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Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia Clinical research trials and Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia. Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia clinical trial. Participants oftentimes recieve the finest healthcare available for their Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia  Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia
Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia
For Condition: stage 3 chronic lymphocytic leukemia,stage 1 chronic lymphocytic leukemia,stage 2 chronic lymphocytic leukemia,stage 4 chronic lymphocytic leukemia,B-cell Chronic Lymphocytic Leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of fludarabine in treating patients who have chronic lymphocytic leukemia that has not been previously treated.
Details: OBJECTIVES: - Determine the overall response rate (complete and partial) in patients with previously untreated B-cell chronic lymphocytic leukemia treated with oral fludarabine. - Determine the molecular complete response rate in patients who achieve a clinical or immunophenotypic complete response when treated with this drug. - Determine the progression-free and treatment-free survival of patients treated with this drug. - Determine the toxicity of this drug in these patients. - Determine the baseline incidence of defined genetic abnormalities in patients treated with this drug. - Determine the prognostic and predictive significance of defined genetic abnormalities in patients with respect to response to treatment with this drug. - Determine the prognostic and predictive significance of immunophenotypic profile of patients with respect to response to treatment with this drug. OUTLINE: This is a multicenter study. Patients receive oral fludarabine on days 1-5. Treatment repeats every 28 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission after 6 courses do not receive further study therapy. Patients are followed at 2 months and then every 4 months for 2 years. PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL) - Previously untreated - Rai stage I, II, III, or IV - Requiring systemic therapy - Persistent lymphocytosis of greater than 5,000/mm - Morphologically mature lymphocytes - Monoclonal B-cell population - CD19/CD5/CD23 positive with kappa or lambda light chain restriction by immunophenotyping - No other lymphoproliferative disorders including prolymphocytic leukemia, mantle cell lymphoma, progression to aggressive B-cell lymphoma, or Richter's syndrome - No clinical autoimmune hematologic complication of CLL including Coomb's-positive hemolytic anemia or immune thrombocytopenia - Positive Coomb's test allowed if no clinical hemolysis PATIENT CHARACTERISTICS: Age - 16 and over Performance status - ECOG 0-2 Life expectancy - At least 6 months Hematopoietic - See Disease Characteristics Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST and/or ALT no greater than 2 times ULN Renal - Creatinine no greater than 2 times ULN Other - Accessible for treatment and follow-up - No known HIV infection - No active bacterial, viral, or fungal infection requiring systemic antibiotics - No conditions requiring corticosteroid therapy - No history of other malignancies except for the following: - Adequately treated nonmelanoma skin cancer - Curatively treated carcinoma in situ of the cervix - Other solid tumors curatively treated with no evidence of disease within the past 5 years - No other major medical illness that would preclude study - No known hypersensitivity to fludarabine or its components - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunotherapy including monoclonal antibody therapy - No concurrent autologous or allogeneic stem cell or bone marrow transplantation Chemotherapy - No other concurrent cytotoxic drugs Endocrine therapy - No concurrent corticosteroids except inhaled or topical corticosteroids - No concurrent corticosteroids for nausea prophylaxis Radiotherapy - No prior radiotherapy affecting more than 25% of bone marrow and/or involving the pelvic area - No concurrent radiotherapy Surgery - Not specified Other - At least 4 weeks since prior investigational agents - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RalphMeyer, Study Chair, Margaret and Charles Juravinski Cancer Centre
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, P3E 5J1
Canada
Algoma Reginal Cancer Program at Sault Area Hospital
Sault Sainte Marie, Ontario, P6B 1Y5
Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, L2R 5K3
Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Canada
Grand River Regional Cancer Centre
Kitchner, Ontario, N2G 1G3
Canada
Humber River Regional Hospital - Weston
Weston, Ontario, M9N 1N8
Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Canada
Centre Jean Bernard
Le Mans, , 72000
France
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Centre Hospitalier Lyon Sud
Pierre-Benite, , 69495
France
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1
Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
McGill University
Montreal, Quebec, H2W 1S6
Canada
St. Joseph's Health Centre - Toronto
Toronto, Ontario, M6R 1B5
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L 4MI
Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1
Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Canada
Durham Regional Cancer Centre at Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Canada
Hopital de L'Enfant Jesus
Quebec City, Quebec, G1J 1Z4
Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada
Moncton Hospital
Moncton, New Brunswick, E1C 6ZB
Canada
Hopital du Saint-Sacrement, Quebec
Quebec City, Quebec, G1S 4L8
Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 8L6
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Providence Health Care - Vancouver
Vancouver, British Columbia, V6Z 1Y6
Canada
Additional Information:
Study ID Numbers: CDR0000257836; BRLX-304160,CAN-NCIC-CL2
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049075
Other Stage 1 Chronic Lymphocytic Leukemia Studies:
1. Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
2. Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia
3. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia
4. Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients with Progressive B-Cell Lymphocytic Leukemia
5. Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia
Related Studies:
Other stage 1 chronic lymphocytic leukemia Clinical Trials
Other Newfoundland and Labrador Clinical Trials
Other St. Johns Clinical Trials
Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia
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