Clinical trial · Interventional
Azacytidine Plus FLAG for Relapsed or Refractory AML
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
NCT02275663CI-TRIAL-00016525unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacytidine | Drug | Azacitidine | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Filgrastim | Drug | Filgrastim | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Azacytidine plus FLAG
- description
- 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.
- interventionNames
- Drug: Azacytidine
- Drug: Fludarabine
- Drug: Cytarabine
- Drug: Filgrastim
Primary outcomes (1)
- measure
- complete response rate
- timeFrame
- 6 weeks
- description
- bone marrow blast \<5% with complete neutrophil (\>1000/ul) and platelets (\>100,000/ul) recovery
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.