Phase 2 Study Of Clofarabine With High Dose Cytarabine And G-CSF Priming In Adult Patients Less Than Age 65 With Newly Diagnosed Acute Myeloid Leukemia Or Advanced Myelodysplastic Syndrome and/or Advanced Myeloproliferative Neoplasm
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.
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
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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Up to 5 years
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
|Stanford University||Stanford, California 94305|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|City of Hope Medical Center||Duarte, California 91010|