Home » Clinical Trials » AALL1521, A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK PathwayMutant Acute Lymphoblastic Leukemia
This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the recommended dose determined in Part 1.
Principal Investigator:
Van Huynh, MD
Research Coordinator:
Kathryn Duvall
(714) 509-8646
Visit clinicaltrials.gov for more information about this trial.
- IRB Number: 160659
- Sponsor: Incyte-COG
- Protocol Number: AALL1521
- NCT Number: NCT02723994
- Research Type: Adolescents and Young Adults, Leukemia
- Phase: II
- Status: Active
Inclusion:
- Ages 2 years to 21 years
- De novo high-risk (HR) Ph-like B-ALL
- 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 alteration
- Completed a 4-drug Induction therapy regimen (modified aBFM regimen or equivalent) in for HR B-ALL and have had end-Induction minimal residual disease (MRD) assessed Standard COG organ function
Exclusion:
- Receipt of any other cytotoxic chemotherapy before Induction therapy, with exception of hydroxyurea or steroid pretreatmen
- Trisomy 21 (Down syndrome)
- BCR-ABL1-rearranged (Ph+) ALL
