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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2024
  • participants needed
    170
  • sponsor
    Incyte Corporation
Updated on 22 July 2022
cyclophosphamide
methotrexate
cytarabine
prednisone
mercaptopurine
asparaginase
pegaspargase
dexamethasone
combination chemotherapy
thioguanine

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.

Description


Details
Condition Leukemia
Treatment cyclophosphamide, methotrexate, Leucovorin calcium, cytarabine, prednisone, vincristine sulfate, Ruxolitinib, Dexamethasone, doxorubicin, Pegaspargase, Asparaginase Erwinia Chrysanthemi, Mercaptopurine, Thioguanine
Clinical Study IdentifierNCT02723994
SponsorIncyte Corporation
Last Modified on22 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Eligible for study when participant is 1 year to 21 years at the time of diagnosis
Eligible Ages in Australia and 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

Exclusion Criteria

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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