TriangleNCT00398047 · REGISTRY CONDITION SEARCH
Azacitidine, Darbepoetin Alfa, and Erythropoietin and Filgastrim (G-CSF) in Treating Patients With Myelodysplastic Syndromes
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- TERMINATED
- Registry last update
- 2018-09-06
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Number of Participants With Complete Response
Rate of Major Hematological Improvement
Minor Hematological Improvements
Time to Progression to Acute Myeloid Leukemia (Blast ≥ 20%) or Death
Overall Survival
Change in Bone Marrow Apoptosis
Expression of p53 and p21
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- DISEASE CHARACTERISTICS: * Diagnosis of myelodysplastic syndromes (MDS) * Bone marrow aspirate and biopsy with karyotyping performed within the past 8 weeks * 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: * Symptomatic anemia requiring RBC transfusion for ≥ 3 months before study entry * Thrombocytopenia with ≥ 2 platelet counts \< 50,000/mm³ OR a significant hemorrhage requiring platelet transfusion * Neutropenia with an absolute neutrophil count \< 1,000/mm³ and an infection requiring IV antibiotics * No refractory anemia with excess blasts in transformation * No history of leukemia * No known primary or metastatic hepatic tumor PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 2 months * AST and ALT ≤ 2 times upper limit of normal * Creatinine \< 2.0 mg/dL * Serum vitamin B12 normal * Serum and/or red cell folate levels normal * Ferritin ≥ 50 ng/mL * Copper \> 40 µg/dL * Not pregnant or nursing * Fertile patients must use effective contraception * Negative pregnancy test PRIOR CONCURRENT THERAPY: * No prior azacitidine or decitabine * No prior therapy for MDS * Supportive therapy within the past 28 days allowed * No other concurrent treatment for MDS (i.e., thalidomide, arsenic trioxide, cyclosporine, or melphalan) * No other concurrent hematopoietic growth factors, including epoetin alfa, filgrastim (G-CSF), sargramostim (GM-CSF), or interleukin-11 (oprelvekin)
- healthy Volunteers
- false
- maximum Age
- 120 Years
- sex
- ALL
- std Ages
- CHILD
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Combination of Azacitadine andHematopoietic Growth Factors
- intervention Names
- Drug: Azacitadine and Hematopoietic Growth Factors
- label
- Azacitadine and Hematopoietic Growth Factors
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Azacitadine and Hematopoietic Growth Factors
- description
- Combination of Azacitadine and Hematopoietic Growth Factors
- name
- Azacitadine and Hematopoietic Growth Factors
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 3
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Complete response is normalization of abnormal blood counts, and disappearance of signs of morphological changes in the bone marrow. If the previously present cytogenetic abnormalities are absent then it is referred also as a cytogenetic complete remission.
- measure
- Number of Participants With Complete Response
- time Frame
- Approximately 112 days
- description
- For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for red cell transfusion-dependent patients, transfusion independence.
- measure
- Rate of Major Hematological Improvement
- time Frame
- Approximately 112 days
- secondary Outcomes
- description
- For patients with pretreatment platelet count less than 100,000/mm3, a 50% or more increase in platelet count with a net increase greater than 10,000/mm3 but less than 30,000/mm3
- measure
- Minor Hematological Improvements
- time Frame
- Approximately 112 days
- description
- Death during treatment or disease progression characterized by worsening of cytopenias, increase in the percentage of the blasts, reduction of hemoglobin concentration by at least 2 g/dl or transfusion dependence in the absence of another explanation, such as acute infection, gastrointestinal bleeding, hemolysis.
- measure
- Time to Progression to Acute Myeloid Leukemia (Blast ≥ 20%) or Death
- time Frame
- Approximately 12 months
- measure
- Overall Survival
- time Frame
- Approximately 12 months
- measure
- Change in Bone Marrow Apoptosis
- time Frame
- Baseline and approximately 12 months
- measure
- Expression of p53 and p21
- time Frame
- Approximately 12 months
Full study description
- brief Summary
- 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.
- detailed Description
- OBJECTIVES: Primary * Determine the hematological response rate in patients with myelodysplastic syndromes treated with azacitidine, darbepoetin alfa, and filgrastim (G-CSF). Secondary * Determine the time to leukemia progression, survival, and changes in apoptotic index of bone marrow in patients treated with this regimen. OUTLINE: This is an open-label, nonrandomized study. * Initial therapy (courses 1 and 2): Patients receive azacitidine subcutaneously (SC) or intra-venous (IV) on days 1-5 (week 1) and darbepoetin alfa\* SC on day 8 (week 2). Treatment repeats every 28 days for 2 courses. 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. * Optimization therapy A (courses 3-8): Patients receive azacitidine SC or IV on days 1-5 (week 1), darbepoetin alfa\*\* SC on day 8 (week 2), and filgrastim (G-CSF) SC 3 times weekly in weeks 2-4. * Optimization therapy B (courses 3-8): Patients receive a higher dose of azacitidine on days 1-5 (week 1), darbepoetin alfa\*\* SC on day 8 (week 2), and G-CSF 3 times weekly in weeks 2-4. In both optimization therapy A and B, treatment repeats every 28 days for 6 courses. Patients with any degree of hematological improvement after initial therapy and optimization therapy proceed to maintenance therapy. * Maintenance therapy (course 9 and all subsequent courses): Patients receive azacitidine on days 1-5 (week 1). Only patients with anemia (hemoglobin \< 12 g/dL) and/or neutropenia (absolute neutrophil count \< 1,500/mm ³) at the start of any given course during maintenance therapy receive darbepoetin alfa\*\* SC beginning on day 8 (week 2) and continuing once every 21 days and G-CSF SC 3 times weekly beginning in week 2. 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.
Source references
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice