ISRCTN34016918进行中（未招募）2 期
OPTIMISE-FLT3 - optimising therapy in FLT3-mutated acute myeloid leukaemia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 390
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of AML
- •2. Age =16 years (no specified upper age limit)
- •3. Considered fit for intensive AML therapy by the treating physician
- •4. Confirmed FLT3 ITD or TKD mutation (or FLT3 status unknown but requires urgent therapy - see below*)
- •5. Serum creatinine less than or equal to 1.5 x ULN (upper limit of normal)
- •6. Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to 2.5 x ULN and bilirubin less than or equal to 2 x ULN
- •7. A negative pregnancy test within 2 weeks prior to trial entry in WOCBP (to be repeated throughout the trial prior to each course of protocol treatment)
- •8. Sexually mature males and females must agree to use an adequate and medically accepted method of contraception throughout the study and for 6 months following treatment if they or their sexual partners are women of childbearing potential (WOCBP)
- •9. WHO performance status 0-2
- •10. Written informed consent
- •*FLT3-mutated AML is associated with proliferative disease features such as hyperleukocytosis (high white blood cell count) and may present as a medical emergency. It is important that the full clinical spectrum of FLT3-mutated AML is represented in Optimise-FLT3, including hyper-proliferative cases. Should the treating physician feel that the safety of an individual patient could be compromised by delaying therapy while awaiting FLT3 genotyping, they may, on discussion with the study team, proceed with study entry (using PIS2), randomisation and treatment provided all other eligibility criteria are met. Any patients who enter the trial and are subsequently found to have wild-type FLT3 will be considered evaluable for safety/toxicity analysis but will be replaced with additional FLT3-mutated cases to maintain statistical power for the clinical efficacy endpoints and equipoise between arms.
排除标准
- •1. Receipt of any previous therapy for AML or any antecedent haematological condition (the use of oral hydroxycarbamide to control white blood cell count is permitted)
- •2. Other active malignancy requiring treatment
- •3. Patients who are pregnant or lactating
- •4. Uncontrolled infection with Human Immunodeficiency Virus (HIV) or Hepatitis B or C. Patients with known chronic infections who are receiving or have completed therapy and have recent documented negative viral PCR tests are not excluded
- •5. Blast transformation of chronic myeloid leukaemia (CML)
研究者
相似试验
尚未招募
不适用
Intensity-adjusted SAlvage chemotheraPy Plus FLT3-inHibitor Gilteritinib In RElapsed/refractory acute myeloid leukemia with mutated FLT3-ITD/TKDDiseases of the blood and blood-forming organs and certain disorders involving the immune mechanismKCT0006222Gachon University Gil Medical Center26
招募中
1 期
A phase 3b, interventional, adaptive, clinical trial to evaluate the efficacy and safety of tralokinumab 300 mg every second week monotherapy compared with placebo in subjects with moderate-to-severe atopic hand eczema who are candidates for systemic therapy (ADHAND)Atopic dermatitis and moderate-to severe atopic hand eczemaMedDRA version: 21.1Level: LLTClassification code: 10003639Term: Atopic dermatitis Class: 10040785MedDRA version: 21.1Level: LLTClassification code: 10003641Term: Atopic eczema Class: 10040785CTIS2022-502653-34-01EO PHARMA A/S402
进行中（未招募）
3 期
A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive ChemotherapyMyelodysplastic Syndrome With Excess Blasts-2Acute Myeloid LeukemiaNCT04027309Stichting Hemato-Oncologie voor Volwassenen Nederland777
进行中（未招募）
1 期
FOLFOXIRI plus Panitumumab or FOLFOX plus Panitumumab in the treatment of metastatic colorectal cancer.Metastatic Colorectal CancerMedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864EUCTR2016-004394-40-ITFondazione GONO432
已完成
3 期
flt3L in Treating Patients With Acute Myeloid LeukemiaLeukemiaNCT00006223Eastern Cooperative Oncology Group