Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
37 participants
INTERVENTIONAL
2014-12-31
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Azacytidine
Fludarabine
Cytarabine
Filgrastim
G-CSF
Interventions
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Azacytidine
Fludarabine
Cytarabine
Filgrastim
G-CSF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
16 Years
60 Years
ALL
No
Sponsors
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King Fahad Medical City
OTHER_GOV
Responsible Party
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Ibraheem Motabi
Consultant, Hematology and BMT
Principal Investigators
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Ibraheem H Motabi, MD
Role: PRINCIPAL_INVESTIGATOR
King Fahad Medical City
Locations
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King Fahad Medical City
Riyadh, Riyadh Region, Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KFMC-AML01
Identifier Type: -
Identifier Source: org_study_id
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