Azacytidine Plus FLAG for Relapsed or Refractory AML
Phase 2 Study of 5 Days Azacytidine Priming Prior to Fludarabine, Cytarabine and Granulocyte-Colony Stimulating Factor (G-CSF) Combination for Patients With Relapsed or Refractory AML
1 other identifier
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2014
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2014
CompletedFirst Posted
Study publicly available on registry
October 27, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedJanuary 6, 2015
January 1, 2015
2.8 years
October 20, 2014
January 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
complete response rate
bone marrow blast \<5% with complete neutrophil (\>1000/ul) and platelets (\>100,000/ul) recovery
6 weeks
Secondary Outcomes (3)
leukemia free survival
1-3 years
overall survival
1-3 yeears
one year leukemia free survival
1 year
Study Arms (1)
Azacytidine plus FLAG
EXPERIMENTALAzacytidine 75 mg/m2 = mg IV in 100 ml Normal Saline (NS) over 30 minutes on days -5 t0 -1 G-CSF 5 mcg/kg subcut on days 0 to + 6 Fludarabine 30mg/m² in 100ml NS IV daily over 30min., on Days +1 to +5 Cytarabine 2gm/m² = 500ml NS IV daily over 4h, on Days +1 to +5 Start 4h after completion of fludarabine infusion.
Interventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Fahad Medical City
Riyadh, Riyadh Region, 11525, Saudi Arabia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ibraheem H Motabi, MD
King Fahad Medical City
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant, Hematology and BMT
Study Record Dates
First Submitted
October 20, 2014
First Posted
October 27, 2014
Study Start
December 1, 2014
Primary Completion
October 1, 2017
Study Completion
October 1, 2018
Last Updated
January 6, 2015
Record last verified: 2015-01