Azacytidine Plus FLAG for Relapsed or Refractory AML

King Fahad Medical City

Status and phase: Unknown; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Cytarabine; Drug: Fludarabine; Drug: Filgrastim; Drug: Azacytidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02275663

KFMC-AML01

Details and patient eligibility

About

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.

Enrollment: 37 estimated patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Azacytidine plus FLAG

Experimental group

Description:

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.

Treatment:

Drug: Azacytidine

Drug: Filgrastim

Drug: Cytarabine

Drug: Fludarabine