Azacitidine, Darbepoetin Alfa, and Erythropoietin and Filgastrim (G-CSF) in Treating Patients With Myelodysplastic Syndromes

NCT00398047 | Terminated Phase 2 Results FDA Drug

• 3 other identifiers: CDR0000515108P30CA012197CCCWFU-29106
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia; Myelodysplastic Syndromes

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Complete Response

  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.

  Approximately 112 days

• Rate of Major Hematological Improvement

  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.

  Approximately 112 days

Secondary Outcomes (5)

• Minor Hematological Improvements

  Approximately 112 days

• Time to Progression to Acute Myeloid Leukemia (Blast ≥ 20%) or Death

  Approximately 12 months

• Overall Survival

  Approximately 12 months

• Change in Bone Marrow Apoptosis

  Baseline and approximately 12 months

• Expression of p53 and p21

  Approximately 12 months

Study Arms (1)

Azacitadine and Hematopoietic Growth Factors

EXPERIMENTAL

Combination of Azacitadine andHematopoietic Growth Factors

Drug: Azacitadine and Hematopoietic Growth Factors

Interventions

Azacitadine and Hematopoietic Growth Factors DRUG

Combination of Azacitadine and Hematopoietic Growth Factors

Azacitadine and Hematopoietic Growth Factors

Eligibility Criteria

• Age: Up to 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Anemia, Refractory, with Excess of Blasts; Anemia, Refractory; Leukemia, Myelomonocytic, Chronic

Interventions

Hematopoietic Cell Growth Factors

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Anemia; Leukemia, Myeloid; Myelodysplastic-Myeloproliferative Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Ralph D'Agostino Jr., Ph.D.
• Organization: Wake Forest University Health Sciences

rdagosti@wfubmc.edu

113-716-3483

Study Officials

• Bayard L. Powell, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 10, 2006
• Study Start: September 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 6, 2018
• Results First Posted: April 17, 2012

Record last verified: 2018-08

Locations

US (1)