| Titre |
A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway-Mutant Acute Lymphoblastic Leukemia |
| Protocole ID |
COG-AALL1521 |
| ClinicalTrials.gov ID |
NCT02723994 |
| Type(s) de cancer |
Pédiatrique divers |
| Phase |
Phase II |
| Institution |
CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Yvan Samson
|
| Coordonnateur(trice) |
Clemence Noury
514-345-4931 poste 6848
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
-
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
|
| Critètes d'exclusion |
- 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
|
Groupe d'étude en oncologie du Québec