A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia
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Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
171actual
Sites
111
Countries
Canada, Puerto Rico, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2016-09-30 | actual | When the study began enrolling |
| Primary completion | 2026-03-03 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-03-03 | actual | The whole study's end, after follow-up |
| First posted | 2016-03-31 | estimated | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Leukemia
Interventions
- Drug: Ruxolitinib — also filed as INCB018424
- Drug: Asparaginase Erwinia Chrysanthemi
- Drug: Cyclophosphamide
- Drug: Cytarabine
- Drug: Dexamethasone
- Drug: Doxorubicin
- Drug: Leucovorin Calcium
- Drug: Mercaptopurine
- Drug: Methotrexate
- Drug: Pegaspargase
- Drug: Prednisone
- Drug: Thioguanine
- Drug: Vincristine Sulfate
Primary outcomes
what the primary-completion date above is the date OFPart 1: Safety/tolerability of ruxolitinib in combination with chemotherapy as measured by adverse events (AEs), vital signs, clinical laboratory tests, and echocardiograms
measured Part 1: AEs assessed from screening through up to 30 days after the last dose of study drug, expected to be 26 months (females) or 38 months (males)
Part 2: Efficacy of ruxolitinib in combination with chemotherapy as measured by Event-free survival, defined as the percentage of patients alive without relapse, progression, or death at 3 years from study Day 1
measured Part 2: assessed at 3 years
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