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

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

Status

Closed

Cancer Type

Leukemia

Trial Phase

Phase II

Eligibility

1 - 21 Years, Male and Female

Study Type

Treatment

NCT ID

NCT02723994

Protocol IDs

INCB 18424-269 (primary)
NCI-2016-01687
AALL1521

Study Sponsor

Incyte Corporation

NCI Full Details

http://clinicaltrials.gov/show/NCT02723994

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.

Eligibility

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

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston

1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

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