Status:
UNKNOWN
Azacytidine Plus FLAG for Relapsed or Refractory AML
Lead Sponsor:
King Fahad Medical City
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
16-60 years
Phase:
PHASE2
Brief Summary
The purpose of this phase 2 study is to test the efficacy of azacytidine given prior to fludarabine, cytarabine, and G-CSF for the treatment of relapsed or refractory acute myeloid leukemia.
Eligibility Criteria
Inclusion
- Age 16 to 60
- Patients with a diagnosis of relapse or refractory AML (≥ 20% blast in bone marrow).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Patients must have preserved organ function as defined below:
- Creatinine ≤ 1.5 mg/dl
- Total bilirubin ≤ 1.5x upper limit of the normal
- Alanine aminotransferase (ALT) ≤ 2x upper limit of the normal
- Left ventricular ejection fraction (LVEF) ≥ 45%
Exclusion
- Patients with a diagnosis of acute promyelocytic leukemia (AML -M3)
- Pregnant women
- Patients previously treated with fludarabine are allowed to participate.
- Patients with Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2018
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT02275663
Start Date
December 1 2014
End Date
October 1 2018
Last Update
January 6 2015
Active Locations (1)
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1
King Fahad Medical City
Riyadh, Riyadh Region, Saudi Arabia, 11525