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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00398047 |
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as darbepoetin alfa and G-CSF, may increase the number of red blood cells and white blood cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving azacitidine together with darbepoetin alfa and G-CSF may be an effective treatment for myelodysplastic syndromes.
PURPOSE: This clinical trial is studying how well giving azacitidine together with darbepoetin alfa and G-CSF works in treating patients with myelodysplastic syndromes.
Condition | Intervention |
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Leukemia Myelodysplastic Syndromes |
Biological: darbepoetin alfa Biological: filgrastim Drug: azacitidine Genetic: microarray analysis Other: flow cytometry Other: immunohistochemistry staining method Procedure: biopsy |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Combination of Azacitadine and Hematopoietic Growth Factors for Myelodysplastic Syndrome |
Estimated Enrollment: | 36 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, nonrandomized study.
Patients undergo bone marrow aspirate and biopsy to assess response. Patients with a major hematological improvement OR with grade 3-4 hematological toxicities during the first 2 courses of therapy AND/OR ≥ 50% reduction in bone marrow cellularity compared to baseline proceed to optimization therapy A. Patients not meeting any of the above criteria proceed to optimization therapy B. Patients with disease progression are removed from study.
Only patients with anemia (hemoglobin < 12 g/dL) and/or neutropenia (absolute neutrophil count < 1,500/mm
Courses repeat every 28-56 days (determined by the treating physician) in the absence of disease progression or unacceptable toxicity.
Bone marrow samples are obtained at baseline and after the completion of course 2 of study treatment for apoptosis analysis, flow cytometry, and gene expression profiles of p53 and p21 by immunohistochemistry.
Peripheral blood samples are obtained periodically and analyzed for hemoglobin F quantitation.
NOTE: *Administered only if the patient is anemic (hemoglobin < 12 g/dL).
NOTE: **Darbepoetin alfa is held if hemoglobin > 12 g/dL on day 1 of a given cycle.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of myelodysplastic syndromes (MDS)
Patients with chronic myelomonocytic leukemia (CMML), refractory anemia (RA), or refractory anemia with ringed sideroblasts (RARS) according to FAB classification OR RA, RARS, refractory anemia with multilineage dysplasia, or RARS with multilineage dysplasia according to WHO classification must meet ≥ 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior therapy for MDS
United States, North Carolina | |
Wake Forest University Comprehensive Cancer Center | |
Winston-Salem, North Carolina, United States, 27157-1096 |
Principal Investigator: | Bayard L. Powell, MD | Wake Forest University |
Study ID Numbers: | CDR0000515108, CCCWFU-29106 |
Study First Received: | November 9, 2006 |
Last Updated: | June 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00398047 History of Changes |
Health Authority: | United States: Federal Government |
de novo myelodysplastic syndromes refractory anemia with ringed sideroblasts refractory anemia with excess blasts refractory anemia |
refractory cytopenia with multilineage dysplasia chronic myelomonocytic leukemia secondary myelodysplastic syndromes childhood myelodysplastic syndromes |
Antimetabolites Chronic Myelomonocytic Leukemia Precancerous Conditions Hematinics Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Darbepoetin alfa Anemia |
Refractory Anemia Leukemia Preleukemia Anemia, Refractory Azacitidine Neoplasm Metastasis Mitogens Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases |
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Precancerous Conditions Hematinics Antineoplastic Agents Hematologic Diseases Hematologic Agents Myelodysplastic Syndromes |
Darbepoetin alfa Enzyme Inhibitors Pharmacologic Actions Leukemia Preleukemia Neoplasms Pathologic Processes Therapeutic Uses Syndrome Azacitidine Bone Marrow Diseases |