None listed
Conditions
Interventions
Drug : ? Remission induction therapy consists of fludarabine/cytarabine, etoposide, and granulocyte-colony stimulating factor (G-CSF) (CE-FLAG-I) performed through continuous intravenous infusion.
Adm
Sponsors
Gachon University Gil Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - R/R AML to receive salvage therapy as the secondary chemotherapy - Those who did not achieve CR after the primary induction chemotherapy for the newly diagnosed, therapy naïve AML (if re-induction therapy is performed according to the preliminary plan for primary induction chemotherapy, it is considered that the first-line therapy is performed only.) - Those who achieved the first CR after the primary induction chemotherapy for a newly diagnosed, therapy naïve AML and relapsed for the first time (if consolidation therapy is performed without a relapse, it is considered that the first-line therapy is performed only.) - Cases in which HCT is performed after first CR and relapsed, yet other chemotherapies were not performed - Aged 18 years and over - Obtaining the informed consent with signature and dates - ECOG<3 - Healthy liver and kidneys (AST, ALT, bilirubin, and creatinine levels below the normal upper limit by 2.5 times). A rise in the AST or ALT levels caused by the infiltration of leukemic cells into the liver is allowed. - Healthy heart (heart scanning or echocardiography shows over 45% of left ventricular ejection fraction.)
Exclusion criteria
Exclusion criteria: - Acute leukemia or leukemia accompanied by t(15;17) or PML/RAR gene arrangement - Invasion of leukemia into the central nervous system - Extramedullary granulocytic sarcoma without invasion into the bone marrow - Patients who’ve received treatment for leukemia more than twice; excluding those who were administered with hydroxyurea to reduce the number of leukemic cells prior to remission induction therapy and received consolidation therapy/HCT without a relapse after first CR - Severe active infections - Uncontrollable bleeding - Patients with severe bone marrow depression - Patients who were hypersensitive to etoposide and etoposide components - Patients with renal failure showing serum creatinine clearance <30ml/min - Breastfeeding and pregnant women and fertile women who refuse contraception - Those who are free from diseases in less than five years after radical treatment for other cancers (excluding nonmelanoma skin cancer, intraepithelial carcinoma, and cervical intraepithelial neoplasia radically removed) - Those who experienced severe cardiovascular disorders including cardiac infarction in the last six months - Those with major accompanying diseases or organ failure - Those who have ever been administered with fludarabine to treat AML (not applicable to those administered with it for the pre-treatment of HCT) - Patients difficult to comply with treatment due to Psychiatric or cognitive problems - Patients hypersensitive to granulocyte colony stimulating factor drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of etoposide, continuous, and fludarabin as the secondary chemotherapy for relapsed/refractory acute myeloblastic leukemia | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation basically uses common terminology criteria for adverse event version 4.03; and treatment-related mortality, 100-day mortality, and survival rates are used as items for secondary safety evaluation | — |
Countries
Korea, Republic of
Contacts
Public ContactSinhye Jang
Gachon University Gil Medical Center
Outcome results
None listed