2024-516116-19-00RecruitingPhase 2
VICTOR: Venetoclax or Intensive Chemotherapy for Treatment Of Favourable Risk Acute Myeloid Leukaemia: a molecularly guided phase 2 study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 9 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 7 Oct 2024
- Start date
- 1 Jan 2025
- Lead sponsor
- The University Of Birmingham
- Diseases
- Acute myeloid leukemia
- EU CT number
- 2024-516116-19-00
- EudraCT number
- 2020-000273-24
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 10
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- 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
Lab values
- Previous chemotherapy for AML or any antecedent haematological condition, with the exception of hydroxycarbamide to control white blood cell count
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus Universitetshospital | Aarhus N | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.