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

Status: Active

Description

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 Criteria

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

Locations & Contacts

California

Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: Active
Name Not Available
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
San Diego
Rady Children's Hospital - San Diego
Status: Active
Name Not Available
San Francisco
UCSF Medical Center-Mount Zion
Status: Active
Contact: Elizabeth Pon
Phone: 415-476-0660
Email: elizabeth.pon@ucsf.edu

Colorado

Aurora
Children's Hospital Colorado
Status: Active
Name Not Available

Connecticut

New Haven
Yale University
Status: Active
Name Not Available

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: Active
Contact: Melinda Gordon Pauly
Phone: 888-785-1112
Email: melinda.pauly@choa.org

Illinois

Chicago
Lurie Children's Hospital-Chicago
Status: Active
Name Not Available

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Active
Contact: Melissa Lee
Phone: 317-944-4281
Email: mellee@iu.edu

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: Active
Contact: Lars Martin Wagner
Phone: 859-257-3379
Email: lars.wagner@uky.edu

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Patrick A. Brown
Phone: 410-955-8804
Email: jhcccro@jhmi.edu

Massachusetts

Boston
Boston Children's Hospital
Status: Temporarily closed to accrual
Name Not Available
Dana-Farber Cancer Institute
Status: Temporarily closed to accrual
Name Not Available

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Name Not Available

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

Nebraska

Omaha
Children's Hospital and Medical Center of Omaha
Status: Active
Name Not Available

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Name Not Available

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Name Not Available

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Aron Flagg
Phone: 866-223-8100
Email: flagga@ccf.org
Columbus
Nationwide Children's Hospital
Status: Active
Name Not Available

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Pennsylvania

Philadelphia
Children's Hospital of Philadelphia
Status: Active
Name Not Available
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: Active
Name Not Available

South Carolina

Charleston
Medical University of South Carolina
Status: Active
Name Not Available

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Name Not Available

Texas

Houston
Texas Children's Hospital
Status: Active
Name Not Available
San Antonio
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Status: Active
Contact: Anne-Marie R. Langevin
Phone: 210-450-3800
Email: CTO@uthscsa.edu

Utah

Salt Lake City
Primary Children's Hospital
Status: Active
Name Not Available

Washington

Seattle
Seattle Children's Hospital
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Incyte Corporation

Trial IDs

Primary ID INCB 18424-269
Secondary IDs NCI-2016-01687, AALL1521
Clinicaltrials.gov ID NCT02723994