Azacytidine Plus FLAG for Relapsed or Refractory AML

Sponsor

King Fahad Medical City (Other)

Overall Status

Unknown status

CT.gov ID

NCT02275663

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: Azacytidine Drug: Fludarabine Drug: Cytarabine Drug: Filgrastim	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

37 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

Oct 1, 2017

Anticipated Study Completion Date :

Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Azacytidine plus FLAG Azacytidine 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.	Drug: Azacytidine Other Names: vidaza Drug: Fludarabine Drug: Cytarabine Drug: Filgrastim G-CSF

Arm

Intervention/Treatment

Experimental: Azacytidine plus FLAG

Azacytidine 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.

Drug: Azacytidine

Other Names:

vidaza

Drug: Fludarabine

Drug: Cytarabine

Drug: Filgrastim

G-CSF

Outcome Measures

Primary Outcome Measures

complete response rate [6 weeks]
bone marrow blast <5% with complete neutrophil (>1000/ul) and platelets (>100,000/ul) recovery

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.