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Chronic Lymphocytic LeukemiaPhase 4NCT00131313

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

A Phase 4 study testing Nipent, Cytoxan, Rituxan in people with Chronic Lymphocytic Leukemia, run by East Valley Hematology and Oncology Medical Group at 52 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Nipent, Cytoxan, Rituxan
How many people
180 participants
Where
52 sitesUnited States
Study dates
Jan 2003to Apr 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

United States52 sites, 52 recruiting
  • Cancer Outreach Associates, PC

    Abingdon, Virginia, 24211

    Forrest Swan, MD

    Forest Swan, MD

    Recruiting
  • Summa Health System Hospitals

    Akron, Ohio, 44304

    R. Douglas Trochelman, MD

    R. Douglas Trochelman, MD

    Recruiting
  • Augusta Oncology Associates, PC

    Augusta, Georgia, 30901

    Mark R Keaton, MD

    Mark R Keaton, MD

    Recruiting
  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

    Madhu Chaudhry, MD, MBBS

    Madhu Chaudry, MD, MBBS

    Recruiting
  • Chesapeake Oncology Hematology Associates

    Baltimore, Maryland, 21225

    Yudhishtra Markan, MD

    Yudhishtra Markan, MD

    Recruiting
  • Auerbach Hematology Oncology Associates, Inc.

    Baltimore, Maryland, 21237

    Michael Auerbach, MD, PharmD,FACP

    Michael Auerbach, MD, PharmD,FACP

    Recruiting
  • Mid Dakota Clinic/Odyssey Research

    Bismarck, North Dakota, 58501

    Bipinkumar R Amin, MD

    Bipinkumar R Amin, MD

    Recruiting
  • St Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

    Theodore Walters, MD

    Theodore Walters, MD

    Recruiting
  • Palm Beach Institute of Hematology and Oncology

    Boynton Beach, Florida, 33435

    Eyal Meiri, MD

    Eyal Meiri, MD

    Recruiting
  • Branson Oncology Clinic

    Branson, Missouri, 65616

    Pairote Jaroonwanichkul, MD

    Pairote Jaroonwanichkul, MD

    Recruiting
  • East Valley Hematology and Oncology Medical Group

    Burbank, California, 91505

    Raul R Mena, MD

    Raul R Mena, MD

    Recruiting
  • Nashat Y. Gabrail, MD, Inc.

    Canton, Ohio, 44718

    Nashat Y Gabrail, MD

    Nashat Y Gabrail, MD

    Recruiting
  • Sierra Nevada Oncology Care

    Carson City, Nevada, 89703

    Jorge Perez-Cardona, MD

    Jorge Perez-Cardona, MD

    Recruiting
  • Charleston Hematology Oncology, PA

    Charleston, South Carolina, 29403

    George F Geils, Jr., MD

    George F Geils, Jr., MD

    Recruiting
  • The Center for Cancer and Hematologic Disease

    Cherry Hill, New Jersey, 08003

    Stephen Zrada, MD

    Stephen Zrada, MD

    Recruiting
  • The Family Cancer Center

    Collierville, Tennessee, 38017

    David Gravenor, MD

    David Gravenor, MD

    Recruiting
  • The Oncology Clinic, PC

    Colorado Springs, Colorado, 80907

    David Headley, DO

    David Headley, DO

    Recruiting
  • South Carolina Oncology Associates

    Columbia, South Carolina, 29210

    Neal P Christiansen, MD

    Neal P Christiansen, MD

    Recruiting
  • Bay Area Cancer Research Group

    Concord, California, 94520

    Robert L Robles, MD

    Robert L Robles, MD

    Recruiting
  • Sambandam and Joseph Associates, Inc

    Cranston, Rhode Island, 02920

    Plakyil J Joseph, MD

    Plakyil J Joseph, MD

    Recruiting
  • Mile High Oncology

    Denver, Colorado, 80210

    David Schrier, MD, DO

    David Schrier, MD, DO

    Recruiting
  • Ellioth Fishkin, MD

    Elizabeth, New Jersey, 07201

    Ellioth Fishkin, MD

    Ellioth Fishkin, MD

    Recruiting
  • Genesee Cancer & Blood Disease Treatment Center, PC

    Flint, Michigan, 48503

    Rizwan Danish, MD, FACP

    Rizwan Danish, MD, FACP

    Recruiting
  • JPS Center for Cancer Care

    Fort Worth, Texas, 76104

    Debra M Prow, MD

    Debra M Prow, MD

    Recruiting
  • Lalita Pandit, MD, Inc.

    Fountain Valley, California, 92708

    Lalita Pandit, MD

    Lalita Pandit, MD

    Recruiting
  • Pacific Coast Hematology/Oncology Medical Group, Inc.

    Fountain Valley, California, 92708

    Glen R Justice, MD

    Glen R Justice, MD

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

    Fountain Valley, California, 92708

    Robert A Moss, MD, FACP

    Robert A Moss, MD, FACP

    Recruiting
  • West Michigan Regional Cancer & Blood Center

    Free Soil, Michigan, 49411

    Ahmed S Behairy, MD

    Ahmed S Behairy, MD

    Recruiting
  • C. Michael Jones, MD, PC

    Germantown, Tennessee, 38138

    C. Michael Jones, MD, PC

    C. Michael Jones, MD, PC

    Recruiting
  • Spectrum Health Hospitals

    Grand Rapids, Michigan, 49503

    Timothy O'Rourke, MD

    Timothy O'Rourke, MD

    Recruiting
  • Spalding Oncology Services

    Griffin, Georgia, 30224

    Rao Moravineni, MD

    Rao Moravineni, MD

    Recruiting
  • Oncology Hematology Assoc. of Northern Illinois

    Gurnee, Illinois, 60031

    Nilesh D Mehta, MD, FACP

    Nilesh D Mehta, MD, FACP

    Recruiting
  • Kentucky Cancer Clinic

    Hazard, Kentucky, 41701

    Hassan Ghazal, MD

    Hassan Ghazal, MD

    Recruiting
  • Indiana Oncology Hematology Consultants

    Indianapolis, Indiana, 46202

    Maureen Cooper, MD

    Maureen Cooper, MD

    Recruiting
  • Integrated Community Oncology Network

    Jacksonville, Florida, 32256

    Medhi M Moezi, MD

    Medhi M Moezi, MD

    Recruiting
  • Osceola Cancer Center

    Kissimmee, Florida, 34741

    Jorge G Otoya, MD

    Jorge G Otoya, MD

    Recruiting
  • Arnett Cancer Care

    Lafayette, Indiana, 47904

    Thomas I Jones, MD

    Thomas I Jones, MD

    Recruiting
  • Nevada Cancer Center

    Las Vegas, Nevada, 89109

    M. Nafees Nagy, MD

    M. Nafees Nagy, MD

    Recruiting
  • Cache Valley Cancer Treatment & Research Clinic, Inc.

    Logan, Utah, 84341

    Ali Ben-Jacob, MD

    Ali Ben-Jacob, MD

    Recruiting
  • Metropolitan Hematology Oncology Medical Group

    Los Angeles, California, 90057

    Peter S Kennedy, MD

    Peter S Kennedy, MD

    Recruiting
  • Westchester Hematology Oncology Associates

    Mount Kisco, New York, 10549

    Gino Bottino, MD

    Gino Bottino, MD

    Recruiting
  • Northwest Alabama Cancer Center, PC

    Muscle Shoals, Alabama, 35661

    James Daugherty, MD

    James Daugherty, MD

    Recruiting
  • Cancer Care Center

    New Albany, Indiana, 47150

    Naveed Chowhan, MD

    Naveed Chowhan, MD

    Recruiting
  • Pasco Hernando Oncology Associates, PA

    New Port Richey, Florida, 34642

    K.S. Kumar, MD

    K.S. Kumar, MD

    Recruiting
  • Pasco Pinellas Cancer Center

    New Port Richey, Florida, 34652

    Roberto Arevalo-Araujo, MD,PharmD,PA

    Roberto Arevalo-Araujo, MD,PharmD,PA

    Recruiting
  • North County Oncology

    Oceanside, California, 92056

    Warren S Paroly, MD

    Warren S Paroly, MD

    Recruiting
  • Ventura County Hematology Oncology Specialists

    Oxnard, California, 93030

    Rosemary E McIntyre, MD,PharmD

    Rosemary E McIntyre, MD,PharmD

    Recruiting
  • Cancer and Blood Institute Medical Group

    Rancho Mirage, California, 92270

    Robert H Lemon, MD

    Robert H Lemon, MD

    Recruiting
  • Virginia Oncology Care, PC

    Richlands, Virginia, 24641

    Madhaven V Pillai, MD, PharmD,FACP

    Madhaven V Pillai, MD, PharmD, FACP

    Recruiting
  • St. Louis Hematology Oncology Specialists, Inc.

    St Louis, Missouri, 63117

    Alvin Schergen, MD, PharmD,FACP

    Alvin Schergen, MD, PharmD,FACP

    Recruiting
  • St. Teresa Comprehensive Cancer Center

    Stockton, California, 95207

    Neelesh S Bangalore, MD, PhD

    Neelesh S Bangalore, MD, PhD

    Recruiting
  • Medical Group of North County

    Vista, California, 92081

    Alberto Bessudo, MD

    Alberto Bessudo, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Nipent, Cytoxan, Rituxan
Keywords
Leukemia, Cancer, Nipent, Rituxan, Cytoxan
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nipent, Cytoxan, RituxanDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy response rate

Secondary outcomes (4)
  1. Time to progression

  2. Time to treatment failure

  3. Toxicity

  4. Incidence and severity of adverse events

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2005 (estimated)
  2. Study startJan 2003
  3. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
180 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00131313
Sponsor's protocol ID
POI-02818
Other IDs
NIP-02-005
Status last verified
Aug 2005
First submitted
16 Aug 2005
Last updated
18 Aug 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nipent, Cytoxan, Rituxan in people with Chronic Lymphocytic Leukemia, run by East Valley Hematology and Oncology Medical Group at 52 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tracy Latimer (720-917-7478, tracyl@pharmatech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy response rate. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2005.

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