Synergistic APProach of continuous Fludarabine, Cytarabine and etoposIde for RElapsed or refractory acute myeloid leukemia
- Conditions
- Neoplasms
- Registration Number
- KCT0003694
- Lead Sponsor
- Gachon University Gil Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 75
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.)
- 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The efficacy of etoposide, continuous, and fludarabin as the secondary chemotherapy for relapsed/refractory acute myeloblastic leukemia
- Secondary Outcome Measures
Name Time Method 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