| TITRE |
Étude internationale de phase 3 sur la leucémie lymphoblastique aiguë à chromosome Philadelphie (LL Ph +) de Philadelphie testant l'imatinib en association avec deux épines dorsales de chimiothérapie cytotoxique
|
| PROTOCOLE ID |
COG-AALL1631 |
| CLINICAL TRIAL.gov ID |
NCT03007147 |
| TYPE(S) DE CANCER |
Pédiatrique divers |
| PHASE |
Phase III |
| TYPE D'ÉTUDE |
|
| INSTITUTION |
CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE
3175 Chemin de la Côte Sainte-Catherine
(514) 345-4931
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Henrique Bittencourt
|
| COORDONATEUR(RICE) |
Clemence Noury
clemence.noury@recherche-ste-justine.qc.ca
514-345-4931 poste 6848
|
| STATUT |
Actif en recrutement
|
| DATE D'ACTIVATION |
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Patients who have not previously enrolled on AALL08B1 or APEC14B1 (if open for classification of newly diagnosed ALL patients) prior to enrollment on AALL1631, a baseline diagnostic sample must be available to develop an MRD probe
-
Newly diagnosed de novo ALL (B-ALL or T-ALL) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR
- For patients who DO NOT enter AALL1631 via AALL08B1 or APEC14B1 (if open for classification of newly diagnosed ALL patients), laboratory reports detailing evidence of BCR-ABL1 fusion must be submitted for rapid central review within 72 hours of study enrollment
- Patients with known chronic myelogenous leukemia (CML) who develop lymphoid blast crisis are not eligible
- Patient must have previously started induction therapy, which includes vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or other standard cytotoxic chemotherapy
- Patient has not received more than 14 days of induction therapy
- Patient has not had prior treatment with imatinib, dasatinib, or any other BCR-ABL1 inhibitor
- Karnofsky/Lansky performance status >= 60; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
- Direct bilirubin =< 2.0 mg/dL
- Shortening fraction of >= 27% by echocardiogram
- Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram
-
Corrected QT interval, QTc < 480 msec
- Note: Repeat echocardiogram is not required if echocardiogram was obtained within 21 days of study enrollment
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2
-
Serum creatinine within normal limits based on age/gender, as follows:
- 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
- 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
- 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)
- 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
- 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
- >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)
|
| CRITÈRES D'EXCLUSION |
(EN)
|
