Clinical trial · Interventional
Azacitidine, Darbepoetin Alfa, and Erythropoietin and Filgastrim (G-CSF) in Treating Patients With Myelodysplastic Syndromes
Combination of Azacitadine and Hematopoietic Growth Factors for Myelodysplastic Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitadine and Hematopoietic Growth Factors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Azacitadine and Hematopoietic Growth Factors
- description
- Combination of Azacitadine andHematopoietic Growth Factors
- interventionNames
- Drug: Azacitadine and Hematopoietic Growth Factors
Primary outcomes (2)
- measure
- Number of Participants With Complete Response
- timeFrame
- Approximately 112 days
- 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
- Rate of Major Hematological Improvement
- timeFrame
- Approximately 112 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 120 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available