About this trial
This study will test if adding ruxolitinib to standard multi-drug chemotherapy regimen will be safe and tolerated in adolescents and young adults with newly diagnosed Ph-like acute lymphoblastic leukemia (ALL).
Eligibility criteria
Qualifiers
Newly diagnosed de novo B-precursor acute lymphoblastic leukemia (ALL) as determined by World Health Organization (WHO) criteria. Patients must have unequivocal diagnosis of precursor B ALL. This includes an institutional immunophenotyping report that is to assign B-lineage or T-lineage.
"Ph-like" signature, as determined by low density micro-array (LDA) card
Cytokine receptor-like factor 2 (CRLF2) rearranged (JAK2 mutant or wild-type)
JAK2 or erythropoietin receptor (EPOR) fusions.
Disqualifiers
Patients who are receiving any other investigational agent.
Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib or other agents used in study.
Use of any potent cytochrome P450 (CYP) 3A4 inhibitor or inducer within 5 half-lives before the first dose of the study drug. Potent inhibitors of CYP3A4 include systemic ketoconazole, posaconazole, voriconazole, clarithromycin, itraconazole, nefazodone, and telithromycin. At the fluconazole dose of 200mg daily used this regimen, there is minimal inhibition of CYP3A4 [36] and therefore fluconazole is not prohibited on this trial and no dose modifications should be made in the presence of fluconazole.
Trial design
Treatments tested in this trial
- Ruxolitinib
- Cyclophosphamide
- Cytarabine
- Mercaptopurine
- Vincristine
- Pegaspargase
- Rituximab
- Methotrexate (Intrathecal Administration)
- Methotrexate (Intravenous Administration)
- Dexamethasone
- Doxorubicin
- Thioguanine
- Methotrexate Oral Product
Treatment groups
Sponsors and collaborators
University of Chicago
Lead sponsor
Incyte Corporation
Collaborator