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VICTOR: Venetoclax or Intensive Chemotherapy for Treatment Of Favourable Risk Acute Myeloid Leukaemia: a molecularly guided phase 2 study
EU CTIS ID: 2024-516116-19-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.