Acute Myeloid LeukemiaPhase 2NCT02275663
Azacytidine Plus FLAG for Relapsed or Refractory AML
A Phase 2 study testing Azacytidine, Fludarabine and Cytarabine in people with Acute Myeloid Leukemia, run by King Fahad Medical City at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Azacytidine, Fludarabine and Cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Dec 2014to Oct 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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%
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Fahad Medical City
Riyadh, Riyadh Region, 11525
Ibraheem Motabi, MD, +966112889999 ext. 11998, imotabi@kfmc.med.sa
About this study
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
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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Azacytidine, Fludarabine, Cytarabine, Filgrastim
- Keywords
- relapsed AML, refractory AML, azacytidine
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacytidineDrug
Also called vidaza
FludarabineDrug
CytarabineDrug
FilgrastimDrug
G-CSF
| Study group | Role | What they receive |
|---|---|---|
| Azacytidine plus FLAG | Experimental | 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. Receives: Drug: Azacytidine; Drug: Fludarabine; Drug: Cytarabine; Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response rate
bone marrow blast <5% with complete neutrophil (>1000/ul) and platelets (>100,000/ul) recovery
Measured: 6 weeks
Secondary outcomes (3)
leukemia free survival
from time of complete remission to time of relapse or death
Measured: 1-3 years
overall survival
from date of enrolment to date of death
Measured: 1-3 yeears
one year leukemia free survival
probability of leukemia free survival at one year of enrolment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2017 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Fahad Medical City
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ibraheem Motabi, King Fahad Medical City
- Investigators
- Ibraheem H Motabi, MD, Principal investigator, King Fahad Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275663
- Sponsor's protocol ID
- KFMC-AML01
- Status last verified
- Jan 2015
- First submitted
- 20 Oct 2014
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02275663
- Acronym / sponsor ID
- KFMC-AML01
- Conditions
- Acute Myeloid Leukemia
- Keywords
- relapsed AML, refractory AML, azacytidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- King Fahad Medical CityOther government
- Study start
- Dec 2014
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azacytidine plus FLAG | Experimental | Drug: Azacytidine, Drug: Fludarabine, Drug: Cytarabine, Drug: FilgrastimAzacytidine 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. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzacytidineAlso: vidaza | Drug | Azacytidine plus FLAG |
| Fludarabine | Drug | Azacytidine plus FLAG |
| Cytarabine | Drug | Azacytidine plus FLAG |
| FilgrastimG-CSF | Drug | Azacytidine plus FLAG |
Primary outcome
complete response rate
Time frame: 6 weeks
bone marrow blast <5% with complete neutrophil (>1000/ul) and platelets (>100,000/ul) recovery
3 secondary outcomes
leukemia free survival
Time frame: 1-3 years
overall survival
Time frame: 1-3 yeears
one year leukemia free survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ibraheem H Motabi, MD principal investigator
King Fahad Medical City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azacytidine, Fludarabine and Cytarabine in people with Acute Myeloid Leukemia, run by King Fahad Medical City at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ibraheem H Motabi, MD (+966 11 288 9999 ext. 11998, imotabi@kfmc.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response rate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.