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Taking people in DenmarkPhase 2

Compares venetoclax with intensive chemotherapy for favourable risk acute myeloid leukaemia

Compares two treatments in adults with a type of acute myeloid leukaemia.

Key facts

Who runs it
The University Of Birmingham
Where
Aarhus N, DenmarkSee the site
Registry title
VICTOR: Venetoclax or Intensive Chemotherapy for Treatment Of Favourable Risk Acute Myeloid Leukaemia: a molecularly guided phase 2 study
Status
Recruiting
Phase
Phase 2
People taking part
10 people, planned
Started
1 Jan 2025
Expected to end
1 Jun 2029
Type of study
Interventional
Record updated
9 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 55 or older with newly diagnosed acute myeloid leukaemia (AML) with a specific gene profile, who are fit for intensive chemotherapy.

Age
55 years or older
Sex
All sexes can join.
Disease stage
CD33 positive acute myeloid leukaemia (AML). Daily activity level (ECOG) 0-2.
Earlier treatment
No earlier chemotherapy for AML or any earlier blood condition. Hydroxycarbamide to control white blood cell count is allowed. Must be fit for intensive chemotherapy with anthracyclines, as judged by the treating doctor.
Biomarker or test result
NPM1 mutation present and FLT3 ITD absent. A FLT3 tyrosine kinase domain (TKD) mutation is allowed.

Main reasons for not taking part

  • Another active cancer that needs treatment
  • Newly diagnosed or uncontrolled HIV, hepatitis B or hepatitis C infection
  • Pregnant or breastfeeding
  • Cannot swallow tablets whole
  • Known allergy to any of the trial drugs

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Denmark

  • Aarhus UniversitetshospitalAarhus N, DenmarkTaking people

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
VICTOR: Venetoclax or Intensive Chemotherapy for Treatment Of Favourable Risk Acute Myeloid Leukaemia: a molecularly guided phase 2 study
Plain-language title
Compares venetoclax with intensive chemotherapy for favourable risk acute myeloid leukaemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
9 April 2026