| Titre |
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 |
| ClinicalTrials.gov ID |
NCT04849910 |
| Type(s) de cancer |
Leucémie myéloïde aiguë (LMA) |
| Phase |
Phase I-II |
| Type étude |
Clinique |
| Médicament |
VOR33 |
| Institution |
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
 PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX
5415 boul. de l'Assomption, Montréal, QC, H1T2M4
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dre Nadia Bambace
|
| Coordonnateur(trice) |
Olivier Cormier
514-252-3400 poste 5966
|
| Statut |
 Actif en recrutement |
| Date d'activation |
13-06-2022 |
| Critètes d'éligibilité |
- 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).
|
| Critètes d'exclusion |
- 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.
|
Groupe d'étude en oncologie du Québec