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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azacytidine | Drug |
|
| |
| Fludarabine |
| Measure | Description | Time Frame |
|---|---|---|
| complete response rate | bone marrow blast <5% with complete neutrophil (>1000/ul) and platelets (>100,000/ul) recovery | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| leukemia free survival | from time of complete remission to time of relapse or death | 1-3 years |
| overall survival | from date of enrolment to date of death |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ibraheem H Motabi, MD | Contact | +966 11 288 9999 | 11998 | imotabi@kfmc.med.sa |
| Humariya H Munshi | Contact | +966 11 288 9999 | 14029 | hmunshi@kfmc.med.sa |
| Name | Affiliation | Role |
|---|---|---|
| Ibraheem H Motabi, MD | King Fahad Medical City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Fahad Medical City | Recruiting | Riyadh | Riyadh Region | 11525 | Saudi Arabia |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| C024352 | fludarabine |
| D003561 | Cytarabine |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Drug |
|
| Cytarabine | Drug |
|
| Filgrastim | Drug | G-CSF |
|
| 1-3 yeears |
| one year leukemia free survival | probability of leukemia free survival at one year of enrolment | 1 year |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D001087 | Arabinonucleosides |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |