Vyxeos for Induction of Low- or Intermediate-risk.
Status:
Recruiting
Trial end date:
2027-03-01
Target enrollment:
Participant gender:
Summary
Vyxeos Vyxeos is a liposomal-encapsulated combination of cytarabine and daunorubicin, at a
molar ratio of 5:1. Delivery of the 5:1 molar ratio seems to prevent antagonistic drug-drug
interactions and the liposomal encapsulation increases the plasma half-life of cytarabine and
daunorubicin and leads to drug accumulation within the bone marrow (BM).
Despite previous results that highlighted the advantage of Vyxeos for sAML, it is intuitively
likely that this powerful drug is also suitable for non-sAML. The mechanism of action is
relevant for every AML. Following the FDA approval of the drug for sAML we would like to
evaluate its efficacy for low or intermediate risk fms-like tyrosine kinase 3 (FLT3)-negative
de novo AML patients. This consideration is particularly relevant by the inclusion of young
AML patients in the study.
Gemtuzumab ozogamicin (GO) Gemtuzumab ozogamicin (Mylotarg) - an anti-cluster of
differentiation 33 (CD33) monoclonal antibody linked to calicheamicin, was approved for the
treatment of newly diagnosed AML patients, when given as a combination with the '7+3'
regimen.
One of the goals of the current study is to examine the feasibility and efficacy of the
combination of Mylotarg plus Vyxeos.
Minimal/ measurable residual disease (MRD) Minimal or measurable residual disease (MRD)
denotes the presence of leukemia cells down to levels of 1:10-4 to 1:10-6, compared with 1:20
in morphology-based assessments. MRD can be evaluated using a variety of multiparameter flow
cytometry (MFC) and molecular methods. There are no data regarding the achievement or impact
of MRD using Vyxeos as induction therapy. The current trial will address this issue.
Purpose of this Trial The current study is designed to examine the response rate of the
Vyxeos as induction therapy for newly diagnosed low/intermediate risk AML patients in the
'real world' setting. Patients will receive the same induction therapy that they were to
receive had they not entered this study (cytarabine /daunorubicin ± Mylotarg) but the
combination of cytarabine /daunorubicin will be given in the unique formulation of Vyxeos. In
addition to classic CR+CRi evaluation, MFC MRD evaluation, using an centralized,
internationally recognized laboratory, will be done at the end of induction. In addition,
this pilot study will also provide clinical safety information about the combination of
Vyxeos with Mylotarg.