Recruiting

Nipent, Cytoxan, Rituxan

Sponsor:

East Valley Hematology and Oncology Medical Group

Code:

NCT00131313

Conditions

Chronic Lymphocytic Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nipent, Cytoxan, Rituxan

Study Details

Brief 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.

Conditions

Chronic Lymphocytic Leukemia

Study ID

NCT00131313

Start date

Jan, 2003

Status verified date

Aug, 2005

Completion date

Apr, 2009

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

180 participants

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Nipent, Cytoxan, Rituxan

Primary outcome measure

  • Efficacy response rate [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Tracy Latimer

720-917-7478tracyl@pharmatech.com

Locations

Northwest Alabama Cancer Center, PC

Recruiting

Muscle Shoals, Alabama, United States, 35661

Principal Investigator:

James Daugherty, MD

East Valley Hematology and Oncology Medical Group

Recruiting

Burbank, California, United States, 91505

Principal Investigator:

Raul R Mena, MD

Bay Area Cancer Research Group

Recruiting

Concord, California, United States, 94520

Principal Investigator:

Robert L Robles, MD

Lalita Pandit, MD, Inc.

Recruiting

Fountain Valley, California, United States, 92708

Principal Investigator:

Lalita Pandit, MD

Pacific Coast Hematology/Oncology Medical Group, Inc.

Recruiting

Fountain Valley, California, United States, 92708

Principal Investigator:

Glen R Justice, MD

Robert A. Moss, M.D. FACP, Inc.

Recruiting

Fountain Valley, California, United States, 92708

Principal Investigator:

Robert A Moss, MD, FACP

Metropolitan Hematology Oncology Medical Group

Recruiting

Los Angeles, California, United States, 90057

Principal Investigator:

Peter S Kennedy, MD

North County Oncology

Recruiting

Oceanside, California, United States, 92056

Principal Investigator:

Warren S Paroly, MD

Ventura County Hematology Oncology Specialists

Recruiting

Oxnard, California, United States, 93030

Principal Investigator:

Rosemary E McIntyre, MD,PharmD

Cancer and Blood Institute Medical Group

Recruiting

Rancho Mirage, California, United States, 92270

Principal Investigator:

Robert H Lemon, MD

St. Teresa Comprehensive Cancer Center

Recruiting

Stockton, California, United States, 95207

Principal Investigator:

Neelesh S Bangalore, MD, PhD

Medical Group of North County

Recruiting

Vista, California, United States, 92081

Principal Investigator:

Alberto Bessudo, MD

The Oncology Clinic, PC

Recruiting

Colorado Springs, Colorado, United States, 80907

Principal Investigator:

David Headley, DO

Mile High Oncology

Recruiting

Denver, Colorado, United States, 80210

Principal Investigator:

David Schrier, MD, DO

Palm Beach Institute of Hematology and Oncology

Recruiting

Boynton Beach, Florida, United States, 33435

Principal Investigator:

Eyal Meiri, MD

Integrated Community Oncology Network

Recruiting

Jacksonville, Florida, United States, 32256

Principal Investigator:

Medhi M Moezi, MD

Osceola Cancer Center

Recruiting

Kissimmee, Florida, United States, 34741

Principal Investigator:

Jorge G Otoya, MD

Pasco Hernando Oncology Associates, PA

Recruiting

New Port Richey, Florida, United States, 34642

Principal Investigator:

K.S. Kumar, MD

Pasco Pinellas Cancer Center

Recruiting

New Port Richey, Florida, United States, 34652

Principal Investigator:

Roberto Arevalo-Araujo, MD,PharmD,PA

Augusta Oncology Associates, PC

Recruiting

Augusta, Georgia, United States, 30901

Principal Investigator:

Mark R Keaton, MD

Spalding Oncology Services

Recruiting

Griffin, Georgia, United States, 30224

Principal Investigator:

Rao Moravineni, MD

St Luke's Mountain States Tumor Institute

Recruiting

Boise, Idaho, United States, 83712

Principal Investigator:

Theodore Walters, MD

Oncology Hematology Assoc. of Northern Illinois

Recruiting

Gurnee, Illinois, United States, 60031

Principal Investigator:

Nilesh D Mehta, MD, FACP

Indiana Oncology Hematology Consultants

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Maureen Cooper, MD

Arnett Cancer Care

Recruiting

Lafayette, Indiana, United States, 47904

Principal Investigator:

Thomas I Jones, MD

Cancer Care Center

Recruiting

New Albany, Indiana, United States, 47150

Principal Investigator:

Naveed Chowhan, MD

Kentucky Cancer Clinic

Recruiting

Hazard, Kentucky, United States, 41701

Principal Investigator:

Hassan Ghazal, MD

Greater Baltimore Medical Center

Recruiting

Baltimore, Maryland, United States, 21204

Principal Investigator:

Madhu Chaudry, MD, MBBS

Chesapeake Oncology Hematology Associates

Recruiting

Baltimore, Maryland, United States, 21225

Principal Investigator:

Yudhishtra Markan, MD

Auerbach Hematology Oncology Associates, Inc.

Recruiting

Baltimore, Maryland, United States, 21237

Principal Investigator:

Michael Auerbach, MD, PharmD,FACP

Genesee Cancer & Blood Disease Treatment Center, PC

Recruiting

Flint, Michigan, United States, 48503

Principal Investigator:

Rizwan Danish, MD, FACP

West Michigan Regional Cancer & Blood Center

Recruiting

Freesoil, Michigan, United States, 49411

Principal Investigator:

Ahmed S Behairy, MD

Spectrum Health Hospitals

Recruiting

Grand Rapids, Michigan, United States, 49503

Principal Investigator:

Timothy O'Rourke, MD

Branson Oncology Clinic

Recruiting

Branson, Missouri, United States, 65616

Principal Investigator:

Pairote Jaroonwanichkul, MD

St. Louis Hematology Oncology Specialists, Inc.

Recruiting

St. Louis, Missouri, United States, 63117

Principal Investigator:

Alvin Schergen, MD, PharmD,FACP

Sierra Nevada Oncology Care

Recruiting

Carson City, Nevada, United States, 89703

Principal Investigator:

Jorge Perez-Cardona, MD

Nevada Cancer Center

Recruiting

Las Vegas, Nevada, United States, 89109

Principal Investigator:

M. Nafees Nagy, MD

The Center for Cancer and Hematologic Disease

Recruiting

Cherry Hill, New Jersey, United States, 08003

Principal Investigator:

Stephen Zrada, MD

Ellioth Fishkin, MD

Recruiting

Elizabeth, New Jersey, United States, 07201

Principal Investigator:

Ellioth Fishkin, MD

Westchester Hematology Oncology Associates

Recruiting

Mount Kisco, New York, United States, 10549

Principal Investigator:

Gino Bottino, MD

Mid Dakota Clinic/Odyssey Research

Recruiting

Bismarck, North Dakota, United States, 58501

Principal Investigator:

Bipinkumar R Amin, MD

Summa Health System Hospitals

Recruiting

Akron, Ohio, United States, 44304

Principal Investigator:

R. Douglas Trochelman, MD

Nashat Y. Gabrail, MD, Inc.

Recruiting

Canton, Ohio, United States, 44718

Principal Investigator:

Nashat Y Gabrail, MD

Sambandam and Joseph Associates, Inc

Recruiting

Cranston, Rhode Island, United States, 02920

Principal Investigator:

Plakyil J Joseph, MD

Charleston Hematology Oncology, PA

Recruiting

Charleston, South Carolina, United States, 29403

Principal Investigator:

George F Geils, Jr., MD

South Carolina Oncology Associates

Recruiting

Columbia, South Carolina, United States, 29210

Principal Investigator:

Neal P Christiansen, MD

The Family Cancer Center

Recruiting

Collierville, Tennessee, United States, 38017

Principal Investigator:

David Gravenor, MD

C. Michael Jones, MD, PC

Recruiting

Germantown, Tennessee, United States, 38138

Principal Investigator:

C. Michael Jones, MD, PC

JPS Center for Cancer Care

Recruiting

Fort Worth, Texas, United States, 76104

Principal Investigator:

Debra M Prow, MD

Cache Valley Cancer Treatment & Research Clinic, Inc.

Recruiting

Logan, Utah, United States, 84341

Principal Investigator:

Ali Ben-Jacob, MD

Cancer Outreach Associates, PC

Recruiting

Abingdon, Virginia, United States, 24211

Principal Investigator:

Forest Swan, MD

Virginia Oncology Care, PC

Recruiting

Richlands, Virginia, United States, 24641

Principal Investigator:

Madhaven V Pillai, MD, PharmD, FACP

More Information

Sponsor

East Valley Hematology and Oncology Medical Group

Last update posted

Aug 18, 2005

Last verified

Aug, 2005

Keywords

  • Leukemia
  • Cancer
  • Nipent
  • Rituxan
  • Cytoxan

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by East Valley Hematology and Oncology Medical Group on 2005-08-18.