A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia
Trial Status: Active
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.
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
Alabama
Birmingham
Children's Hospital of Alabama
Status: ACTIVE
Contact: Matthew A. Kutny
Phone: 205-638-9285
Email:
mkutny@peds.uab.edu
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Matthew A. Kutny
Phone: 205-638-9285
Email:
mkutny@peds.uab.edu
California
Los Angeles
Children's Hospital Los Angeles
Status: ACTIVE
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: ACTIVE
Stanford Cancer Institute Palo Alto
Status: ACTIVE
San Diego
Rady Children's Hospital - San Diego
Status: ACTIVE
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
Connecticut
New Haven
Yale University
Status: ACTIVE
Georgia
Atlanta
Children's Healthcare of Atlanta - Egleston
Status: ACTIVE
Contact: Melinda Gordon Pauly
Phone: 888-785-1112
Email:
melinda.pauly@choa.org
Hawaii
Honolulu
Kapiolani Medical Center for Women and Children
Status: ACTIVE
Illinois
Chicago
Lurie Children's Hospital-Chicago
Status: ACTIVE
Indiana
Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Fernanda Rankin
Phone: 317-944-8784
Email:
fecarnev@iu.edu
Iowa
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE
Kansas
Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: KUCC CTO Clinical Systems Administrator
Phone: 913-588-6291
Email:
rmay2@kumc.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
Dana-Farber Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Minnesota
Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ACTIVE
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE
Nebraska
Omaha
Children's Hospital and Medical Center of Omaha
Status: ACTIVE
New Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE
New Mexico
Albuquerque
University of New Mexico Cancer Center
Status: ACTIVE
New York
Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE
North Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE
Contact: Seth J. Rotz
Phone: 216-217-8106
Email:
rotzs@ccf.org
Columbus
Nationwide Children's Hospital
Status: ACTIVE
Oklahoma
Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Oregon
Portland
OHSU Knight Cancer Institute
Status: ACTIVE
Pennsylvania
Philadelphia
Children's Hospital of Philadelphia
Status: ACTIVE
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: ACTIVE
South Carolina
Charleston
Medical University of South Carolina
Status: ACTIVE
Tennessee
Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE
Texas
Houston
Texas Children's Hospital
Status: ACTIVE
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
Virginia
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: WITHDRAWN
Washington
Seattle
Seattle Children's Hospital
Status: ACTIVE
Trial Phase Phase II
Trial Type Treatment
Lead Organization
Incyte Corporation
- Primary ID INCB 18424-269
- Secondary IDs NCI-2016-01687, AALL1521
- Clinicaltrials.gov ID NCT02723994