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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00217594 |
RATIONALE: Immunosuppressive therapy with alemtuzumab and cyclosporine may improve bone marrow abnormalities and may be an effective treatment for myelodysplastic syndromes.
PURPOSE: This phase I/II trial is studying the side effects of giving alemtuzumab together with cyclosporine and to see how well it works in treating patients with myelodysplastic syndromes.
Condition | Intervention | Phase |
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Myelodysplastic Syndromes |
Drug: alemtuzumab Drug: cyclosporine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Pilot Study of Alemtuzumab (Campath®) in Patients With Myelodysplastic Syndrome (MDS) |
Estimated Enrollment: | 39 |
Study Start Date: | July 2005 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a non-randomized, open-label, pilot study.
Patients receive a test dose of alemtuzumab IV over 1 hour. If tolerated, patients receive alemtuzumab IV over 2 hours once daily for 10 days. Patients are evaluated for response at 3 months. Patients with disease progression or no response are removed from the study. Patients with relapsing disease after initial response may receive cyclosporine for 2-3 months or longer at the discretion of the investigator.
After completion of study treatment, patients are followed at 3 and 6 months and then annually for up to 5 years.
PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 72 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of myelodysplastic syndromes (MDS), including the following subtypes:
Meets 1 of the following hematologic parameters:
Anemia requiring transfusion support with ≥ 1 unit of packed red blood cells per month for ≥ 2 months accompanied with ≥ 1 of the following laboratory values:
Disease status must meet 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
NIH - Warren Grant Magnuson Clinical Center | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Patient Recruitment 800-411-1222 |
Principal Investigator: | Elaine Sloand, MD | National Heart, Lung, and Blood Institute (NHLBI) |
Responsible Party: | NHLBI - Hematology Branch ( Elaine Sloand ) |
Study ID Numbers: | CDR0000442361, NHLBI-05-H-0206 |
Study First Received: | September 20, 2005 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00217594 |
Health Authority: | Unspecified |
refractory anemia with excess blasts refractory anemia with ringed sideroblasts refractory anemia |
refractory cytopenia with multilineage dysplasia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes |
Myelodysplastic syndromes Cyclosporine Precancerous Conditions Clotrimazole Hematologic Diseases Refractory anemia Miconazole Myelodysplastic Syndromes Myelodysplasia |
Tioconazole Anemia Cyclosporins Preleukemia Anemia, Refractory Alemtuzumab Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases |
Anti-Infective Agents Disease Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Pathologic Processes Syndrome Antifungal Agents Therapeutic Uses Antirheumatic Agents Dermatologic Agents |