NCT02723994

A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	Ruxolitinib	In Part 1, ruxolitinib will be administered at a protocol-defined starting dose in combination with chemotherapy, with dose escalation and de-escalation following the rolling 6 study design. The established recommended starting dose will be taken forward into Part 2.
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

Timeline

• Start date: 2016-09-30
• Primary completion: 2026-03-03
• Completion: 2026-03-03
• First posted: 2016-03-31
• Last updated: 2026-03-11

Locations

111 sites across 3 countries: United States, Canada, Puerto Rico