EUCTR2017-001600-29-ES进行中（未招募）1 期
Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects = 75 Years of Age with Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 322
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
入选标准
- •1. Confirmed diagnosis of AML according to WHO 2016 classification
- •2. Presence of FLT3-ITD and/or D835 mutation(s)
- •3. Subjects must be primary refractory or relapsed to 1st line intensive treatment for AML or refractory or relapsed after second line of treatment for AML as defined by:
- •3a. Primary refractory is defined as no CR or CRi after two courses of intensive induction chemotherapy.
- •3b. Relapse after first line treatment for AML is defined as the first hematologic relapse after one line of treatment for AML that includes at least one course of intensive chemotherapy with or without a tyrosine kinase inhibitor.
- •3c. Relapse after second line treatment for AML is defined as a hematologic relapse after two lines of treatment for AML. Subjects may be refractory to or relapse after the first line treatment but must have achieved a CR/CRi after second line treatment and subsequently relapse. First line treatment must include at least one course of intensive chemotherapy. Second line treatment may be one of the following:
- •i. Intensive or non-intensive salvage therapy with or without tyrosine kinase inhibitor or other targeted therapy
- •ii. Tyrosine kinase inhibitor alone
- •iii. Hypomethylating agent
- •iv. One experimental therapy for treatment of AML
- •3d. Refractory after second line treatment for AML is defined as no CR or CRi after second line of treatment for AML. Subjects who are refractory after a second line treatment for AML must have must have achieved a CR/CRi after first line treatment and subsequently relapsed. First line treatment must include at least one course of intensive chemotherapy. Second line treatment may be one of the following:
- •i. Non-intensive salvage therapy with or without tyrosine kinase inhibitor or other targeted therapy
- •ii. Tyrosine kinase inhibitor alone
- •iii. Hypomethylating agent
- •iv. One experimental therapy for treatment of AML
- •4. Eligible for pre-selected induction chemotherapy specified in the protocol
- •5. Age = 18 years and = 75 years
- •6. Adequate hepatic function
- •7. Adequate renal functions
- •8. ECOG performance status = 3
- •9. Female subjects with reproductive potential must have negative serum or urine pregnancy test.
- •10. Adequate contraception, if heterosexually active
- •11. Written informed consent before any study-specific procedure is performed
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 122
排除标准
- •1. Subjects with any of the following current or previous diagnoses:
- •Treatment related AML secondary to prior chemotherapy
- •AML secondary to prior myelodysplastic syndrome (MDS)
- •AML secondary to prior myeloproliferative syndrome (MPN) including polycythemia vera, essential thrombocythemia, myelofibrosis, mastocytosis and chronic myeloid leukemia
- •Acute promyelocytic leukemia (APL)
- •AML secondary to MDS/MPN syndromes including chronic myelomonocytic leukemia
- •DNA fragility or bone marrow failure syndromes
- •Blastic plasmacytoid dendritic cell neoplasm
- •Acute leukemia of ambiguous lineage
- •B-lymphoblastic leukemia/lymphoma
- •T-lymphoblastic leukemia/lymphoma, including early T-cell precursor lymphoblastic leukemia (ETP-ALL)
- •2. Known clinically active central nervous system (CNS) leukemia
- •3. Subjects who have received more than 1 prior allogeneic HSCT.
- •4. Subjects who are refractory to first-line (induction and re-induction) and a second-line (1st salvage) treatment for AML.
- •5. Severe liver disease
- •6. Active infections including known mycobacterial infections. Subjects with positive blood cultures for virus, bacteria, or fungi, or sepsis will not be eligible.
- •7. Inadequate pulmonary function (subjects requiring assisted ventilation will not be eligible)
- •8. Hemodynamically unstable (subjects requiring pressor support will not be eligible)
- •9. Active infection with hepatitis B virus (HBV), defined as a positive test for HBV surface antigen (HBsAg), and/or active infection with hepatitis C virus (HCV), defined as a positive test for HCV ribonucleic acid (RNA)
- •10. Clinically significant bleeding diathesis and coagulation disorder independent of leukemia
- •11. Subjects with a currently active” second malignancy other than non-melanoma skin cancers.
- •12. Inadequate cardiac function, including greater than Grade 2 decreased ejection fraction, clinically significant prolonged QTc interval, congestive heart failure class III or IV by the NYHA, unstable angina (angina symptoms at rest), new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
- •13. Any disorder that compromises the subject’s ability to give written informed consent and/or to comply with study procedures
- •14. Any substance abuse, severe and/or uncontrolled medical, social or psychiatric conditions that may prevent the subject from completing the study, interfere with the evaluation of safety and/or efficacy, or interfere with the interpretation of the study results
- •15. Grade 2 or above graft-versus-host disease (GvHD), including acute, chronic, or overlap; or escalation of therapy for GvHD within 14 days prior to randomization
- •16. Major surgical procedures within the 28 days prior to randomization (does not include line placement as needed for chemotherapy administration).
- •17. Prior anti-leukemia therapy within the 14 days prior to randomization. Prior use of quizartinib or gilteritinib must be discontinued 21 days prior to randomization. Prior use of hydroxyurea or other palliative treatment for leukocytosis is
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