| Titre |
Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia |
| Protocole ID |
CFZ008 |
| ClinicalTrials.gov ID |
NCT02303821 |
| Type(s) de cancer |
Pédiatrique divers |
| Phase |
Phase I-II |
| Type étude |
Traitement |
| Médicament |
carfilzomib |
| Institution |
CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Henrique Bittencourt
|
| Coordonnateur(trice) |
Lynda Dufresne
514-345-4931 poste 4969
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
-
Age 21 years or younger at the time of initial ALL diagnosis and age > 1 year at the time of study treatment initiation.
-
Subjects must have a diagnosis of relapsed or refractory ALL with ≥ 5% blasts in the bone marrow (M2 or M3 disease), with or without extramedullary disease.
-To be eligible, subjects must have had 1 or more prior therapeutic attempts, defined as:
-
Early first relapse (< 36 months from original diagnosis) after achieving a CR (B-ALL) or first relapse any time following the original diagnosis after achieving a CR (T-ALL)
-
Relapse after achieving a CR following the first or subsequent relapse (i.e., ≥ 2 relapses) OR
-
Failing to achieve a CR from original diagnosis after at least 1 induction attempt
-
Subjects must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy treatment before enrollment.
-
Subjects must have a serum creatinine level that is ≤ 1.5 × institutional upper limit of normal (ULN) according to age. If serum creatinine level is > 1.5 × ULN, the subject must have a calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m2.
-
Adequate liver function, defined as both of the following:
-
Total bilirubin ≤ 1.5 × institutional ULN except in the presence of Gilbert Syndrome
-
Alanine aminotransferase (ALT) ≤ 5 × institutional ULN
-
Performance status: Karnofsky or Lansky scores ≥ 50 for subjects > 16 years old or ≤ 16 years old, respectively.
|
| Critètes d'exclusion |
-
Known allergy to any of the drugs used in the study. (Subjects who have had a previous allergy to PEG-asparaginase but can receive Erwinia are eligible.)
-
Known allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
-
Left ventricular fractional shortening < 30%
-
History of ≥ Grade 2 pancreatitis
-
Active graft?versus?host disease requiring systemic treatment
-
Positive culture for or other clinical evidence of infection with bacteria or fungus within 14 days of the initiation of study treatment
-
Down Syndrome
-
Prior therapy restrictions:
-
Subjects must have completed therapy with granulocyte?colony stimulating factor (G?CSF) or other myeloid growth factors at least 7 days before study treatment initiation, or at least 14 days before study treatment initiation, if pegylated myeloid growth factors were administered.
-
Subjects must have completed any type of active immunotherapy (e.g., tumor vaccines) at least 42 days before study treatment initiation.
-
At least 3 antibody half?lives must have elapsed since the last dose of monoclonal antibody (e.g., 66 days for rituximab and 69 days for epratuzumab) before subjects may initiate study treatment.
-
Subjects must have completed any type of active immunotherapy (e.g., tumor vaccines) at least 42 days before study treatment initiation.
-
Subjects must not have received other antineoplastic agents with therapeutic intent, excluding hydroxyurea and antimetabolites administered as part of maintenance chemotherapy, within 7 days prior to study treatment initiation
|
Groupe d'étude en oncologie du Québec