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

Primary Purpose

Leukemia

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ruxolitinib
Asparaginase Erwinia Chrysanthemi
Cyclophosphamide
Cytarabine
Dexamethasone
Doxorubicin
Leucovorin Calcium
Mercaptopurine
Methotrexate
Pegaspargase
Prednisone
Thioguanine
Vincristine Sulfate
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring B-cell acute lymphoblastic leukemia (ALL), pediatric, multi-agent chemotherapy, JAK inhibitor

Eligibility Criteria

1 Year - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eligible for study when participant is 1 year to 21 years at the time of diagnosis
  • 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 × 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:

  • 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

Sites / Locations

  • The Childrens Hospital of Alabama
  • Phoenix Children'S Hospital
  • Arkansas Childrens Hospital
  • Kaiser Permanente
  • Loma Linda University Cancer Center
  • Miller Childrens Hospital Pharmacy
  • Children'S Hospital Los Angeles
  • Kaiser Foundation Health Plan
  • Southern California Permanente Medical Group
  • Valley Childrens Hospital
  • Choc Children Hospital
  • Lucille Packard Childrens Hospital
  • Kaiser Permanente
  • Rady Children'S Hospital - San Diego
  • Ucsf Pediatric Oncology
  • Kaiser Permanente Downey
  • Children'S Hospital Colorado
  • Connecticut Children'S Medical Ctr
  • Smilow Cancer Center - Yale
  • Alfred I. Dupont Hospital For Children
  • Childrens Hospital of Southwest Florida
  • Joe Dimaggio Children Hospital
  • Nemours Childrens Clinic
  • University of Florida Health Shands Hospital
  • Florida Hospital Orlando
  • Arnold Palmer Hospital For Children
  • Nemours Childrens Clinic
  • All Childrens Hospital
  • St Josephs Childrens Hospital Tampa
  • Saint Marys Medical Center
  • Egleston Children'S Health
  • Kapiolani Medical Center For Women and Children
  • Ann & Robert H. Lurie Children'S Hospital
  • Loyola University Medical Center
  • Southern Illinois University School of Medicine
  • Riley Hospital For Children
  • St Vincent Hospital
  • Blank Childrens Hospital
  • University of Iowa Hospital and Clinics
  • University of Kentucky
  • Kosair Childrens Hospital
  • Ochsner Clinic
  • Maine Center For Cancer Medicine
  • Sinai Hospital of Baltimore
  • Johns Hopkins University
  • Dana Farber Boston Children'S
  • Cs Mott Childrens Hospital
  • Helen Devos Childrens Hosp
  • Michigan State University
  • University of Minnesota
  • Children'S Hospitals and Clinics of Minnesota
  • University of Mississippi Medical Center
  • The Children'S Mercy Hospital Outpatient
  • Washington University
  • Children'S Hospital & Medical Center
  • Alliance For Childhood Diseases
  • Children'S Center For Cancer & Blood Dis
  • Hackensack University Medical Center
  • Morristown Medical Center
  • Rutgers Cancer Institute of Nj
  • Newark Beth Israel Medical Center
  • St Josephs Regional Medical Center
  • University of New Mexico Hospital
  • Albany Medical College
  • Roswell Park Comprehensive Cancer Center
  • Cohen Children'S Medical Center
  • Weill Cornell Medical College
  • Nyu Clinical Cancer Center
  • University of Rochester Medical Center
  • Suny Upstate Medical University
  • New York Medical College
  • University of North Carolina At Chapel Hill
  • Carolinas Medical Center
  • Wake Forest University
  • Akron Children'S Hospital
  • Cincinnati Childrens Hospital Medical Center
  • Rainbow Babies & Children Hosp
  • Cleveland Clinic Foundation
  • Nationwide Children'S Hospital
  • Dayton Children'S Hospital
  • Toledo Hospital
  • University of Oklahoma Health Sciences Center
  • Legacy Emanuel Hospital and Health Center
  • Doernbecher Childrens Hospital
  • Penn State Hershey Medical Center
  • Children'S Hospital of Philadelphia
  • Childrens Hospital of Pittsburgh
  • Hasbro Childrens Hospital
  • Medical University of South Carolina
  • Vanderbilt University Medical Center
  • Dell Childrens Medical Center of Central Texas
  • Driscoll Children'S Hospital
  • Medical City Dallas Hospital
  • University of Texas Southwestern Medical Center
  • El Paso Children'S Hospital Corporation
  • Texas Childrens Hospital
  • University of Texas Health Science Cente
  • Primary Children'S Hospital
  • Children'S Hospital of the
  • Seattle Children'S Hospital
  • Providence Sacred Heart Medical Center & Children'S Hospital
  • St Vincent Hospital
  • Medical College of Wisconsin
  • Alberta'S Children Hospital
  • Bc Children'S Hospital
  • The Hospital For Sick Children
  • Chu Sainte-Justine
  • McGill University Health Centre/Glen Site/Cedars Cancer Centre
  • McMaster University Medical Centre
  • San Jorge Childrens Hospital
  • University Pediatric Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ruxolitinib in combination with chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 9, 2016
Last Updated
July 20, 2023
Sponsor
Incyte Corporation
Collaborators
Children's Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT02723994
Brief Title
A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2016 (Actual)
Primary Completion Date
November 28, 2025 (Anticipated)
Study Completion Date
November 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
Collaborators
Children's Oncology Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
B-cell acute lymphoblastic leukemia (ALL), pediatric, multi-agent chemotherapy, JAK inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ruxolitinib in combination with chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
Other Intervention Name(s)
INCB018424
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Asparaginase Erwinia Chrysanthemi
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Type
Drug
Intervention Name(s)
Leucovorin Calcium
Intervention Type
Drug
Intervention Name(s)
Mercaptopurine
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Type
Drug
Intervention Name(s)
Pegaspargase
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Type
Drug
Intervention Name(s)
Thioguanine
Intervention Type
Drug
Intervention Name(s)
Vincristine Sulfate
Primary Outcome Measure Information:
Title
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)
Title
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
Time Frame
Part 2: assessed at 3 years
Secondary Outcome Measure Information:
Title
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
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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 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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Assad, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sarah Tasian, MD
Organizational Affiliation
Children's Hospital of Philadelphia, Philadelphia, PA
Official's Role
Study Chair
Facility Information:
Facility Name
The Childrens Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Phoenix Children'S Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016-7710
Country
United States
Facility Name
Arkansas Childrens Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Kaiser Permanente
City
Fontana
State/Province
California
ZIP/Postal Code
92335
Country
United States
Facility Name
Loma Linda University Cancer Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Facility Name
Miller Childrens Hospital Pharmacy
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Children'S Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Kaiser Foundation Health Plan
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Valley Childrens Hospital
City
Madera
State/Province
California
ZIP/Postal Code
93636-8762
Country
United States
Facility Name
Choc Children Hospital
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Lucille Packard Childrens Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Kaiser Permanente
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Rady Children'S Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Ucsf Pediatric Oncology
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Kaiser Permanente Downey
City
Santa Fe Springs
State/Province
California
ZIP/Postal Code
90670
Country
United States
Facility Name
Children'S Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Connecticut Children'S Medical Ctr
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Smilow Cancer Center - Yale
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Alfred I. Dupont Hospital For Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Childrens Hospital of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
Joe Dimaggio Children Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Nemours Childrens Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Florida Health Shands Hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Florida Hospital Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Arnold Palmer Hospital For Children
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Nemours Childrens Clinic
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
All Childrens Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
St Josephs Childrens Hospital Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Saint Marys Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Egleston Children'S Health
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1060
Country
United States
Facility Name
Kapiolani Medical Center For Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Ann & Robert H. Lurie Children'S Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153-3328
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Riley Hospital For Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
St Vincent Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Blank Childrens Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Kosair Childrens Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Maine Center For Cancer Medicine
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-7049
Country
United States
Facility Name
Dana Farber Boston Children'S
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Cs Mott Childrens Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Helen Devos Childrens Hosp
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Michigan State University
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
University of Minnesota
City
Minneapolils
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Children'S Hospitals and Clinics of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
The Children'S Mercy Hospital Outpatient
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
Children'S Hospital & Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Alliance For Childhood Diseases
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Children'S Center For Cancer & Blood Dis
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Rutgers Cancer Institute of Nj
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
St Josephs Regional Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
University of New Mexico Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Roswell Park Comprehensive Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Cohen Children'S Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Nyu Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Suny Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
University of North Carolina At Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Akron Children'S Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Rainbow Babies & Children Hosp
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Nationwide Children'S Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Dayton Children'S Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Facility Name
Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Legacy Emanuel Hospital and Health Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Doernbecher Childrens Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-2360
Country
United States
Facility Name
Children'S Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Childrens Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Hasbro Childrens Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Dell Childrens Medical Center of Central Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Driscoll Children'S Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
El Paso Children'S Hospital Corporation
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Texas Childrens Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Cente
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Primary Children'S Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Children'S Hospital of the
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Seattle Children'S Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Providence Sacred Heart Medical Center & Children'S Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
St Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Alberta'S Children Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
Bc Children'S Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6G1R8
Country
Canada
Facility Name
The Hospital For Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
94611
Country
Canada
Facility Name
Chu Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
McGill University Health Centre/Glen Site/Cedars Cancer Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
McMaster University Medical Centre
City
Hamilton
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
San Jorge Childrens Hospital
City
San Juan
ZIP/Postal Code
00912
Country
Puerto Rico
Facility Name
University Pediatric Hospital
City
San Juan
ZIP/Postal Code
00930
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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