| TITRE |
Étude de phase II visant à évaluer le ruxolitinib, un inhibiteur de JAK1/JAK2, en association avec la chimiothérapie chez des enfants atteints de leucémie aiguë lymphoblastique de novo à risque élevé présentant un réarrangement de CRLF2 et/ou une mutation dans la voie JAK
|
| PROTOCOLE ID |
COG-AALL1521 |
| CLINICAL TRIAL.gov ID |
NCT02723994 |
| TYPE(S) DE CANCER |
Pédiatrique divers |
| PHASE |
Phase II |
| TYPE D'ÉTUDE |
|
| INSTITUTION |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Sharon Abish
|
| COORDONATEUR(RICE) |
Stephanie Badour
stephanie.badour@muhc.mcgill.ca
514-412-4400 poste 23807
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
-
De novo high-risk (HR) Ph-like B-ALL for which any of following criteria are present at diagnosis:
- Age ≥ 10 years
- White blood cell (WBC) ≥ 50 × 10^3/μL
- CNS3 leukemia
-
One of the following Ph-like ALL genetic lesions must be present in the diagnostic bone marrow or peripheral blood sample:
- CRLF2 rearrangement with JAK1 or JAK2 mutation (JAK+)
- CRLF2 rearrangement without JAK mutation
- Other JAK pathway alterations (eg, JAK2 fusions, erythropoietin receptor (EPO-R) fusions, SH2B3 deletions, interleukin-7 receptor-alpha (IL7RA) mutations) with or without CRLF2 rearrangement
- Completed a 4-drug Induction therapy regimen (modified aBFM regimen or equivalent) in Study AALL1131 or as the institutional standard of care for HR B-ALL and have had end-Induction minimal residual disease (MRD) assessed
- Male and female subjects of reproductive non childbearing potential or willing to take appropriate precautions to avoid pregnancy or fathering a child for the duration of study participation
|
| CRITÈRES D'EXCLUSION |
(EN)
- Receipt of any other cytotoxic chemotherapy before Induction therapy, with exception of hydroxyurea or steroid pretreatment
- Trisomy 21 (Down syndrome)
- BCR-ABL1-rearranged (Ph+) ALL
- Calculated creatinine clearance or radioisotope glomerular filtration rate < 70 mL/min/1.73 m^2
- Alanine aminotransferase ≥ 3 × upper limit of normal (ULN) for age
- Direct bilirubin ≥ 1.5 × ULN (may be assumed if total bilirubin is below ULN)
- History or evidence of cirrhosis
- Platelet count < 75 × 10^3/μL
- Absolute neutrophil count (ANC) < 750/μL
- Positive screen for hepatitis B or C
- Known human immunodeficiency virus infection
|
