A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia.
18 Years
N/A
Both
Chronic Lymphocytic Leukemia
Trial Information
A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia.
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy response rate
Principal Investigator
Raul Mena, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
East Valley Hematology and Oncology Group
Authority:
United States: Institutional Review Board
Study ID:
POI-02818
NCT ID:
NCT00131313
Start Date:
January 2003
Completion Date:
April 2009
Related Keywords:
- Chronic Lymphocytic Leukemia
- Leukemia
- Cancer
- Nipent
- Rituxan
- Cytoxan
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
Name | Location |
|---|---|
| Nevada Cancer Center | Las Vegas, Nevada 89109 |
| Cancer Care Center | New Albany, Indiana 47150 |
| Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
| Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
| South Carolina Oncology Associates | Columbia, South Carolina 29201 |
| Osceola Cancer Center | Kissimmee, Florida 34741 |
| The Center for Cancer and Hematologic Disease | Cherry Hill, New Jersey 08003 |
| Medical Group of North County | Vista, California 92083 |
| Pasco Pinellas Cancer Center | New Port Richey, Florida 34652 |
| Bay Area Cancer Research Group | Concord, California 94520 |
| Pacific Coast Hematology/Oncology Medical Group, Inc. | Fountain Valley, California 92708 |
| Nashat Y. Gabrail, MD, Inc. | Canton, Ohio 44718 |
| Arnett Cancer Care | Lafayette, Indiana 47904 |
| Kentucky Cancer Clinic | Pikeville, Kentucky 41501 |
| Mile High Oncology | Denver, Colorado 80210 |
| Indiana Oncology Hematology Consultants | Indianapolis, Indiana 46202 |
| The Family Cancer Center | Collierville, Tennessee 38017 |
| Spalding Oncology Services | Griffin, Georgia 30224 |
| Charleston Hematology Oncology, PA | Charleston, South Carolina 29403 |
| Cancer and Blood Institute Medical Group | Rancho Mirage, California 92270 |
| West Michigan Regional Cancer & Blood Center | Free Soil, Michigan 49411 |
| Westchester Hematology Oncology Associates | Mount Kisco, New York 10549 |
| Ventura County Hematology Oncology Specialists | Oxnard, California 93030 |
| Palm Beach Institute of Hematology and Oncology | Boynton Beach, Florida 33435 |
| JPS Center for Cancer Care | Fort Worth, Texas 76104 |
| Sierra Nevada Oncology Care | Carson City, Nevada 89703 |
| Cancer Outreach Associates, PC | Abingdon, Virginia 24211 |
| Northwest Alabama Cancer Center, PC | Florence, Alabama 35630 |
| East Valley Hematology and Oncology Medical Group | Burbank, California 91505 |
| Lalita Pandit, MD, Inc. | Fountain Valley, California 92708 |
| Robert A. Moss, M.D. FACP, Inc. | Fountain Valley, California 92708 |
| Metropolitan Hematology Oncology Medical Group | Los Angeles, California 90057 |
| North County Oncology | Oceanside, California 92056 |
| St. Teresa Comprehensive Cancer Center | Stockton, California 95207 |
| The Oncology Clinic, PC | Colorado Springs, Colorado 80907 |
| Pasco Hernando Oncology Associates, PA | New Port Richey, Florida 34642 |
| Augusta Oncology Associates, PC | Augusta, Georgia 30901 |
| St Luke's Mountain States Tumor Institute | Boise, Idaho 83712 |
| Oncology Hematology Assoc. of Northern Illinois | Gurnee, Illinois 60031 |
| Auerbach Hematology Oncology Associates, Inc. | Baltimore, Maryland 21237 |
| Chesapeake Oncology Hematology Associates | Baltimore, Maryland 21225 |
| Genesee Cancer & Blood Disease Treatment Center, PC | Flint, Michigan 48503 |
| Spectrum Health Hospitals | Grand Rapids, Michigan 49503 |
| Branson Oncology Clinic | Branson, Missouri 65616 |
| St. Louis Hematology Oncology Specialists, Inc. | St. Louis, Missouri 63117 |
| Ellioth Fishkin, MD | Elizabeth, New Jersey 07201 |
| Mid Dakota Clinic/Odyssey Research | Bismarck, North Dakota 58501 |
| Summa Health System Hospitals | Akron, Ohio 44304 |
| Sambandam and Joseph Associates, Inc | Cranston, Rhode Island 02920 |
| C. Michael Jones, MD, PC | Germantown, Tennessee 38138 |
| Cache Valley Cancer Treatment & Research Clinic, Inc. | Logan, Utah 84341 |
| Virginia Oncology Care, PC | Richlands, Virginia 24641 |
