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Safety and efficacy of CC-5013 monotherapy in subjects with myelodysplastic syndromes associated with a del (5q) cytogenetic abnormality Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Safety and efficacy of CC-5013 monotherapy in subjects with myelodysplastic syndromes associated with a del (5q) cytogenetic abnormality conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Safety and efficacy of CC-5013 monotherapy in subjects with myelodysplastic syndromes associated with a del (5q) cytogenetic abnormality Clinical research trials and Safety and efficacy of CC-5013 monotherapy in subjects with myelodysplastic syndromes associated with a del (5q) cytogenetic abnormality medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Safety and efficacy of CC-5013 monotherapy in subjects with myelodysplastic syndromes associated with a del (5q) cytogenetic abnormality. Safety and efficacy of CC-5013 monotherapy in subjects with myelodysplastic syndromes associated with a del (5q) cytogenetic abnormality Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Safety and efficacy of CC-5013 monotherapy in subjects with myelodysplastic syndromes associated with a del (5q) cytogenetic abnormality clinical trial. Subjects often receive the most expert healthcare possible for their Safety and efficacy of CC-5013 monotherapy in subjects with myelodysplastic syndromes associated with a del (5q) cytogenetic abnormality condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and efficacy of CC-5013 monotherapy in subjects with myelodysplastic syndromes associated with a del (5q) cytogenetic abnormality  Safety and efficacy of CC-5013 monotherapy in subjects with myelodysplastic syndromes associated with a del (5q) cytogenetic abnormality
Safety and efficacy of CC-5013 monotherapy in subjects with myelodysplastic syndromes associated with a del (5q) cytogenetic abnormality
For Condition: Myelodysplastic Syndromes
Status: No longer recruiting
Sponsor(s): Celgene Corporation ,
Synopsis: This study is a multicenter, single-arm, open-label study of oral CC-5013 monotherapy administered to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk MDS associated with a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of the first day of CC-5013 treatment. Subjects will receive CC-5013 in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement (Appendix I) is documented. Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Must understand and voluntarily sign an informed consent form - Age 18 years or older at the time of signing the informed consent - Must be able to adhere to the study visit schedule and other protocol requirements. - Diagnosis of low or intermediate-1-risk IPSS (Appendix III) MDS without an abnormality of chromosome 5 involving a deletion between bands q31 and q33. - Red blood cell (RBC) transfusion-dependent anemia defined as having received greater than or equal to 2 units of RBCs within 8 weeks of the first day of study drug treatment. - Eastern Cooperative Oncology Group (ECOG) (Appendix IV) performance status score of 0,1, or 2. - Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. - Sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. - WCBP must agree to have pregnancy tests every 4 weeks while on study drug. Exclusion Criteria: - Pregnant or lactating females - Prior therapy with CC-5013. - An abnormality of chromosome 5 involving a deletion between bands q31 and q33. - Lab Abnormality: Absolute neutrophil count (ANC) <500 cell/mm3 (0.5 x 109/L) - Lab Abnormality: Platlet count <50,000/mm3 (50 x 109/L) - Lab Abnormality: Serum creatinine >2.5 mg/dL (221 mmol/L) - Lab Abnormality: Serum total bilirubin >2.0 mg/dL (34 mmol/L) - Prior greater than or equal to grade 3 National Cancer Institute (NCI) Common Toxicity Criteria (CTC) (Appendix VI) allergic reaction/hypersensitivity to thalidomide. - Clinically significant anemia due to factors such as iron, B12 or folate deficiencies, autoimmune or hereditary hemolysis or gastrointestinal bleeding - If a marrow aspirate is not evaluable for storage iron, transferrin saturation must be > 20% and serum ferritin not less than 50 ng/mL - Use of hematopoietic growth factors within 7 days of the first day of study drug treatment. - Prior greater than or equal to grade 3 NCI CTC (Appendix VI) rash or any desquamation (blistering) while taking thalidomide. - Chronic use (>2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to >10 mg/day of prednisone) within 28 days of the first day of study drug treatment. - Use of experimental or standard drugs (i.e. chemotherapeutic, immunosuppressive, and cytoprotective agents) for the treatment of MDS within 28 days of the first day of study drug treatment. - Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for greater than or equal to 3 years. - Use of any other experimental therapy within 28 days of the first day of study drug treatment.
Total Enrollment: 90
Location and Contact Information:
Midwest Cancer Research Group
Skokie, Illinois, 60077
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Wayne State University School of Medicine
Detroit, Michigan, 48201-2097
United States
Arizona Cancer Center
Scottsdale, Arizona, 85258
United States
Mt. Sinai Medical Center
New York City, New York, 10029
United States
Arizona Cancer Center
Tucson, Arizona, 85724-5024
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Mayo Clinic
Scottsdale, Arizona, 85259
United States
University of Chicago Medical Center
Chicago, Illinois, 60637-1470
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21287-8963
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021-6007
United States
University of Rochester- James P. Wilmot Cancer Center
Rochester, New York, 14642
United States
St. Johannes Hospital
Duisburg, ,
Germany
Northwest Georgia Oncology - Wellstar Cancer Research
Marietta, Georgia, 30060
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
New York Hospital-Cornell
New York City, New York, 10021-0034
United States
Kaiser Permanente Northwest Region
Portland, Oregon, 97227
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Desert Hematology & Oncology Medical Group
Rancho Mirage, California, 92270
United States
Wake Forest University School of Medicine
Winston Salem, North Carolina, 27157-1082
United States
University of Miami Sylvester Comp Cancer Center
Miami, Florida, 33136
United States
Stanford University Medical Center
Stanford, California, 94305-5750
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-4417
United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, 15224
United States
Cancer & Blood Disease Center
Lecanto, Florida, 34461
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115-6084
United States
Rush-Presbyterian- St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Oregon Health & Science University
Portland, Oregon, 97201
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Additional Information:
Study ID Numbers: CC-5013-MDS-003;
Study Start Date: June 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065156
Other Myelodysplastic Syndromes Studies:
1. Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes
2. A Survival Study in Patients with High Risk Myelodysplastic Syndromes Comparing Azacitidine versus Conventional Care
3. Biological Therapy in Treating Patients With Myelodysplastic Syndrome
4. Umbilical Cord Blood Transplantation in Treating Patients With Severe Aplastic Anemia, Malignant Thymoma, or Myelodysplasia
5. A Randomized Trial of Antithymocyte Globulin versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome
Related Studies:
Other Myelodysplastic Syndromes Clinical Trials
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Safety and efficacy of CC-5013 monotherapy in subjects with myelodysplastic syndromes associated with a del (5q) cytogenetic abnormality
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