Leukemia
A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia
Incyte Study ID:
INCB 18424-269
CT.gov ID:
Eudra ID:
N/A
EU CT Number:
N/A
Sponsor:
Incyte Corporation
Collaborator:
Children's Oncology Group
Study Contact Information:
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)
PRODUCT
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 UsName
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
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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)
Requirements information
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
- • De novo high-risk (HR) Ph-like B-ALL for which any of following criteria are present at diagnosis:
- o Age ≥ 10 years
- o White blood cell (WBC) ≥ 50 × 10^3/μL
- o CNS3 leukemia at diagnosis
- o 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:
- a. CRLF2 rearrangement with confirmed JAK1 or JAK2 mutation (JAK+)
- b. CRLF2 rearrangement without JAK mutation
- c. 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
Protocol Summary
Incyte Study ID:
INCB 18424-269
Primary Purpose:
Treatment
Allocation:
N/A
Study Design:
Single Group Assignment
Masking:
None (Open Label)
Interventions:
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)