EUCTR2013-004890-28-PL进行中（未招募）1 期
A Phase 3 Open-Label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects with FLT3-ITD Positive Acute Myeloid Leukemia (AML) Refractory To or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 367
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria
- •To be able to participate in this study, candidates must meet the following criteria at screening
- •or other specified time point:
- •1. Provision of written informed consent approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) with privacy language in accordance with national regulations (eg, HIPAA authorization for US sites) prior to any study-related procedures, including withdrawal of prohibited medications if applicable.
- •2. Age =18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.
- •3. Morphologically documented primary AML or AML secondary to myelodysplastic syndrome (MDS), as defined by World Health Organization criteria, as determined by pathology review at the study site.
- •4. In first relapse (with duration of remission of 6 months or less) or refractory after prior therapy, with or without HSCT. Induction therapy must have included at least 1 cycle of an anthracycline/mitoxantrone containing induction block at a standard dose.
- •Refractory is defined as:
- •- After 1 cycle, a reduction in bone marrow blasts of less than 50% and failure to achieve a CR, CRp, or CRi.
- •- After 2 cycles, lack of achievement of CR, CRp, or CRi
- •First relapse (with duration of remission of 6 months or less) is defined as:
- •- Achievement of CR, CRi, or CRp, as defined by 2003 International Working
- •Group criteria after initial AML therapy with or without consolidation or
- •maintenance, and with or without HSCT.
- •- Duration of CR, CRi or CRp is measured from the date of the bone marrow
- •assessment which confirmed response or the date of allogeneic transplantation to the date of the bone marrow assessment that identified relapse or the appearance of peripheral blasts.
- •5. Presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood (allelic ratio as determined by a central laboratory with a cutoff of =3% FLT3-ITD/total FLT3). If a specimen has been sent for FLT3-ITD testing at the central laboratory but the subject requires treatment for AML before the central FLT3-ITD test result is available, a local test result may be acceptable for randomization after consultation with the Medical Monitor.
- •6. Eligibility for pre-selected salvage chemotherapy, according to the Investigator’s assessment.
- •7. ECOG performance score 0-2.
- •8. Discontinuation of prior AML treatment before the start of study treatment (except hydroxyurea or other treatment to control leukocytosis) for at least 2 weeks for cytotoxic agents, or for at least 5 half-lives for non-cytotoxic agents.
- •9. Serum creatinine =1.5×upper limit of normal (ULN), or glomerular filtration rate >25 mL/min, as calculated with the Cockcroft-Gault formula.
- •10. Serum potassium, magnesium, and calcium (serum calcium corrected for
- •hypoalbuminemia) within institutional normal limits. Subjects with electrolytes outside the normal range will be eligible if these values are corrected upon retesting following any necessary supplementation.
- •11. Total serum bilirubin =1.5×ULN.
- •12. Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) =2.5×ULN.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 273
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1. Acute promyelocytic leukemia (AML subtype M3).
- •2. AML secondary to prior chemotherapy for other neoplasms, except AML secondary to prior MDS.
- •3. History of another malignancy, unless the candidate has been disease-free for at least 5 years.
- •Candidates with treated non-melanoma skin cancer, carcinoma in situ, or cervical intraepithelial neoplasia are eligible regardless of the time spent disease-free, if they have completed definitive treatment.
- •Candidates with organ-confined prostate cancer, with no evidence of recurrent or progressive disease, are eligible if hormonal therapy has been begun, or if the tumor has been surgically removed or treated with definitive radiotherapy
- •4. Persistent, clinically significant > Grade 1 non-hematologic toxicity from prior AML therapy.
- •5. Clinically significant GVHD or GVHD requiring initiation of treatment or treatment escalation within 21 days, and/or > Grade 1 persistent or clinically significant non-hematologic toxicity related to HSCT.
- •6. History of or current, central nervous system involvement with AML.
- •7. Clinically significant coagulation abnormality, such as disseminated intravascular coagulation.
- •8. Prior treatment with quizartinib or participated in a prior quizartinib study.
- •9. Prior treatment with a FLT3 targeted therapy including sorafenib or investigational FLT3 inhibitors (not including the multi-kinase inhibitor, midostaurin).
- •10. Major surgery within 4 weeks prior to screening.
- •11. Radiation therapy within 4 weeks prior to screening.
- •12. Uncontrolled or significant cardiovascular disease, including:
- •QTcF interval >450 msec (average of triplicate determinations).
- •Subject has bradycardia of less than 50 BPM (as determined by central reading) unless the subject has a pacemaker.
- •Diagnosed or suspected long QT syndrome, or known family history of long QT syndrome.
- •History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes.
- •History of second or third degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers, and have no history of fainting or clinically relevant arrhythmia with pacemakers.
- •Myocardial infarction within 6 months prior to screening.
- •Uncontrolled angina pectoris within 6 months prior to screening.
- •New York Heart Association (NYHA) Class 3 or 4 congestive heart failure.
- •Left ventricular ejection fraction (LVEF) =45 % or institutional lower limit of normal.
- •Uncontrolled hypertension.
- •Complete left or right bundle branch block.
- •13. Active infection not well controlled by antibacterial, antifungal, and/or antiviral therapy.
- •14. Known infection with human immunodeficiency virus, or active hepatitis B or C, or other active clinically relevant liver disease.
- •15. Unwillingness to receive infusion of blood products according to the protocol.
- •16. In a man whose sexual partner is a woman of childbearing potential, unwillingness or inability of the man or woman to use a highly effective contraceptive method for the entire study treatment period and for at least 3 months after study treatment completion.
- •Male subjects must not freeze or donate sperm starting at Screening and throughout the study period and 105 days after the final study drug administration.
- •17. In a heterosexually active woman of childbearing potential, unwillingness or inability to use a highly effective contraceptive method for the entire study treatment period
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