Group, Inc. Fountain Valley California
United States Robert A. Moss, M.D. FACP, Inc. Fountain Valley California
United States West Michigan Regional Cancer & Blood Center Freesoil Michigan
United States C. Michael Jones, MD, PC Germantown Tennessee
United States Spectrum Health Hospitals Grand Rapids Michigan
United States Spalding Oncology Services Griffin Georgia
United States Oncology Hematology Assoc. of Northern Illinois Gurnee Illinois
United States Kentucky Cancer Clinic Hazard Kentucky
United States Indiana Oncology Hematology Consultants Indianapolis Indiana
United States Integrated Community Oncology Network Jacksonville Florida
United States Osceola Cancer Center Kissimmee Florida
United States Arnett Cancer Care Lafayette Indiana
United States Nevada Cancer Center Las Vegas Nevada
United States Cache Valley Cancer Treatment & Research Clinic, Inc. Logan Utah
United States Metropolitan Hematology Oncology Medical Group Los Angeles California
United States Westchester Hematology Oncology Associates Mount Kisco New York
United States Northwest Alabama Cancer Center, PC Muscle Shoals Alabama
United States Cancer Care Center New Albany Indiana
United States Pasco Hernando Oncology Associates, PA New Port Richey Florida
United States Pasco Pinellas Cancer Center New Port Richey Florida
United States North County Oncology Oceanside California
United States Ventura County Hematology Oncology Specialists Oxnard California
United States Cancer and Blood Institute Medical Group Rancho Mirage California
United States Virginia Oncology Care, PC Richlands Virginia
United States St. Louis Hematology Oncology Specialists, Inc. St. Louis Missouri
United States St. Teresa Comprehensive Cancer Center Stockton California
United States Medical Group of North County Vista California

Sponsors (4)
Lead Sponsor Collaborator
East Valley Hematology and Oncology Medical Group Astex Pharmaceuticals, Mena, Raul, M.D., Pharmatech Oncology

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy response rate
Secondary Time to progression
Secondary Time to treatment failure
Secondary Toxicity
Secondary Incidence and severity of adverse events
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