Leukemia

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

Incyte Study ID:
INCB 18424-269
CT.gov ID:
NCT02723994
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
Children's Oncology Group
Study Contact Information:
1.855.463.3463
Recruitment Complete
Subscribe to UpdatesContact Us

Clinical Study Purpose

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.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Leukemia
    • PRODUCT
  • Drug: Ruxolitinib
  • Drug: Asparaginase Erwinia Chrysanthemi
  • Drug: Cyclophosphamide
  • Drug: Cytarabine
  • Drug: Dexamethasone
  • Drug: Doxorubicin
  • Drug: Leucovorin Calcium
  • Drug: Mercaptopurine
  • Drug: Methotrexate
  • Drug: Pegaspargase
  • Drug: Prednisone
  • Drug: Thioguanine
  • Drug: Vincristine Sulfate
    • COLLABORATORS
    Children's Oncology Group
    DATE
    Sep 2016 - Feb 2026
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    1 - 21 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    THE CHILDRENS HOSPITAL OF ALABAMA
    BIRMINGHAM, AL, US, 35233
    Name
    PHOENIX CHILDREN'S HOSPITAL
    PHOENIX, AZ, US, 85016-7710
    Name
    ARKANSAS CHILDRENS HOSPITAL
    LITTLE ROCK, AR, US, 72202
    Name
    KAISER PERMANENTE
    FONTANA, CA, US, 92335
    Name
    LOMA LINDA UNIVERSITY CANCER CENTER
    LOMA LINDA, CA, US, 92350
    Name
    MILLER CHILDRENS HOSPITAL PHARMACY
    LONG BEACH, CA, US, 90806

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Eligible for study when participant is 1 year to 21 years at the time of diagnosis
    • Eligible Ages in Canada; 2 years to 21 years

    Exclusion Criteria

    • Receipt of any other cytotoxic chemotherapy before Induction therapy, with exception of hydroxyurea or steroid pretreatment
    • Trisomy 21 (Down syndrome)

    Protocol Summary

    Incyte Study ID:
    INCB 18424-269
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    171
    Primary Outcome
    Open

    Part 1: Safety/tolerability of ruxolitinib in combination with chemotherapy as measured by adverse events (AEs), vital signs, clinical laboratory tests, and echocardiograms

    Timeframe: Part 1: AEs assessed from screening through up to 30 days after the last dose of study drug, expected to be 26 months (females) or 38 months (males)

    Part 2: Efficacy of ruxolitinib in combination with chemotherapy as measured by Event-free survival, defined as the percentage of patients alive without relapse, progression, or death at 3 years from study Day 1

    Timeframe: Part 2: assessed at 3 years

    Secondary Outcome
    Open

    Safety and tolerability of the combination treatment for subjects beginning treatment at the recommended dose for Part 2, as assessed by AEs, vital signs, clinical laboratory tests, and echocardiograms

    Timeframe: AEs assessed from screening through up to 30 days after the last dose of study treatment, expected to be 26 months (females) or 38 months (males)