|
Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes Clinical research trials and Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes. Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes clinical trial. Participants frequently get the best healthcare available for their Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "D" Clinical Trials Conditions > Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes  Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes
Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes
For Condition: previously treated myelodysplastic syndromes,de novo myelodysplastic syndromes,secondary myelodysplastic syndromes,Refractory Anemia,refractory anemia with excess blasts,refractory anemia with ringed sideroblasts
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: RATIONALE: Immunosuppressive therapies, such as daclizumab and antithymocyte globulin, may improve bone marrow abnormalities and increase blood cell counts. It is not yet known whether daclizumab is more effective than antithymocyte globulin in treating cytopenia caused by myelodysplastic syndrome. PURPOSE: Randomizedphase II trial to compare the effectiveness of daclizumab with that of antithymocyte globulin in treating patients who have cytopenia caused by myelodysplastic syndrome.
Details: OBJECTIVES: - Confirm the efficacy of anti-thymocyte globulin (ATG) in alleviating cytopenia in patients with myelodysplastic syndromes who have a high or intermediate predicted probability of response. - Determine whether daclizumab produces comparable responses to that of ATG in alleviating cytopenia in these patients. - Determine whether the frequency of life-threatening drug-related toxicity of daclizumab is significantly less than that of ATG in these patients. - Assess the impact of treatment and responses to treatment on karyotype abnormalities in these patients. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive anti-thymocyte globulin (ATG) IV on days 1-4 and oral prednisone on days 1-17. - Arm II: Patients receive daclizumab IV over 15 minutes on day 1 of weeks 0, 2, 4, 6, and 8. Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. Patients in either arm who relapse or do not respond to therapy within 6 months may cross over to the other arm. Patients on arm I who have persistent severe infusion reaction to ATG despite treatment may cross over to arm II two weeks after stopping ATG. Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 132 patients (66 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of 1 of the following myelodysplastic syndromes (MDS): - Refractory anemia (RA) - RA with ringed sideroblasts - RA with excess blasts (RAEB) - Must meet criteria for 1 of the following: - Anemia requiring at least 1 unit of transfused packed red blood cells per month for at least 2 months - Thrombocytopenia (platelet count less than 50,000/mm^3) - Neutropenia (absolute neutrophil count less than 500/mm^3) - High or intermediate predicted probability of response - No chronic myelomonocytic leukemia - No transformation to acute leukemia (i.e., RAEB in transformation [greater than 20% blasts in marrow aspirate]) - No hypoplastic marrow without 1 major or 2 minor criteria - Not eligible for bone marrow transplantation PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - More than 3 months - No moribund patients Hematopoietic - See Disease Characteristics Hepatic - No concurrent hepatic disease that would limit life expectancy Renal - Creatinine no greater than 2 mg/dL - No concurrent renal disease that would limit life expectancy Cardiovascular - No concurrent cardiac disease that would limit life expectancy Immunologic - HIV negative - No active uncontrolled infection - No chronic or other current clinically significant infection Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other active malignant disease except basal cell carcinoma - No concurrent metabolic or other disease that would limit life expectancy PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior growth factors (except filgrastim [G-CSF]) - Prior or concurrent G-CSF allowed for patients with documented neutropenia provided they meet criteria for anemia and/or thrombocytopenia Chemotherapy - Prior chemotherapy for MDS allowed Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - Prior experimental agents (e.g., retinoids or cholecalciferol [vitamin D]) for MDS allowed - At least 4 weeks since other prior therapy for MDS (except G-CSF, transfusion support, and related medications) - More than 4 weeks since prior cyclosporine - More than 24 hours since prior Echinacea purpurea or Usnea barbata - No concurrent Echinacea purpurea or Usnea barbata - No concurrent immunosuppressants
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ElaineSloand, Study Chair, Hematology Branch, NHLBI
Warren Grant Magnuson Clinical Center *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 800-411-1222
Additional Information:
Study ID Numbers: CDR0000346846; NHLBI-04-H-0026
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075530
Other De Novo Myelodysplastic Syndromes Studies:
1. Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
2. Low-Dose Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorder or Myelodysplastic Syndrome
3. Antithymocyte Globulin and Cyclosporine Compared With Standard Therapy in Treating Patients With Myelodysplastic Syndrome
4. Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes
5. Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome
Related Studies:
Other de novo myelodysplastic syndromes Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes
|
|
|
|
|
|
|
|
