Decitabine, Cytarabine, GCSF for Refractory AML/MDS
This study will determine the activity of decitabine, low dose cytarabine (ARA-C) and G-CSF for patients with myelodysplasia and leukemia.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study With Decitabine, Low Dose Cytarabine and G-CSF in High-risk Myelodysplastic Syndromes, Refractory Acute Myeloid Leukemia or Acute Myeloid Leukemia in Patients With Significant Co-morbidities.|
- Response Rate [ Time Frame: within 30 days of last treatment ] [ Designated as safety issue: No ]
Complete Response/Complete Remission:
Complete remission (CR) is defined as the presence of all of the following:
- Peripheral blood - No leukemic blasts present.
- No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement)
- Bone marrow
- No Auer rods
- Less than 5% blast cells.
- CBC and bone marrow criteria must be met within one week of each other.
- Hemoglobin 9g/dl or greater
- Neutrophil count >1000 and platelet count >100,000.
- RBC Transfusion free for 2 weeks.
|Study Start Date:||August 2008|
|Study Completion Date:||April 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
The primary objective of this study is to determine the feasibility and toxicity of decitabine, ARA-C and G-CSF for patients with myelodysplasia, refractory acute leukemia and poor performance status acute leukemia.
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||James Butera||Brown University|