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Efficacy and safety study of CC-5013 monotherapy in subjects with myelodysplastic syndromes Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Efficacy and safety study of CC-5013 monotherapy in subjects with myelodysplastic syndromes conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Efficacy and safety study of CC-5013 monotherapy in subjects with myelodysplastic syndromes Clinical research trials and Efficacy and safety study of CC-5013 monotherapy in subjects with myelodysplastic syndromes healthcare trials happen in hundreds of localities throughout 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Efficacy and safety study of CC-5013 monotherapy in subjects with myelodysplastic syndromes. Efficacy and safety study of CC-5013 monotherapy in subjects with myelodysplastic syndromes Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Efficacy and safety study of CC-5013 monotherapy in subjects with myelodysplastic syndromes clinical trial. Subjects frequently obtain the most expert healthcare possible for their Efficacy and safety study of CC-5013 monotherapy in subjects with myelodysplastic syndromes condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Efficacy and safety study of CC-5013 monotherapy in subjects with myelodysplastic syndromes  Efficacy and safety study of CC-5013 monotherapy in subjects with myelodysplastic syndromes
Efficacy and safety study of CC-5013 monotherapy in subjects with myelodysplastic syndromes
For Condition: Myelodysplastic Syndromes
Status: No longer recruiting
Sponsor(s): Celgene Corporation ,
Synopsis: This study is a multi-center, single-arm, open-label study of oral CC-5013 monotherapy administered at a dose of 10 mg daily on Days 1-21 every 28 days (28-day cycles) to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk MDS who do not have a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of first day of study drug treatment. Subjects will receive study drug (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 form. - 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 cells/mm3 (0.5 x 109/L) - Lab Abnormality: Platelet count <50,000/mm3 (50 x 109/L) - Lab Abnormality: Serum creatinine >2.5 mg/dL (221 mmol/L) - Lab Abnormality: Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN) - 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. - Prior greater than or equal to grade 3 NCI CTC (Appendix VI) rash or any desquamation (blistering) while taking 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. - 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: 136
Location and Contact Information:
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Rush Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612-3515
United States
Wake Forest University School of Medicine
Winston Salem, North Carolina, 27157-1082
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-4417
United States
Cancer & Blood Disease Center
Lecanto, Florida, 34461
United States
Winthrop University Hospital
Mineola, New York, 11501-3893
United States
University of Rochester-James P. Wilmot Cancer Center
Rochester, New York, 14642
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Midwest Cancer Research Group
Skokie, Illinois, 60077
United States
Florida Cancer Specialists
Ft. Myers, Florida, 33901
United States
Stanford University Medical Center
Stanford, California, 94305-5750
United States
University of Miami- Sylvester Comp Cancer Center
Miami, Florida, 33136
United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, 15224
United States
Alta Bates Cancer Center
Berkeley, California, 94704
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
University of Chicago Medical Center
Chicago, Illinois, 60637-1470
United States
Oregon Health & Science University
Portland, Oregon, 97201
United States
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, 92270
United States
Wayne State University School of Medicine
Detroit, Michigan, 48201-2097
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115-6084
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Indiana University Medical Center
Indianapolis, Indiana, 46202-5149
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Kaiser Permanente Northwest Region
Portland, Oregon, 97227
United States
Mayo Clinic
Scottsdale, Arizona, 85259
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21287-8963
United States
Arizona Cancer Center
Tucson, Arizona, 85724-5024
United States
St. Luke's Oncology and Hematology Associates
Duluth, Minnesota, 55805
United States
St. Vincents Comprehensive Cancer Center
New York City, New York, 10011
United States
Arizona Cancer Center
Scottsdale, Arizona, 85258
United States
Mt. Sinai Medical Center
New York City, New York, 10029
United States
Northwest Georgia Oncology - Wellstar Cancer Research
Marietta, Georgia, 30060
United States
New York Hospital- Cornell
New York City, New York, 10021-0034
United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19129
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-002;
Study Start Date: June 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064974
Other Myelodysplastic Syndromes Studies:
1. Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes
2. Study of Allogeneic Bone Marrow Transplantation Following Cyclophosphamide and Radiotherapy in Patients With Myelodysplastic Syndrome and Acute Leukemia Related to Fanconi's Anemia
3. Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
4. Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias
5. HLA-Mismatched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematological Malignancies
Related Studies:
Other Myelodysplastic Syndromes Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Efficacy and safety study of CC-5013 monotherapy in subjects with myelodysplastic syndromes
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