Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.
Study Details
Study Description
Brief 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). 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 or Disease | Intervention/Treatment | Phase |
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|
Phase 4 |
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 Design
Outcome Measures
Primary Outcome Measures
- Efficacy response rate []
Secondary Outcome Measures
- Time to progression []
- Time to treatment failure []
- Toxicity []
- Incidence and severity of adverse events []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Stage II, III or IV Chronic Lymphocytic Leukemia
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Disease requires chemotherapeutic treatment
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CT or MRI scan confirming measurable tumor size
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Documentation of CD markers
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Up to one prior treatment regimen
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Expected survival greater than 6 months
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ECOG performance status of 0-2
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Adequate renal, bone marrow and liver functions
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Negative pregnancy test (females of childbearing potential)
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Must agree to use acceptable birth control, if fertile
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Must complete Informed Consent
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No heart disease and must have adequate cardiac function
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Must test negative for viral Hepatitis B and C
Exclusion Criteria:
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More than one prior treatment for Chronic Lymphocytic Leukemia
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Known sensitivity to Nipent, Rituxan or Cytoxan or any component of these drugs
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Known HIV or AIDS illness
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Thyroid disease requiring medication
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History of any malignancy that could affect the diagnosis or assessment of the study treatment
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Pregnancy or breast feeding
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Evidence of Hepatitis B or C infection
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Inability to comply with the requirements of the study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Northwest Alabama Cancer Center, PC | Muscle Shoals | Alabama | United States | 35661 |
2 | East Valley Hematology and Oncology Medical Group | Burbank | California | United States | 91505 |
3 | Bay Area Cancer Research Group | Concord | California | United States | 94520 |
4 | Lalita Pandit, MD, Inc. | Fountain Valley | California | United States | 92708 |
5 | Pacific Coast Hematology/Oncology Medical Group, Inc. | Fountain Valley | California | United States | 92708 |
6 | Robert A. Moss, M.D. FACP, Inc. | Fountain Valley | California | United States | 92708 |
7 | Metropolitan Hematology Oncology Medical Group | Los Angeles | California | United States | 90057 |
8 | North County Oncology | Oceanside | California | United States | 92056 |
9 | Ventura County Hematology Oncology Specialists | Oxnard | California | United States | 93030 |
10 | Cancer and Blood Institute Medical Group | Rancho Mirage | California | United States | 92270 |
11 | St. Teresa Comprehensive Cancer Center | Stockton | California | United States | 95207 |
12 | Medical Group of North County | Vista | California | United States | 92081 |
13 | The Oncology Clinic, PC | Colorado Springs | Colorado | United States | 80907 |
14 | Mile High Oncology | Denver | Colorado | United States | 80210 |
15 | Palm Beach Institute of Hematology and Oncology | Boynton Beach | Florida | United States | 33435 |
16 | Integrated Community Oncology Network | Jacksonville | Florida | United States | 32256 |
17 | Osceola Cancer Center | Kissimmee | Florida | United States | 34741 |
18 | Pasco Hernando Oncology Associates, PA | New Port Richey | Florida | United States | 34642 |
19 | Pasco Pinellas Cancer Center | New Port Richey | Florida | United States | 34652 |
20 | Augusta Oncology Associates, PC | Augusta | Georgia | United States | 30901 |
21 | Spalding Oncology Services | Griffin | Georgia | United States | 30224 |
22 | St Luke's Mountain States Tumor Institute | Boise | Idaho | United States | 83712 |
23 | Oncology Hematology Assoc. of Northern Illinois | Gurnee | Illinois | United States | 60031 |
24 | Indiana Oncology Hematology Consultants | Indianapolis | Indiana | United States | 46202 |
25 | Arnett Cancer Care | Lafayette | Indiana | United States | 47904 |
26 | Cancer Care Center | New Albany | Indiana | United States | 47150 |
27 | Kentucky Cancer Clinic | Hazard | Kentucky | United States | 41701 |
28 | Greater Baltimore Medical Center | Baltimore | Maryland | United States | 21204 |
29 | Chesapeake Oncology Hematology Associates | Baltimore | Maryland | United States | 21225 |
30 | Auerbach Hematology Oncology Associates, Inc. | Baltimore | Maryland | United States | 21237 |
31 | Genesee Cancer & Blood Disease Treatment Center, PC | Flint | Michigan | United States | 48503 |
32 | West Michigan Regional Cancer & Blood Center | Freesoil | Michigan | United States | 49411 |
33 | Spectrum Health Hospitals | Grand Rapids | Michigan | United States | 49503 |
34 | Branson Oncology Clinic | Branson | Missouri | United States | 65616 |
35 | St. Louis Hematology Oncology Specialists, Inc. | St. Louis | Missouri | United States | 63117 |
36 | Sierra Nevada Oncology Care | Carson City | Nevada | United States | 89703 |
37 | Nevada Cancer Center | Las Vegas | Nevada | United States | 89109 |
38 | The Center for Cancer and Hematologic Disease | Cherry Hill | New Jersey | United States | 08003 |
39 | Ellioth Fishkin, MD | Elizabeth | New Jersey | United States | 07201 |
40 | Westchester Hematology Oncology Associates | Mount Kisco | New York | United States | 10549 |
41 | Mid Dakota Clinic/Odyssey Research | Bismarck | North Dakota | United States | 58501 |
42 | Summa Health System Hospitals | Akron | Ohio | United States | 44304 |
43 | Nashat Y. Gabrail, MD, Inc. | Canton | Ohio | United States | 44718 |
44 | Sambandam and Joseph Associates, Inc | Cranston | Rhode Island | United States | 02920 |
45 | Charleston Hematology Oncology, PA | Charleston | South Carolina | United States | 29403 |
46 | South Carolina Oncology Associates | Columbia | South Carolina | United States | 29210 |
47 | The Family Cancer Center | Collierville | Tennessee | United States | 38017 |
48 | C. Michael Jones, MD, PC | Germantown | Tennessee | United States | 38138 |
49 | JPS Center for Cancer Care | Fort Worth | Texas | United States | 76104 |
50 | Cache Valley Cancer Treatment & Research Clinic, Inc. | Logan | Utah | United States | 84341 |
51 | Cancer Outreach Associates, PC | Abingdon | Virginia | United States | 24211 |
52 | 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, Inc.
Investigators
- Principal Investigator: Raul Mena, MD, East Valley Hematology and Oncology Group
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- POI-02818
- NIP-02-005