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LeukemiaPhase 2NCT02723994

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

A Phase 2 study testing Ruxolitinib, Asparaginase Erwinia Chrysanthemi and Cyclophosphamide in people with Leukemia, run by Incyte Corporation at 111 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 1 year to 21 years
Conditions the study is for
Leukemia
What is being tested?
Ruxolitinib, Asparaginase Erwinia Chrysanthemi and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
171 participants
Where
111 sitesin 3 countries
Study dates
30 Sep 2016to 3 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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:
  • Age ≥ 10 years
  • White blood cell (WBC) ≥ 50 × 10^3/μL
  • CNS3 leukemia at diagnosis
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  • 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:
  • CRLF2 rearrangement with confirmed JAK1 or JAK2 mutation (JAK+)
  • CRLF2 rearrangement without JAK mutation
  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

111 sites in 3 countries.

111 sites in 3 countries

United States103 sites

  • Akron Children'S Hospital

    Akron, Ohio, 44308

  • Albany Medical College

    Albany, New York, 12208

  • University of New Mexico Hospital

    Albuquerque, New Mexico, 87131

  • Cs Mott Childrens Hospital

    Ann Arbor, Michigan, 48109

  • Egleston Children'S Health

    Atlanta, Georgia, 30322-1060

  • Children'S Hospital Colorado

    Aurora, Colorado, 80045

  • Dell Childrens Medical Center of Central Texas

    Austin, Texas, 78723

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Johns Hopkins University

    Baltimore, Maryland, 21287-7049

  • The Childrens Hospital of Alabama

    Birmingham, Alabama, 35233

  • Dana Farber Boston Children'S

    Boston, Massachusetts, 02215

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

  • University of North Carolina At Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Ann & Robert H. Lurie Children'S Hospital

    Chicago, Illinois, 60611

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Rainbow Babies & Children Hosp

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Nationwide Children'S Hospital

    Columbus, Ohio, 43205

  • Driscoll Children'S Hospital

    Corpus Christi, Texas, 78411

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Dayton Children'S Hospital

    Dayton, Ohio, 45404

  • Blank Childrens Hospital

    Des Moines, Iowa, 50309

  • El Paso Children'S Hospital Corporation

    El Paso, Texas, 79905

  • Kaiser Permanente

    Fontana, California, 92335

  • Childrens Hospital of Southwest Florida

    Fort Myers, Florida, 33908

  • Helen Devos Childrens Hosp

    Grand Rapids, Michigan, 49503

  • St Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Connecticut Children'S Medical Ctr

    Hartford, Connecticut, 06106

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033-2360

  • Joe Dimaggio Children Hospital

    Hollywood, Florida, 33021

  • Kapiolani Medical Center For Women and Children

    Honolulu, Hawaii, 96826

  • Texas Childrens Hospital

    Houston, Texas, 77030

  • Riley Hospital For Children

    Indianapolis, Indiana, 46202

  • St Vincent Hospital

    Indianapolis, Indiana, 46260

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Nemours Childrens Clinic

    Jacksonville, Florida, 32207

  • University of Florida Health Shands Hospital

    Jacksonville, Florida, 32209

  • The Children'S Mercy Hospital Outpatient

    Kansas City, Missouri, 64108

  • Michigan State University

    Lansing, Michigan, 48912

  • Alliance For Childhood Diseases

    Las Vegas, Nevada, 89109

  • Children'S Center For Cancer & Blood Dis

    Las Vegas, Nevada, 89109

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Arkansas Childrens Hospital

    Little Rock, Arkansas, 72202

  • Loma Linda University Cancer Center

    Loma Linda, California, 92350

  • Miller Childrens Hospital Pharmacy

    Long Beach, California, 90806

  • Children'S Hospital Los Angeles

    Los Angeles, California, 90027

  • Kaiser Foundation Health Plan

    Los Angeles, California, 90027

  • Southern California Permanente Medical Group

    Los Angeles, California, 90027

  • Kosair Childrens Hospital

    Louisville, Kentucky, 40202

  • Valley Childrens Hospital

    Madera, California, 93636-8762

  • Loyola University Medical Center

    Maywood, Illinois, 60153-3328

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Children'S Hospitals and Clinics of Minnesota

    Minneapolis, Minnesota, 55404

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Morristown Medical Center

    Morristown, New Jersey, 07962

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Rutgers Cancer Institute of Nj

    New Brunswick, New Jersey, 08901

  • Smilow Cancer Center - Yale

    New Haven, Connecticut, 06510

  • Cohen Children'S Medical Center

    New Hyde Park, New York, 11040

  • Ochsner Clinic

    New Orleans, Louisiana, 70121

  • Weill Cornell Medical College

    New York, New York, 10021

  • Nyu Clinical Cancer Center

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Children'S Hospital of the

    Norfolk, Virginia, 23507

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Children'S Hospital & Medical Center

    Omaha, Nebraska, 68114

  • Choc Children Hospital

    Orange, California, 92868

  • Florida Hospital Orlando

    Orlando, Florida, 32803

  • Arnold Palmer Hospital For Children

    Orlando, Florida, 32806

  • Lucille Packard Childrens Hospital

    Palo Alto, California, 94304

  • St Josephs Regional Medical Center

    Paterson, New Jersey, 07503

  • Nemours Childrens Clinic

    Pensacola, Florida, 32504

  • Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Phoenix Children'S Hospital

    Phoenix, Arizona, 85016-7710

  • Childrens Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

  • Legacy Emanuel Hospital and Health Center

    Portland, Oregon, 97227

  • Doernbecher Childrens Hospital

    Portland, Oregon, 97239

  • Hasbro Childrens Hospital

    Providence, Rhode Island, 02903

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Primary Children'S Hospital

    Salt Lake City, Utah, 84113

  • University of Texas Health Science Cente

    San Antonio, Texas, 78229

  • Kaiser Permanente

    San Diego, California, 92111

  • Rady Children'S Hospital - San Diego

    San Diego, California, 92123

  • Ucsf Pediatric Oncology

    San Francisco, California, 94158

  • Kaiser Permanente Downey

    Santa Fe Springs, California, 90670

  • Maine Center For Cancer Medicine

    Scarborough, Maine, 04074

  • Seattle Children'S Hospital

    Seattle, Washington, 98105

  • Providence Sacred Heart Medical Center & Children'S Hospital

    Spokane, Washington, 99204

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Washington University

    St Louis, Missouri, 63130

  • All Childrens Hospital

    St. Petersburg, Florida, 33701

  • Suny Upstate Medical University

    Syracuse, New York, 13210

  • St Josephs Childrens Hospital Tampa

    Tampa, Florida, 33607

  • Toledo Hospital

    Toledo, Ohio, 43606

  • New York Medical College

    Valhalla, New York, 10595

  • Saint Marys Medical Center

    West Palm Beach, Florida, 33407

  • Alfred I. Dupont Hospital For Children

    Wilmington, Delaware, 19803

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada6 sites

  • Alberta'S Children Hospital

    Calgary, Alberta, T3B 6A8

  • McMaster University Medical Centre

    Hamilton, L8V 5C2

  • Chu Sainte-Justine

    Montreal, Quebec, H3T 1C5

  • McGill University Health Centre/Glen Site/Cedars Cancer Centre

    Montreal, Quebec, H4A 3J1

  • The Hospital For Sick Children

    Toronto, Ontario, 94611

  • Bc Children'S Hospital

    Vancouver, British Columbia, V6G1R8

Other trials in Canada

Puerto Rico2 sites

  • University Pediatric Hospital

    San Juan, PR, 00930

  • San Jorge Childrens Hospital

    San Juan, 00912

Other trials in Puerto Rico

About this study

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

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.

Conditions
Leukemia
Being tested
Ruxolitinib, Asparaginase Erwinia Chrysanthemi, Cyclophosphamide, Cytarabine, Dexamethasone
Keywords
B-cell acute lymphoblastic leukemia (ALL), pediatric, multi-agent chemotherapy, JAK inhibitor
Medical subject headings
Leukemia, Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02723994
Study groupRoleWhat they receive
Ruxolitinib in combination with chemotherapyExperimentalNot described
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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)

  2. 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

    Measured: Part 2: assessed at 3 years

Secondary outcomes (1)

  1. 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

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2016 (estimated)
  2. Study start30 Sep 2016
  3. Primary completion3 Mar 2026
  4. Study completion3 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02723994
Sponsor's protocol ID
INCB 18424-269
Other IDs
AALL1521
Status last verified
Mar 2026
First submitted
9 Mar 2016
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
Yes
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ruxolitinib, Asparaginase Erwinia Chrysanthemi and Cyclophosphamide in people with Leukemia, run by Incyte Corporation at 111 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Safety/tolerability of ruxolitinib in combination with chemotherapy as measured by adverse events (AEs), vital signs, clinical laboratory tests, and echocardiograms (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02723994.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

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