VICTOR: Venetoclax or Intensive Chemotherapy for Treatment Of Favourable Risk Acute Myeloid Leukaemia: a molecularly guided phase 2 study
Key facts
- Where
- Aarhus N, DániaSee the site
- Phase
- 2. fázis
Where in Dánia
- Aarhus UniversitetshospitalAarhus N, DániaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The University Of Birmingham
- Trial code
- EU 2024-516116-19-00
- Record updated
- 2026. április 9.
- Original description
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.DeathRead full original descriptionShow less
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
Inclusion: 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.
Exclusion: Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry); Patients known to require vaccination with a live vaccine during the treatment period; 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; Known hypersensitivity to any of the IMPs; Previous chemotherapy for AML or any antecedent haematological condition, with the exception of hydroxycarbamide to control white blood cell count; 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.