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

a study on Leukemia Acute Lymphoblastic Leukemia

Summary

for people ages 1-21 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Mignon Loh

Description

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.

Official Title

A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway-Mutant Acute Lymphoblastic Leukemia

Keywords

Leukemia B-cell acute lymphoblastic leukemia (ALL) pediatric multi-agent chemotherapy JAK inhibitor Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Dexamethasone Prednisone Pegaspargase Cyclophosphamide Doxorubicin Methotrexate Cytarabine Vincristine Asparaginase 6-Mercaptopurine Thioguanine Levoleucovorin Ruxolitinib Asparaginase Erwinia Chrysanthemi Leucovorin Calcium Mercaptopurine Vincristine Sulfate

Eligibility

You can join if…

Open to people ages 1-21

  • 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 × 103/μL

  • CNS3 leukemia
  • Systemic steroid pretreatment without presteroid WBC documentation
  • 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

You CAN'T join if...

  • 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 m2

  • 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 × 103/μL

  • Absolute neutrophil count (ANC) < 750/μL
  • Positive screen for hepatitis B or C
  • Known human immunodeficiency virus infection

Locations

  • UCSF Pediatric Hematolgy/Onclgy accepting new patients
    San Francisco California 94143 United States
  • Kaiser Permanente Medical Center - Northern California not yet accepting patients
    Oakland California 94611 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT02723994
Phase
Phase 2
Lead Scientist
Mignon Loh
Study Type
Interventional
Last Updated
March 22, 2018