A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia
NCT ID: NCT02723994
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
171 participants
INTERVENTIONAL
2016-09-30
2026-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ruxolitinib in combination with chemotherapy
Ruxolitinib
In Part 1, ruxolitinib will be administered at a protocol-defined starting dose in combination with chemotherapy, with dose escalation and de-escalation following the rolling 6 study design. The established recommended starting dose will be taken forward into Part 2.
Asparaginase Erwinia Chrysanthemi
Cyclophosphamide
Cytarabine
Dexamethasone
Doxorubicin
Leucovorin Calcium
Mercaptopurine
Methotrexate
Pegaspargase
Prednisone
Thioguanine
Vincristine Sulfate
Interventions
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Ruxolitinib
In Part 1, ruxolitinib will be administered at a protocol-defined starting dose in combination with chemotherapy, with dose escalation and de-escalation following the rolling 6 study design. The established recommended starting dose will be taken forward into Part 2.
Asparaginase Erwinia Chrysanthemi
Cyclophosphamide
Cytarabine
Dexamethasone
Doxorubicin
Leucovorin Calcium
Mercaptopurine
Methotrexate
Pegaspargase
Prednisone
Thioguanine
Vincristine Sulfate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
* 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:
1. CRLF2 rearrangement with confirmed JAK1 or JAK2 mutation (JAK+)
2. CRLF2 rearrangement without JAK mutation
3. 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
* 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
1 Year
21 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Albert Assad, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Sarah Tasian, MD
Role: STUDY_CHAIR
Children's Hospital of Philadelphia, Philadelphia, PA
Locations
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The Childrens Hospital of Alabama
Birmingham, Alabama, United States
Phoenix Children'S Hospital
Phoenix, Arizona, United States
Arkansas Childrens Hospital
Little Rock, Arkansas, United States
Kaiser Permanente
Fontana, California, United States
Loma Linda University Cancer Center
Loma Linda, California, United States
Miller Childrens Hospital Pharmacy
Long Beach, California, United States
Children'S Hospital Los Angeles
Los Angeles, California, United States
Kaiser Foundation Health Plan
Los Angeles, California, United States
Southern California Permanente Medical Group
Los Angeles, California, United States
Valley Childrens Hospital
Madera, California, United States
Choc Children Hospital
Orange, California, United States
Lucille Packard Childrens Hospital
Palo Alto, California, United States
Kaiser Permanente
San Diego, California, United States
Rady Children'S Hospital - San Diego
San Diego, California, United States
Ucsf Pediatric Oncology
San Francisco, California, United States
Kaiser Permanente Downey
Santa Fe Springs, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
Connecticut Children'S Medical Ctr
Hartford, Connecticut, United States
Smilow Cancer Center - Yale
New Haven, Connecticut, United States
Alfred I. Dupont Hospital For Children
Wilmington, Delaware, United States
Childrens Hospital of Southwest Florida
Fort Myers, Florida, United States
Joe Dimaggio Children Hospital
Hollywood, Florida, United States
Nemours Childrens Clinic
Jacksonville, Florida, United States
University of Florida Health Shands Hospital
Jacksonville, Florida, United States
Florida Hospital Orlando
Orlando, Florida, United States
Arnold Palmer Hospital For Children
Orlando, Florida, United States
Nemours Childrens Clinic
Pensacola, Florida, United States
All Childrens Hospital
St. Petersburg, Florida, United States
St Josephs Childrens Hospital Tampa
Tampa, Florida, United States
Saint Marys Medical Center
West Palm Beach, Florida, United States
Egleston Children'S Health
Atlanta, Georgia, United States
Kapiolani Medical Center For Women and Children
Honolulu, Hawaii, United States
Ann & Robert H. Lurie Children'S Hospital
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Riley Hospital For Children
Indianapolis, Indiana, United States
St Vincent Hospital
Indianapolis, Indiana, United States
Blank Childrens Hospital
Des Moines, Iowa, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Kosair Childrens Hospital
Louisville, Kentucky, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Maine Center For Cancer Medicine
Scarborough, Maine, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Dana Farber Boston Children'S
Boston, Massachusetts, United States
Cs Mott Childrens Hospital
Ann Arbor, Michigan, United States
Helen Devos Childrens Hosp
Grand Rapids, Michigan, United States
Michigan State University
Lansing, Michigan, United States
Children'S Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
The Children'S Mercy Hospital Outpatient
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
Children'S Hospital & Medical Center
Omaha, Nebraska, United States
Alliance For Childhood Diseases
Las Vegas, Nevada, United States
Children'S Center For Cancer & Blood Dis
Las Vegas, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
Rutgers Cancer Institute of Nj
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
St Josephs Regional Medical Center
Paterson, New Jersey, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
Albany Medical College
Albany, New York, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Cohen Children'S Medical Center
New Hyde Park, New York, United States
Weill Cornell Medical College
New York, New York, United States
Nyu Clinical Cancer Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Suny Upstate Medical University
Syracuse, New York, United States
New York Medical College
Valhalla, New York, United States
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Akron Children'S Hospital
Akron, Ohio, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies & Children Hosp
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Nationwide Children'S Hospital
Columbus, Ohio, United States
Dayton Children'S Hospital
Dayton, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States
Doernbecher Childrens Hospital
Portland, Oregon, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Hasbro Childrens Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Dell Childrens Medical Center of Central Texas
Austin, Texas, United States
Driscoll Children'S Hospital
Corpus Christi, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
El Paso Children'S Hospital Corporation
El Paso, Texas, United States
Texas Childrens Hospital
Houston, Texas, United States
University of Texas Health Science Cente
San Antonio, Texas, United States
Primary Children'S Hospital
Salt Lake City, Utah, United States
Children'S Hospital of the
Norfolk, Virginia, United States
Seattle Children'S Hospital
Seattle, Washington, United States
Providence Sacred Heart Medical Center & Children'S Hospital
Spokane, Washington, United States
St Vincent Hospital
Green Bay, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Alberta'S Children Hospital
Calgary, Alberta, Canada
Bc Children'S Hospital
Vancouver, British Columbia, Canada
The Hospital For Sick Children
Toronto, Ontario, Canada
Chu Sainte-Justine
Montreal, Quebec, Canada
McGill University Health Centre/Glen Site/Cedars Cancer Centre
Montreal, Quebec, Canada
McMaster University Medical Centre
Hamilton, , Canada
University Pediatric Hospital
San Juan, PR, Puerto Rico
San Jorge Childrens Hospital
San Juan, , Puerto Rico
Countries
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Other Identifiers
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AALL1521
Identifier Type: OTHER
Identifier Source: secondary_id
INCB 18424-269
Identifier Type: -
Identifier Source: org_study_id
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