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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02275663

Enrollment

Registered

2014-10-27

Start date

2014-12-31

Completion date

2018-10-31

Last updated

2015-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

relapsed AML, refractory AML, azacytidine

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.

Interventions

DRUGAzacytidine

DRUGFludarabine

DRUGCytarabine

DRUGFilgrastim

G-CSF

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 60 Years

Healthy volunteers

Inclusion criteria

1. Age 16 to 60 2. Patients with a diagnosis of relapse or refractory AML (≥ 20% blast in bone marrow). 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 4. 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 criteria

1. Patients with a diagnosis of acute promyelocytic leukemia (AML -M3) 2. Pregnant women 3. Patients previously treated with fludarabine are allowed to participate. 4. 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.

Design outcomes

Primary

Measure	Time frame	Description
complete response rate	6 weeks	bone marrow blast \<5% with complete neutrophil (\>1000/ul) and platelets (\>100,000/ul) recovery

Secondary

Measure	Time frame	Description
leukemia free survival	1-3 years	from time of complete remission to time of relapse or death
overall survival	1-3 yeears	from date of enrolment to date of death
one year leukemia free survival	1 year	probability of leukemia free survival at one year of enrolment

Countries

Saudi Arabia

Contacts

Primary ContactIbraheem H Motabi, MD

imotabi@kfmc.med.sa+966 11 288 9999

Backup ContactHumariya H Munshi

hmunshi@kfmc.med.sa+966 11 288 9999

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026