This phase II trial is studying how well giving clofarabine and cytarabine together with filgrastim works in treating patients with newly diagnosed acute myeloid leukemia (AML), advanced myelodysplastic syndrome (MDS), and/or advanced myeloproliferative neoplasm. Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different doses may kill more cancer cells. Colony stimulating factors, such as filgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy.
PRIMARY OBJECTIVES: I. To assess the complete remission (CR) rate of this regimen as compared with 7 + 3 standard induction with the 90 mg/m\^2/dose of daunorubicin (historical control) in previously untreated patients with AML or advanced MDS or advanced myeloproliferative neoplasm less than age 65. SECONDARY OBJECTIVES: I. To determine the event free survival (EFS), overall survival (OS) and treatment related mortality of this regimen. II. To assess the toxicity of this regimen in previously untreated patients. III. To determine whether 3 consolidation chemotherapy cycles consisting of G-CSF (filgrastim), clofarabine, and cytarabine (GCLAC) can be administered with prompt recovery of blood counts. OUTLINE: INDUCTION THERAPY: Patients receive filgrastim subcutaneously (SC) daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine intravenously (IV) over 1 hour followed by cytarabine IV over 2 hours daily for 5 days. CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days. Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then annually for 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
City of Hope Medical Center
Duarte, California, United States
Stanford University
Stanford, California, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts
With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. Complete remission is defined as less than 5% blast cells present in the bone marrow and count recovery (absolute neutrophil count greater than 1000/microL and platelet count greater than 100,000/microL). Complete remission with incomplete recovery of counts is defined as less than 5% blast cells present in the bone marrow without compete count recovery (absolute neutrophil count less than 1000/microL and platelet count less than 100,000/microL).
Time frame: Up to 5 years
Duration of Remission
With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. Remission is defined as less than 5% blasts in the bone marrow, no appearance of blasts in the peripheral blood, and no extramedullary disease (appearance of leukemic cells in other tissues).
Time frame: Up to 5 years
Time to Progression
With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates.
Time frame: Up to 5 years
Event Free Survival
Number of patients in remission at a median follow up of 15 months.
Time frame: Up to 5 years
Treatment-related Mortality (TRM)
Treatment-related mortality (TRM) data was not collected.
Time frame: Up to 5 years
Overall Survival
With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates.
Time frame: Up to 5 years
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