Venetoclax or Intensive Chemotherapy for Treatment Of favourable Risk acute myeloid leukaemia: a molecularly guided phase 2 study

niversity of Birmingham0 个研究点目标入组 156 人开始时间: 2020年12月8日最近更新: 2024年7月8日

适应症

试验速览

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36376888/ (added 23/11/2022)

•Current inclusion criteria as of 09/02/2024:
•1. Diagnosis of CD33-positive acute myeloid leukaemia
•2. Age >=55 years (prior to the interim analyses performed after enrolment of 50 and 100 patients)
•3. Genotype NPM1mut FLT3 ITDneg (FLT3- Tyrosine Kinase Domain mutation, TKD, is permitted)
•4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
•5. Serum creatinine <=1.5 x ULN (upper limit of normal)
•6. Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) <=2.5 ULN and bilirubin <=2 x ULN
•7. Able to provide written informed consent
•8. Considered fit for intensive chemotherapy with anthracyclines by treating physician
•Previous inclusion criteria:
•1. Diagnosis of CD33-positive acute myeloid leukaemia
•2. Age >=60 years (prior to the interim analyses performed after enrolment of 50 and 100 patients)
•3. Genotype NPM1mut FLT3 ITDneg (FLT3- Tyrosine Kinase Domain mutation, TKD, is permitted)
•4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
•5. Serum creatinine <=1.5 x ULN (upper limit of normal)
•6. Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) <=2.5 ULN and bilirubin <=2 x ULN
•7. Able to provide written informed consent
•8. Considered fit for intensive chemotherapy with anthracyclines by treating physician

•1. Previous chemotherapy for AML or any antedecent haematological condition, with the exception of hydroxycarbamide to control white blood cell count
•2. Other active malignancy requiring treatment
•3. 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
•4. Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry)
•5. Females of childbearing potential, and their partners, not willing to use adequate contraception during and for up to 6 months after treatment
•6. Unable to swallow tablets whole
•7. Known hypersensitivity to any of the IMPs
•8. Patients known to require vaccination with a live vaccine during the treatment period

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