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

The recruitment status of this study is unknown because the information has not been verified recently.
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
Endpoint Classification: Safety/Efficacy Study
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
Genders Eligible for Study:   Both
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

Contacts
Contact: Tracy Latimer 720-917-7478 tracyl@pharmatech.com

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

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
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 30, 2014