For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Eligible for study when participant is 1 year to 21 years at the time of diagnosis
  2. Eligible Ages in Australia and Canada; 2 years to 21 years
  3. De novo high-risk (HR) Ph-like B-ALL for which any of following criteria are present at diagnosis:
  4. Age ≥ 10 years
  5. White blood cell (WBC) ≥ 50 × 10^3/μL
  6. CNS3 leukemia at diagnosis
  7. Systemic steroid pretreatment without presteroid WBC documentation
  8. 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:
  9. CRLF2 rearrangement* with confirmed JAK1 or JAK2 mutation (JAK+)
  10. CRLF2 rearrangement* without JAK mutation
  11. 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
  12. 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
  13. 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

EXCLUSION CRITERIA

  1. Receipt of any other cytotoxic chemotherapy before Induction therapy, with exception of hydroxyurea or steroid pretreatment
  2. Trisomy 21 (Down syndrome)
  3. BCR-ABL1-rearranged (Ph+) ALL
  4. Calculated creatinine clearance or radioisotope glomerular filtration rate < 70 mL/min/1.73 m^2
  5. Alanine aminotransferase ≥ 5 × upper limit of normal (ULN) for age
  6. Direct bilirubin ≥ 1.5 × ULN (may be assumed if total bilirubin is below ULN)
  7. History or evidence of cirrhosis
  8. Platelet count < 75 × 10^3/μL
  9. Absolute neutrophil count (ANC) < 750/μL
  10. Positive screen for hepatitis B or C
  11. Known human immunodeficiency virus infection
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1.855.463.3463

Study’s details


Contition

ALL (Acute Lymphoblastic Leukemia),B-cell Acute Lymphoblastic Leukemia,Leukemia

Age

1+

Phase

Phase 2

Participants needed

170

Est. Completion Date

Sep 2025

Treatment type

Interventional


Sponsor

Incyte Corporation

ClinicalTrials.gov identifier

NCT02723994

Study number

INCB 18424-269

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