Azacytidine Plus FLAG for Relapsed or Refractory AML

January 4, 2015 updated by: Ibraheem Motabi, King Fahad Medical City

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11525
        • Recruiting
        • King Fahad Medical City
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Fludarabine
Drug: Cytarabine
Drug: Azacytidine
Other Names:
  • vidaza
Drug: Filgrastim
G-CSF

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Fahad Medical City

Investigators

  • Principal Investigator: Ibraheem H Motabi, MD, King Fahad Medical City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 4, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFMC-AML01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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