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
Recruitment status was Recruiting
Sponsor:
East Valley Hematology and Oncology Medical Group
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
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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 |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131313
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Contacts
| Contact: Tracy Latimer | 720-917-7478 | tracyl@pharmatech.com |
Hide Study LocationsLocations
| 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 | |
| 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 | |
| Lalita Pandit, MD, Inc. | Recruiting |
| Fountain Valley, California, United States, 92708 | |
| Contact: Lalita Pandit, MD | |
| Principal Investigator: Lalita Pandit, MD | |
| 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 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 | |
| Pasco Hernando Oncology Associates, PA | Recruiting |
| New Port Richey, Florida, United States, 34642 | |
| Contact: K.S. Kumar, MD | |
| Principal Investigator: K.S. Kumar, MD | |
| 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 | |
| Auerbach Hematology Oncology Associates, Inc. | Recruiting |
| Baltimore, Maryland, United States, 21237 | |
| Contact: Michael Auerbach, MD, PharmD,FACP | |
| Principal Investigator: Michael Auerbach, MD, PharmD,FACP | |
| Greater Baltimore Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21204 | |
| Contact: Madhu Chaudhry, MD, MBBS | |
| Principal Investigator: Madhu Chaudry, MD, MBBS | |
| 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 Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Rituximab Pentostatin |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses 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 May 16, 2013