TITRE |
LCH-IV, Protocole de traitement collaboratif international pour enfants et adolescents atteints d’histiocytose à cellules de Langerhans |
PROTOCOLE ID |
LCH-IV |
CLINICAL TRIAL.gov ID |
NCT02205762 |
TYPE(S) DE CANCER |
Pédiatrique divers |
PHASE |
Phase II |
TYPE D'ÉTUDE |
Traitement |
INSTITUTION |
CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE
3175 Chemin de la Côte Sainte-Catherine
(514) 345-4931
|
VILLE |
Montréal
|
INVESTIGATEUR(RICE) PRINCIPAL(E) |
Jean-Marie Leclerc
|
COORDONATEUR(RICE) |
Maud Frizot maud.frizot@recherche-ste-justine.qc.ca 514-345-4931 poste 5467
|
STATUT |
Actif en recrutement
|
CRITÈRES D'ÉLIGIBILITÉ |
(EN)
|
CRITÈRES D'EXCLUSION |
(EN)
-
Stratum I
- Pregnancy (patients of child-bearing age must be appropriately tested before chemotherapy)
- LCH-related permanent consequences (e.g. vertebra plana, sclerosing cholangitis, lung fibrosis, etc.) in the absence of active disease
- Prior systemic therapy
-
Stratum II
- Patients with progressive disease in risk organs
- Permanent consequences (e.g. sclerosing cholangitis, lung fibrosis, etc.) without evidence of active LCH in the same organ or in any other locations
- No written consent of the patient or his/her parents or legal guardian
-
Stratum III
- The presence of any of the following criteria will exclude the patient from the study:
- Isolated sclerosing cholangitis without evidence of active hepatic LCH as the only evidence of risk organ involvement.
- Inadequate renal function as defined by serum creatinine > 3x normal for age
-
Stratum IV
- Pulmonary failure (requiring mechanical ventilation) not due to active LCH.
- Isolated liver sclerosis or pulmonary fibrosis, without active LCH.
- Uncontrolled active life-threatening infection.
- Decreased renal function with a GFR of less than 50ml/1.73m2/min.
- Pregnancy or active breast feeding
- Failure to provide signed informed consent
-
Stratum VI
- Patients with SS-LCH who have an isolated tumorous CNS lesion (they are eligible for Stratum V),
- Patients with isolated "CNS-risk" or multifocal bone lesions (they are eligible for Stratum I, Group 2)
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