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

Completed · Phase 2

Conditions studied: Leukemia

In brief

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.

Key facts

Study ID

NCT02723994

Run by

Incyte Corporation

People needed

171

Starts

2016-09-30

Expected to finish

2026-03-03

Last updated by the study team

2026-03-11

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligible for study when participant is 1 year to 21 years at the time of diagnosis
• Eligible Ages in Canada; 2 years to 21 years
• 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 at diagnosis
• Systemic steroid pretreatment without presteroid WBC documentation
• Diagnostic bone marrow or peripheral blood sample must have gene expression profiling and downstream genetic testing performed by submitting diagnostic specimens under the COG AALL08B1 or APEC14B1 biology studies, or AALL1131 or its successor study. Specimens must demonstrate a Ph-like expression profile (ie, LDA-positive) as tested by low density microarray testing at the COG ALL reference laboratory or TriCore laboratory at the University of New Mexico AND must contain 1 of the following genetic lesions: (determined at COG ALL reference laboratories, or equivalent CAP/CLIA-certified laboratories approved by the medical monitor:
• CRLF2 rearrangement with confirmed JAK1 or JAK2 mutation (JAK+)
• CRLF2 rearrangement without JAK mutation
• Other JAK pathway alterations (eg, JAK2 fusions, EPOR fusions, SH2B3 deletions, IL7RA mutations) with or without CRLF2-R, or CRLF2-R with unknown JAK status as determined by a COG ALL Reference Laboratory
• Completed a 4-drug Induction therapy regimen (modified aBFM regimen or equivalent) in Study AALL1131 or its successor study, or as per 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

You may not qualify if…

• 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 ≥ 5 × 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

Where it is running

• Phoenix Children'S Hospital — Phoenix, Arizona, United States
• Arkansas Childrens Hospital — Little Rock, Arkansas, United States
• Kaiser Permanente — Fontana, California, United States
• Loma Linda University Cancer Center — Loma Linda, California, United States
• Miller Childrens Hospital Pharmacy — Long Beach, California, United States
• Children'S Hospital Los Angeles — Los Angeles, California, United States
• Kaiser Foundation Health Plan — Los Angeles, California, United States
• Southern California Permanente Medical Group — Los Angeles, California, United States
• Valley Childrens Hospital — Madera, California, United States
• Choc Children Hospital — Orange, California, United States
• Lucille Packard Childrens Hospital — Palo Alto, California, United States
• Kaiser Permanente — San Diego, California, United States
• Rady Children'S Hospital - San Diego — San Diego, California, United States
• Ucsf Pediatric Oncology — San Francisco, California, United States
• Kaiser Permanente Downey — Santa Fe Springs, California, United States
• Children'S Hospital Colorado — Aurora, Colorado, United States
• Connecticut Children'S Medical Ctr — Hartford, Connecticut, United States
• Smilow Cancer Center - Yale — New Haven, Connecticut, United States
• Alfred I. Dupont Hospital For Children — Wilmington, Delaware, United States
• Childrens Hospital of Southwest Florida — Fort Myers, Florida, United States
• Joe Dimaggio Children Hospital — Hollywood, Florida, United States
• Nemours Childrens Clinic — Jacksonville, Florida, United States
• University of Florida Health Shands Hospital — Jacksonville, Florida, United States
• Florida Hospital Orlando — Orlando, Florida, United States
• The Childrens Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.