Chronic Lymphocytic Leukemia Clinical Trial

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

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 (leukemia-cll/" >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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 4

Estimated Enrollment:

180

Study ID:

NCT00131313

Recruitment Status:

Unknown status

Sponsor:

East Valley Hematology and Oncology Medical Group

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There are 50 Locations for this study

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Northwest Alabama Cancer Center, PC
Muscle Shoals Alabama, 35661, United States More Info
James Daugherty, MD
Contact
James Daugherty, MD
Principal Investigator
East Valley Hematology and Oncology Medical Group
Burbank California, 91505, United States More Info
Raul R Mena, MD
Contact
Raul R Mena, MD
Principal Investigator
Bay Area Cancer Research Group
Concord California, 94520, United States More Info
Robert L Robles, MD
Contact
Robert L Robles, MD
Principal Investigator
Lalita Pandit, MD, Inc.
Fountain Valley California, 92708, United States More Info
Lalita Pandit, MD
Contact
Lalita Pandit, MD
Principal Investigator
Pacific Coast Hematology/Oncology Medical Group, Inc.
Fountain Valley California, 92708, United States More Info
Glen R Justice, MD
Contact
Glen R Justice, MD
Principal Investigator
Robert A. Moss, M.D. FACP, Inc.
Fountain Valley California, 92708, United States More Info
Robert A Moss, MD, FACP
Contact
Robert A Moss, MD, FACP
Principal Investigator
Metropolitan Hematology Oncology Medical Group
Los Angeles California, 90057, United States More Info
Peter S Kennedy, MD
Contact
Peter S Kennedy, MD
Principal Investigator
North County Oncology
Oceanside California, 92056, United States More Info
Warren S Paroly, MD
Contact
Warren S Paroly, MD
Principal Investigator
Ventura County Hematology Oncology Specialists
Oxnard California, 93030, United States More Info
Rosemary E McIntyre, MD,PharmD
Contact
Rosemary E McIntyre, MD,PharmD
Principal Investigator
Cancer and Blood Institute Medical Group
Rancho Mirage California, 92270, United States More Info
Robert H Lemon, MD
Contact
Robert H Lemon, MD
Principal Investigator
St. Teresa Comprehensive Cancer Center
Stockton California, 95207, United States More Info
Neelesh S Bangalore, MD, PhD
Contact
Neelesh S Bangalore, MD, PhD
Principal Investigator
Medical Group of North County
Vista California, 92081, United States More Info
Alberto Bessudo, MD
Contact
Alberto Bessudo, MD
Principal Investigator
The Oncology Clinic, PC
Colorado Springs Colorado, 80907, United States More Info
David Headley, DO
Contact
David Headley, DO
Principal Investigator
Mile High Oncology
Denver Colorado, 80210, United States More Info
David Schrier, MD, DO
Contact
David Schrier, MD, DO
Principal Investigator
Palm Beach Institute of Hematology and Oncology
Boynton Beach Florida, 33435, United States More Info
Eyal Meiri, MD
Contact
Eyal Meiri, MD
Principal Investigator
Integrated Community Oncology Network
Jacksonville Florida, 32256, United States More Info
Medhi M Moezi, MD
Contact
Medhi M Moezi, MD
Principal Investigator
Osceola Cancer Center
Kissimmee Florida, 34741, United States More Info
Jorge G Otoya, MD
Contact
Jorge G Otoya, MD
Principal Investigator
Pasco Hernando Oncology Associates, PA
New Port Richey Florida, 34642, United States More Info
K.S. Kumar, MD
Contact
K.S. Kumar, MD
Principal Investigator
Pasco Pinellas Cancer Center
New Port Richey Florida, 34652, United States More Info
Roberto Arevalo-Araujo, MD,PharmD,PA
Contact
Roberto Arevalo-Araujo, MD,PharmD,PA
Principal Investigator
Augusta Oncology Associates, PC
Augusta Georgia, 30901, United States More Info
Mark R Keaton, MD
Contact
Mark R Keaton, MD
Principal Investigator
Spalding Oncology Services
Griffin Georgia, 30224, United States More Info
Rao Moravineni, MD
Contact
Rao Moravineni, MD
Principal Investigator
St Luke's Mountain States Tumor Institute
Boise Idaho, 83712, United States More Info
Theodore Walters, MD
Contact
Theodore Walters, MD
Principal Investigator
Oncology Hematology Assoc. of Northern Illinois
Gurnee Illinois, 60031, United States More Info
Nilesh D Mehta, MD, FACP
Contact
Nilesh D Mehta, MD, FACP
Principal Investigator
Indiana Oncology Hematology Consultants
Indianapolis Indiana, 46202, United States More Info
Maureen Cooper, MD
Contact
Maureen Cooper, MD
Principal Investigator
Arnett Cancer Care
Lafayette Indiana, 47904, United States More Info
Thomas I Jones, MD
Contact
Thomas I Jones, MD
Principal Investigator
Cancer Care Center
New Albany Indiana, 47150, United States More Info
Naveed Chowhan, MD
Contact
Naveed Chowhan, MD
Principal Investigator
Kentucky Cancer Clinic
Hazard Kentucky, 41701, United States More Info
Hassan Ghazal, MD
Contact
Hassan Ghazal, MD
Principal Investigator
Greater Baltimore Medical Center
Baltimore Maryland, 21204, United States More Info
Madhu Chaudhry, MD, MBBS
Contact
Madhu Chaudry, MD, MBBS
Principal Investigator
Chesapeake Oncology Hematology Associates
Baltimore Maryland, 21225, United States More Info
Yudhishtra Markan, MD
Contact
Yudhishtra Markan, MD
Principal Investigator
Auerbach Hematology Oncology Associates, Inc.
Baltimore Maryland, 21237, United States More Info
Michael Auerbach, MD, PharmD,FACP
Contact
Michael Auerbach, MD, PharmD,FACP
Principal Investigator
Genesee Cancer & Blood Disease Treatment Center, PC
Flint Michigan, 48503, United States More Info
Rizwan Danish, MD, FACP
Contact
Rizwan Danish, MD, FACP
Principal Investigator
West Michigan Regional Cancer & Blood Center
Freesoil Michigan, 49411, United States More Info
Ahmed S Behairy, MD
Contact
Ahmed S Behairy, MD
Principal Investigator
Spectrum Health Hospitals
Grand Rapids Michigan, 49503, United States More Info
Timothy O'Rourke, MD
Contact
Timothy O'Rourke, MD
Principal Investigator
Branson Oncology Clinic
Branson Missouri, 65616, United States More Info
Pairote Jaroonwanichkul, MD
Contact
Pairote Jaroonwanichkul, MD
Principal Investigator
St. Louis Hematology Oncology Specialists, Inc.
St. Louis Missouri, 63117, United States More Info
Alvin Schergen, MD, PharmD,FACP
Contact
Alvin Schergen, MD, PharmD,FACP
Principal Investigator
Sierra Nevada Oncology Care
Carson City Nevada, 89703, United States More Info
Jorge Perez-Cardona, MD
Contact
Jorge Perez-Cardona, MD
Principal Investigator
Nevada Cancer Center
Las Vegas Nevada, 89109, United States More Info
M. Nafees Nagy, MD
Contact
M. Nafees Nagy, MD
Principal Investigator
The Center for Cancer and Hematologic Disease
Cherry Hill New Jersey, 08003, United States More Info
Stephen Zrada, MD
Contact
Stephen Zrada, MD
Principal Investigator
Ellioth Fishkin, MD
Elizabeth New Jersey, 07201, United States More Info
Ellioth Fishkin, MD
Contact
Ellioth Fishkin, MD
Principal Investigator
Westchester Hematology Oncology Associates
Mount Kisco New York, 10549, United States More Info
Gino Bottino, MD
Contact
Gino Bottino, MD
Principal Investigator
Mid Dakota Clinic/Odyssey Research
Bismarck North Dakota, 58501, United States More Info
Bipinkumar R Amin, MD
Contact
Bipinkumar R Amin, MD
Principal Investigator
Summa Health System Hospitals
Akron Ohio, 44304, United States More Info
R. Douglas Trochelman, MD
Contact
R. Douglas Trochelman, MD
Principal Investigator
Nashat Y. Gabrail, MD, Inc.
Canton Ohio, 44718, United States More Info
Nashat Y Gabrail, MD
Contact
Nashat Y Gabrail, MD
Principal Investigator
Sambandam and Joseph Associates, Inc
Cranston Rhode Island, 02920, United States More Info
Plakyil J Joseph, MD
Contact
Plakyil J Joseph, MD
Principal Investigator
Charleston Hematology Oncology, PA
Charleston South Carolina, 29403, United States More Info
George F Geils, Jr., MD
Contact
George F Geils, Jr., MD
Principal Investigator
South Carolina Oncology Associates
Columbia South Carolina, 29210, United States More Info
Neal P Christiansen, MD
Contact
Neal P Christiansen, MD
Principal Investigator
The Family Cancer Center
Collierville Tennessee, 38017, United States More Info
David Gravenor, MD
Contact
David Gravenor, MD
Principal Investigator
C. Michael Jones, MD, PC
Germantown Tennessee, 38138, United States More Info
C. Michael Jones, MD, PC
Contact
C. Michael Jones, MD, PC
Principal Investigator
JPS Center for Cancer Care
Fort Worth Texas, 76104, United States More Info
Debra M Prow, MD
Contact
Debra M Prow, MD
Principal Investigator
Cache Valley Cancer Treatment & Research Clinic, Inc.
Logan Utah, 84341, United States More Info
Ali Ben-Jacob, MD
Contact
Ali Ben-Jacob, MD
Principal Investigator
Cancer Outreach Associates, PC
Abingdon Virginia, 24211, United States More Info
Forrest Swan, MD
Contact
Forest Swan, MD
Principal Investigator
Virginia Oncology Care, PC
Richlands Virginia, 24641, United States More Info
Madhaven V Pillai, MD, PharmD,FACP
Contact
Madhaven V Pillai, MD, PharmD, FACP
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 4

Estimated Enrollment:

180

Study ID:

NCT00131313

Recruitment Status:

Unknown status

Sponsor:


East Valley Hematology and Oncology Medical Group

How clear is this clinincal trial information?

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