Azacytidine Plus FLAG for Relapsed or Refractory AML

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02275663
• Other study ID #: KFMC-AML01
• Status: Recruiting
• Phase: Phase 2
• First received: October 20, 2014
• Last updated: January 4, 2015
• Start date: December 2014
• Est. completion date: October 2018

Study information

• Verified date: January 2015
• Source: King Fahad Medical City
• Contact: Ibraheem H Motabi, MD
• Phone: +966 11 288 9999
• Email: imotabi[@]kfmc.med.sa
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: October 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Azacytidine

• Fludarabine

• Cytarabine

• Filgrastim
G-CSF

Locations

Country	Name	City	State
Saudi Arabia	King Fahad Medical City	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Fahad Medical City

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete response rate	bone marrow blast <5% with complete neutrophil (>1000/ul) and platelets (>100,000/ul) recovery	6 weeks	No
Secondary	leukemia free survival	from time of complete remission to time of relapse or death	1-3 years	No
Secondary	overall survival	from date of enrolment to date of death	1-3 yeears	No
Secondary	one year leukemia free survival	probability of leukemia free survival at one year of enrolment	1 year	No