Leucémie myéloïde aiguë (LMA)

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TITRE (EN) A First-In-Human, Open-Label, Multicenter Study of VOR33 in Patients With Acute Myeloid Leukemia Who Are at High-Risk for Leukemia Relapse Following Hematopoietic Cell Transplantation
PROTOCOLE ID VBP101
CLINICAL TRIAL.gov ID NCT04849910
TYPE(S) DE CANCER Leucémie myéloïde aiguë (LMA)
PHASE Phase I-II
TYPE D'ÉTUDE Clinique
INSTITUTION HOPITAL MAISONNEUVE-ROSEMONT
5415 boul. de l'Assomption
(514) 252-3400
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Nadia Bambace
COORDONATEUR(RICE) Olivier Cormier
olivier.cormier.cemtl@ssss.gouv.qc.ca
514-252-3400 poste 5966
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • Must be ≥18 and ≤70 years of age.
  • Must have confirmed diagnosis of AML in first or second complete remission (CR1 or CR2) or have bone marrow blasts ≤10% without circulating blasts.
  • AML sample from the patient must have evidence of CD33 expression (>0%)
  • AML must have intermediate or high-risk disease-related genetics and the presence of minimal residual disease (MRD). Subjects in CR2 or with persistent morphologic blasts; may have favorable disease-related genetics.
  • Candidate for HLA-matched allogeneic HCT using a myeloablative conditioning regimen.
  • Must have a related or unrelated stem cell donor that is a 10/10 match for HLA-A, -B, -C, -DRB1 and -DQB1.

  • Must have adequate performance status and organ function as defined below:

    • Performance Status: Karnofsky score of ≥70.
    • Cardiac: left ventricular ejection fraction (LVEF) ≥50%
    • Pulmonary: diffusing capacity of lung for carbon monoxide (DLCO), forced vital capacity (FVC), and forced expiratory volume in one second (FEV1) ≥66%.
    • Renal: estimated glomerular filtration rate (GFR) >60 mL/min
    • Hepatic: total bilirubin <1.5 × ULN, or if ≥1.5 × ULN direct bilirubin <ULN and ALT/AST <1.5 × ULN (per institutional criteria).
CRITÈRES D'EXCLUSION (EN)
  • Prior autologous or allogeneic stem cell transplantation.
  • Presence of the following disease-related genetics: t(15; 17)(q22; q21), or t(9; 22)(q34; q11), or other evidence of acute promyelocytic leukemia or chronic myeloid leukemia.
  • Prior treatment with Mylotarg™ (gemtuzumab ozogamicin).
  • Active central nervous system (CNS) leukemia or history of other active malignancy(ies).
  • Patients diagnosed with Gilbert's syndrome.
  • Uncontrolled bacterial, viral, or fungal infections; or known human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection.