VICTOR: Venetoclax or Intensive Chemotherapy for Treatment Of Favourable Risk Acute Myeloid Leukaemia: a molecularly guided phase 2 study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Molecular event-free survival time (mEFS). An event is defined as follows: a) Failure to achieve morphological CR or CRi after two cycles of therapy, b) Molecular persistence, progression or relapse requiring treatment change (at any time), c) Morphological relapse (at any time) or d) Death (at any time)
研究概览
简要总结
To compare molecular event free survival (mEFS) in AML patients receiving venetoclax and low dose cytarabine with those receiving intensive chemotherapy. mEFS is defined as; 1.Failure to achieve complete remission or complete remission with incomplete blood count recovery after two cycles of treatment 2.Molecular persistence (not responding to treatment), progression or relapse requiring treatment change 3.Morphological Relapse 4.Death
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CD33 positive Acute Myeloid Leukaemia
- •Age ≥55 years
- •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
排除标准
- •Previous chemotherapy for AML or any antecedent 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 7 months after treatment
- •Unable to swallow tablets whole
- •Known hypersensitivity to any of the IMPs
- •Patients known to require vaccination with a live vaccine during the treatment period
结局指标
主要结局
Molecular event-free survival time (mEFS). An event is defined as follows: a) Failure to achieve morphological CR or CRi after two cycles of therapy, b) Molecular persistence, progression or relapse requiring treatment change (at any time), c) Morphological relapse (at any time) or d) Death (at any time)
Molecular event-free survival time (mEFS). An event is defined as follows: a) Failure to achieve morphological CR or CRi after two cycles of therapy, b) Molecular persistence, progression or relapse requiring treatment change (at any time), c) Morphological relapse (at any time) or d) Death (at any time)
次要结局
- Occurrence of morphological complete remission (CR or CRi) by the end of the second cycle of treatment (see protocol section 8.14 for definitions of morphological response)
- Death within 30 and 60 days from trial entry
- Overall survival time
- Time to morphological relapse (see protocol section 8.14 for definitions of morphological response)
- Time to molecular relapse (see protocol section 8.14 for definitions of molecular response)
- Cumulative occurrence of grade 3 and 4 adverse events at 12 and 24 months
- Prevalence of molecular complete remission at month 3, 6 and 12
- Cumulative resource use at 12 and 24 months including hospital admission days, blood product usage and days on intravenous antibiotics and antifungals
- Health-related quality of life at month 3, 6, 12, 18 and 24
- Change in performance status from baseline at month 3, 6, 12, 18 and 24
- Change in Comprehensive Geriatric Assessment (CGA) from baseline at month 12 and 24
研究者
Clinical Trial Coordinator
Scientific
The University Of Birmingham