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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2005 by East Valley Hematology and Oncology Medical Group.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
Mena, Raul, M.D.
Pharmatech Oncology
Astex Pharmaceuticals
Information provided by:
East Valley Hematology and Oncology Medical Group
ClinicalTrials.gov Identifier:
NCT00131313
First received: August 16, 2005
Last updated: August 17, 2005
Last verified: August 2005
  Purpose
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.

Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Nipent, Cytoxan, Rituxan
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia.

Resource links provided by NLM:


Further study details as provided by East Valley Hematology and Oncology Medical Group:

Primary Outcome Measures:
  • Efficacy response rate

Secondary Outcome Measures:
  • Time to progression
  • Time to treatment failure
  • Toxicity
  • Incidence and severity of adverse events

Estimated Enrollment: 180
Study Start Date: January 2003
Estimated Study Completion Date: April 2009
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131313

  Hide Study Locations
Locations
United States, Alabama
Northwest Alabama Cancer Center, PC
Muscle Shoals, Alabama, United States, 35661
United States, California
East Valley Hematology and Oncology Medical Group
Burbank, California, United States, 91505
Bay Area Cancer Research Group
Concord, California, United States, 94520
Lalita Pandit, MD, Inc.
Fountain Valley, California, United States, 92708
Pacific Coast Hematology/Oncology Medical Group, Inc.
Fountain Valley, California, United States, 92708
Robert A. Moss, M.D. FACP, Inc.
Fountain Valley, California, United States, 92708
Metropolitan Hematology Oncology Medical Group
Los Angeles, California, United States, 90057
North County Oncology
Oceanside, California, United States, 92056
Ventura County Hematology Oncology Specialists
Oxnard, California, United States, 93030
Cancer and Blood Institute Medical Group
Rancho Mirage, California, United States, 92270
St. Teresa Comprehensive Cancer Center
Stockton, California, United States, 95207
Medical Group of North County
Vista, California, United States, 92081
United States, Colorado
The Oncology Clinic, PC
Colorado Springs, Colorado, United States, 80907
Mile High Oncology
Denver, Colorado, United States, 80210
United States, Florida
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, United States, 33435
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
Osceola Cancer Center
Kissimmee, Florida, United States, 34741
Pasco Hernando Oncology Associates, PA
New Port Richey, Florida, United States, 34642
Pasco Pinellas Cancer Center
New Port Richey, Florida, United States, 34652
United States, Georgia
Augusta Oncology Associates, PC
Augusta, Georgia, United States, 30901
Spalding Oncology Services
Griffin, Georgia, United States, 30224
United States, Idaho
St Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
United States, Illinois
Oncology Hematology Assoc. of Northern Illinois
Gurnee, Illinois, United States, 60031
United States, Indiana
Indiana Oncology Hematology Consultants
Indianapolis, Indiana, United States, 46202
Arnett Cancer Care
Lafayette, Indiana, United States, 47904
Cancer Care Center
New Albany, Indiana, United States, 47150
United States, Kentucky
Kentucky Cancer Clinic
Hazard, Kentucky, United States, 41701
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Chesapeake Oncology Hematology Associates
Baltimore, Maryland, United States, 21225
Auerbach Hematology Oncology Associates, Inc.
Baltimore, Maryland, United States, 21237
United States, Michigan
Genesee Cancer & Blood Disease Treatment Center, PC
Flint, Michigan, United States, 48503
West Michigan Regional Cancer & Blood Center
Freesoil, Michigan, United States, 49411
Spectrum Health Hospitals
Grand Rapids, Michigan, United States, 49503
United States, Missouri
Branson Oncology Clinic
Branson, Missouri, United States, 65616
St. Louis Hematology Oncology Specialists, Inc.
St. Louis, Missouri, United States, 63117
United States, Nevada
Sierra Nevada Oncology Care
Carson City, Nevada, United States, 89703
Nevada Cancer Center
Las Vegas, Nevada, United States, 89109
United States, New Jersey
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States, 08003
Ellioth Fishkin, MD
Elizabeth, New Jersey, United States, 07201
United States, New York
Westchester Hematology Oncology Associates
Mount Kisco, New York, United States, 10549
United States, North Dakota
Mid Dakota Clinic/Odyssey Research
Bismarck, North Dakota, United States, 58501
United States, Ohio
Summa Health System Hospitals
Akron, Ohio, United States, 44304
Nashat Y. Gabrail, MD, Inc.
Canton, Ohio, United States, 44718
United States, Rhode Island
Sambandam and Joseph Associates, Inc
Cranston, Rhode Island, United States, 02920
United States, South Carolina
Charleston Hematology Oncology, PA
Charleston, South Carolina, United States, 29403
South Carolina Oncology Associates
Columbia, South Carolina, United States, 29210
United States, Tennessee
The Family Cancer Center
Collierville, Tennessee, United States, 38017
C. Michael Jones, MD, PC
Germantown, Tennessee, United States, 38138
United States, Texas
JPS Center for Cancer Care
Fort Worth, Texas, United States, 76104
United States, Utah
Cache Valley Cancer Treatment & Research Clinic, Inc.
Logan, Utah, United States, 84341
United States, Virginia
Cancer Outreach Associates, PC
Abingdon, Virginia, United States, 24211
Virginia Oncology Care, PC
Richlands, Virginia, United States, 24641
Sponsors and Collaborators
East Valley Hematology and Oncology Medical Group
Mena, Raul, M.D.
Pharmatech Oncology
Astex Pharmaceuticals
Investigators
Principal Investigator: Raul Mena, MD East Valley Hematology and Oncology Group
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00131313     History of Changes
Other Study ID Numbers: POI-02818  NIP-02-005 
Study First Received: August 16, 2005
Last Updated: August 17, 2005

Keywords provided by East Valley Hematology and Oncology Medical Group:
Leukemia
Cancer
Nipent
Rituxan
Cytoxan

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Cyclophosphamide
Rituximab
Pentostatin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Adenosine Deaminase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 17, 2017