|
Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients with Progressive B-Cell Lymphocytic Leukemia Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients with Progressive B-Cell Lymphocytic Leukemia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients with Progressive B-Cell Lymphocytic Leukemia Clinical research trials and Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients with Progressive B-Cell Lymphocytic Leukemia healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients with Progressive B-Cell Lymphocytic Leukemia. Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients with Progressive B-Cell Lymphocytic Leukemia Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients with Progressive B-Cell Lymphocytic Leukemia clinical trial. Human subjects often receive the most effective healthcare possible for their Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients with Progressive B-Cell Lymphocytic Leukemia condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "E" Clinical Trials Conditions > Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients with Progressive B-Cell Lymphocytic Leukemia  Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients with Progressive B-Cell Lymphocytic Leukemia
Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients with Progressive B-Cell Lymphocytic Leukemia
For Condition: B-cell Chronic Lymphocytic Leukemia
Status: Recruiting
Sponsor(s): ILEX Pharmaceuticals ,
Synopsis: This is a Phase III, open-label, multicenter, randomized, comparative study of Campath versus chlorambucil as front line therapy in patients with progressive B-Cell Lymphocytic Leukemia (B-CLL). Eligible patients must have previously untreated, Rai stage I-IV disease, and be experiencing progression of their B-CLL requiring treatment. Patients who meet all eligibility criteria may be randomized on a 1:1 basis to receive either Campath or chlorambucil. An estimated 284 patients (142 per treatment arm) from approximately 40 or more investigational sites will be randomized to one of the two treatment arms.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: Patients must meet the following: - Histopathologically confirmed diagnosis of B-CLL with CD5, CD19, or CD23 positive clone. - Rai Stage I through IV disease with evidence of progression (specific factors detailed in Inclusion Criteria of the protocol). - Received no previous chemotherapy for B-CLL. - Life expectancy of at least 12 weeks. - WHO performance status of 0, 1, or 2. - Serum creatinine less or equal to 2.0 times the institutional upper limit of normal (ULN) value. - Adequate liver function as indicated by a total bilirubin, AST, and ALT less or equal to 2 times the institutional ULN value, unless directly attributable to the disease. - Female patients must have a negative serum pregnancy test within 2 weeks prior to randomization, and both men and women must agree to use an effective contraceptive method while on study and for a minimum of 6 months after study therapy. - Signed, written informed consent. - 18 years of age or older. Exclusion Criteria: Patients with or who meet the following will be excluded from study admission: - ANC less than 500 million per liter or platelet count less than 10 billion per liter. - Medical condition requiring chronic use of oral corticosteriods. - Autoimmune thrombocytopenia. - Previous bone marrow transplant. - Use of investigational agents within previous 30 days. - Positive for HIV. - Past history of anaphylaxis following exposure to rat or mouse-derived complementary determining region (CDR) grafted humanized monoclonal antibodies. - Active infection. - Serious cardiac or pulmonary disease that could interfere with their ability to participate in the study. - Recent documented (with in 2 years) of active tuberculosis (TB), current active TB, or currently receiving anti-tuberculosis medication. - Active secondary malignancy. - Central nervous system involvement with CLL. - Positive quantitative CMV by PCR assay (using the laboratory normal ranges). - A diagnosis of mantle cell lymphoma. - Other severe, concurrent diseases or mental disorders. - Pregnant or lactating women.
Total Enrollment: 284
Location and Contact Information:
Additional Information:
Study ID Numbers: CAM307;
Study Start Date: July 2001
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046683
Other B-Cell Chronic Lymphocytic Leukemia Studies:
1. Fludarabine and Cyclophosphamide With or Without Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
2. Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
3. 506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents
4. Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
5. Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients with Progressive B-Cell Lymphocytic Leukemia
Related Studies:
Other B-cell Chronic Lymphocytic Leukemia Clinical Trials
Other Nebraska Clinical Trials
Other Omaha Clinical Trials
Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients with Progressive B-Cell Lymphocytic Leukemia
|
|
|
|
|
|
|
|
