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Epoetin alfa With or Without Filgrastim Compared With Blood Transfusions in Treating Patients With Myelodysplastic Syndrome Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Epoetin alfa With or Without Filgrastim Compared With Blood Transfusions in Treating Patients With Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Epoetin alfa With or Without Filgrastim Compared With Blood Transfusions in Treating Patients With Myelodysplastic Syndrome Clinical research trials and Epoetin alfa With or Without Filgrastim Compared With Blood Transfusions in Treating Patients With Myelodysplastic Syndrome health trials take place in a lot of of cities across the US. 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 / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Epoetin alfa With or Without Filgrastim Compared With Blood Transfusions in Treating Patients With Myelodysplastic Syndrome. Epoetin alfa With or Without Filgrastim Compared With Blood Transfusions in Treating Patients With Myelodysplastic Syndrome Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Epoetin alfa With or Without Filgrastim Compared With Blood Transfusions in Treating Patients With Myelodysplastic Syndrome clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Epoetin alfa With or Without Filgrastim Compared With Blood Transfusions in Treating Patients With Myelodysplastic Syndrome condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Epoetin alfa With or Without Filgrastim Compared With Blood Transfusions in Treating Patients With Myelodysplastic Syndrome  Epoetin alfa With or Without Filgrastim Compared With Blood Transfusions in Treating Patients With Myelodysplastic Syndrome
Epoetin alfa With or Without Filgrastim Compared With Blood Transfusions in Treating Patients With Myelodysplastic Syndrome
For Condition: Anemia,Quality of Life,Myelodysplastic Syndromes
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Epoetin alfa and colony-stimulating factors such as filgrastim stimulate the production of blood cells. It is not yet known whether epoetin alfa with or without filgrastim is more effective than standardblood transfusions in reducing the need for transfusions in patients who have anemia associated with myelodysplastic syndrome. PURPOSE: Randomizedphase III trial to compare the effectiveness of epoetin alfa with or without filgrastim with that of standard blood transfusions in reducing the need for transfusions in patients who have anemia associated with myelodysplastic syndrome.
Details: OBJECTIVES: - Compare the benefit of epoetin alfa vs standard transfusion support in reducing transfusion requirements in patients with myelodysplastic syndromes. - Compare the clinical response, disease progression, and survival in patients treated with these regimens. - Compare the toxicity of these regimens in these patients. - Determine the effect of pretreatment epoetin alfa levels on the response to epoetin alfa in these patients. - Evaluate whether adding filgrastim (G-CSF) or increasing the epoetin alfa dose will reduce the transfusion requirement in patients who do not respond to epoetin alfa alone. - Assess quality of life (QOL) of these patients and determine whether either cross-sectional or longitudinal differences in patients' QOL and fatigue are correlated with the use of the growth factors. OUTLINE: This is a randomized, controlled, multicenter, cross-over study. Patients are stratified according to morphologic subtype (refractory anemia [RA] vs RA with ringed sideroblasts vs RA with excess blasts), transfusion requirement (yes vs no), prior epoetin alfa treatment (yes vs no), and epoetin alfa level (at least 200 mU/mL vs less than 200 mU/mL). Patients are randomized to one of two treatment arms. - Arm I (standard transfusion support): Patients receive red cell and platelet transfusions for symptoms or to maintain hematocrit level of 25% or above. Patients undergo bone marrow aspirate and biopsy at 4 months and then every year until development of acute leukemia or completion of study. Patients with progressive disease may cross over to arm II after at least 4 months on study and up to 1 year from the time of randomization. Patients who cross over receive epoetin alfa alone. - Patients receive epoetin alfa subcutaneously (SC) or IV daily. Patients undergo bone marrow aspirate and biopsy as in arm I. Treatment continues daily for a maximum of 1 year. Patients with stable or progressive disease at day 120 receive filgrastim (G-CSF) SC daily or 3 days a week and epoetin alfa SC daily for up to 6 months. Patients with no response to G-CSF and lower-dose epoetin alfa may proceed to a higher dose of epoetin alfa. Quality of life is assessed at baseline, every 4 months during study, and at study completion. Patients are followed every 4 months for 2 years, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 139 patients will be accrued for this study within 3.6 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven myelodysplastic syndromes - Refractory anemia (RA) - RA with ringed sideroblasts - RA with excess blasts (RAEB) - RAEB patients must have a bone marrow blast count of less than 20% and less than 5% blast forms on peripheral blood - No RAEB in transformation - No chronic myelomonocytic leukemia - Secondary myelodysplastic syndromes allowed - No splenomegaly greater than 6 cm below the left costal margin or greater than 3 times normal size PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-3 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics - Platelet count greater than 30,000/mm^3 (without platelet transfusions) - Hematocrit less than 30% (pretransfusion) Hepatic: - Bilirubin less than 3 mg/dL Renal: - BUN less than 40 mg/dL OR - Creatinine less than 2.0 mg/dL Cardiovascular: - No uncontrolled hypertension Other: - No sensitivity to E. coli-derived proteins - No sensitivity to epoetin alfa or any of its components (e.g., human albumin) - No documented iron deficiency - If marrow iron stain is not available, the transferrin saturation must be greater than 20% or ferritin greater than 100 ng/dL - No active infection or bleeding - No other uncontrolled malignancy - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior epoetin alfa allowed provided dosage was less than 30,000 units per week for less than 1 month duration - At least 1 month since prior epoetin alfa - At least 2 months since prior recombinant growth factor Chemotherapy: - At least 2 months since prior chemotherapy for other malignancy or autoimmune disease Endocrine therapy: - At least 2 weeks since prior androgens or steroids for treatment of myelodysplastic syndromes Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KennethMiller, Study Chair, Beth Israel Deaconess Medical Center
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226-3596
United States
Recruiting David Vesole 414-805-4646
Cancer Institute of New Jersey *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Joseph Aisner 732-235-7464
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting Edward Mansour 216-778-4394
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting John Erban 617-636-5147
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton 702-384-0013
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - Northern New Jersey *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Richard Rosenbluth 201-996-5917
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
CCOP - Colorado Cancer Research Program, Incorporated *Recruiting*
Denver, Colorado, 80224
United States
Recruiting Eduardo Pajon 303-777-2663
Additional Information:
Study ID Numbers: CDR0000065907; ECOG-1996
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003138
Other Anemia Studies:
1. Treatment of Anemia in Patients with Cancer who Are Not Currently Receiving Chemotherapy or Radiotherapy
2. Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
3. Anemia in Patients with a Non-Myeloid Malignancy
4. Darbepoetin alfa in Treating Anemia in Patients With Cancer Who Are Receiving Chemotherapy
5. Ro 50-3821 in Treating Anemia in Patients Receiving Antineoplastic Therapy for Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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Epoetin alfa With or Without Filgrastim Compared With Blood Transfusions in Treating Patients With Myelodysplastic Syndrome
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