Decitabine, Cytarabine, GCSF for Refractory AML/MDS
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|ClinicalTrials.gov Identifier: NCT00740181|
Recruitment Status : Terminated (Lack of efficacy)
First Posted : August 22, 2008
Results First Posted : July 2, 2013
Last Update Posted : August 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplasia Leukemia||Drug: chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||August 2008|
|Primary Completion Date :||February 2010|
|Study Completion Date :||April 2010|
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
- Response Rate [ Time Frame: within 30 days of last treatment ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740181
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||James Butera||Brown University|