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

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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

  • 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
  • One of the following Ph-like ALL genetic lesions must be present in the diagnostic bone marrow or peripheral blood sample:
  • CRLF2 rearrangement with JAK1 or JAK2 mutation (JAK+)
  • CRLF2 rearrangement without JAK mutation
  • Other JAK pathway alterations (eg, JAK2 fusions, erythropoietin receptor (EPO-R) fusions, SH2B3 deletions, interleukin-7 receptor-alpha (IL7RA) mutations) with or without CRLF2 rearrangement
  • Completed a 4-drug Induction therapy regimen (modified aBFM regimen or equivalent) in Study AALL1131 or as 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 ≥ 3 × 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

Georgia

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

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Active
Name Not Available

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

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available
New York
Columbia University / Herbert Irving 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: Active
Contact: Aron Flagg
Phone: 866-223-8100 Email: flagga@ccf.org

South Carolina

Charleston
Medical University of South Carolina
Status: In review
Name Not Available

Texas

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

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: In review
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