Venetoclax or Intensive Chemotherapy for Treatment Of Favourable Risk Acute Myeloid Leukaemia: A Molecularly Guided Phase 2 Study - VICTOR

niversity of Birmingham0 个研究点目标入组 186 人开始时间: 2020年8月21日最近更新: 2020年11月16日

适应症

试验速览

暂无简介。

•Diagnosis of CD33 positive Acute Myeloid Leukaemia
•Age =60 years (prior to the interim analyses performed after enrolment of 50 and 100 patients)
•Genotype NPM1mut FLT3 ITDneg (FLT3- Tyrosine Kinase Domain mutation, TKD, is permitted)
•Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•Serum creatinine = 1.5 x ULN (upper limit of normal)
•Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) = 2.5 ULN and bilirubin = 2 x ULN
•Able to provide written informed consent
•Considered fit for intensive chemotherapy with anthracyclines by treating physician
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 46
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 140

•Previous chemotherapy for AML or any antedecent haematological condition, with the exception of hydroxycarbamide to control white blood cell count
•Other active malignancy requiring treatment
•Newly diagnosed or uncontrolled HIV or hepatitis B or C infection. Patients with known chronic infections may enrol if the last two tests for viral load have been negative and their current therapy does not include a protease inhibitor or a non-nucleoside reverse-transcriptase inhibitor
•Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry)
•Females of childbearing potential, and their partners, not willing to use adequate contraception during and for up to 6 months after treatment
•Unable to swallow tablets whole

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