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

August 17, 2005 updated by: East Valley Hematology and Oncology Medical Group

A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy response rate

Secondary Outcome Measures

Outcome Measure
Toxicity
Time to progression
Time to treatment failure
Incidence and severity of adverse events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Valley Hematology and Oncology Medical Group

Collaborators

Astex Pharmaceuticals, Inc.
Pharmatech Oncology
Mena, Raul, M.D.

Investigators

  • Principal Investigator: Raul Mena, MD, East Valley Hematology and Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion

April 1, 2009

Study Registration Dates

First Submitted

August 16, 2005

First Submitted That Met QC Criteria

August 17, 2005

First Posted (Estimate)

August 18, 2005

Study Record Updates

Last Update Posted (Estimate)

August 18, 2005

Last Update Submitted That Met QC Criteria

August 17, 2005

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POI-02818
  • NIP-02-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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