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



Status:Recruiting
Conditions:Blood Cancer, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - 21
Updated:11/1/2018
Start Date:August 2016
End Date:May 2024
Contact:Incyte Corporation Call Center
Phone:1.855.463.3463

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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.


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

- Systemic steroid pretreatment without presteroid WBC documentation

- One of the following Ph-like ALL genetic lesions must be present in the diagnostic
bone marrow or peripheral blood sample:

- CRLF2 rearrangement with JAK1 or JAK2 mutation (JAK+)

- CRLF2 rearrangement without JAK mutation

- Other JAK pathway alterations (eg, JAK2 fusions, erythropoietin receptor (EPO-R)
fusions, SH2B3 deletions, interleukin-7 receptor-alpha (IL7RA) mutations) with or
without CRLF2 rearrangement

- Completed a 4-drug Induction therapy regimen (modified aBFM regimen or equivalent) in
Study AALL1131 or as 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
We found this trial at
101
sites
601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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Ann Arbor, MI 48109Bus: -
Ann Arbor, Michigan 48109
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Children's Hospital of Alabama Children
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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1200 Pleasant Street
Des Moines, Iowa 50309
(515) 241-KIDS
Blank Children's Hospital Blank Children's Hospital is completely dedicated to meeting the unique health care...
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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1000 Joe DiMaggio Drive
Hollywood, Florida 33021
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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231 E Chestnut St
Louisville, Kentucky 40202
(502) 629-6000
Kosair Children's Hospital For more than a century, Kosair Children's Hospital and its predecessor hospitals...
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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100 N Mario Capecchi Dr
Salt Lake City, Utah 84132
(801) 662-1000
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
New York Medical College The College was founded in 1860 by a group of New...
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Anaheim, California 92806
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28203
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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9500 Euclid Avenue
Cleveland, Ohio 44195
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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El Paso, Texas 79905
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9961 Sierra Ave
Fontana, California 92335
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Grand Rapids, Michigan 49503
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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Hershey, Pennsylvania 17033
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1319 Punahou Street
Honolulu, Hawaii 96826
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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2001 West 86th Street
Indianapolis, Indiana 46260
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Kalamazoo, Michigan 49007
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409 West Circle Drive
Lansing, Michigan 48910
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Las Vegas, Nevada 89109
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Loma Linda, California 92354
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2801 Atlantic Avenue
Long Beach, California 90806
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Los Angeles, California 90027
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Madera, California 93638
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Minneapolis, Minnesota 55404
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Morristown, New Jersey 07962
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New Brunswick, New Jersey 08903
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New Hyde Park, New York 11042
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New York, New York 10021
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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8200 Dodge Street
Omaha, Nebraska 68114
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Orlando, Florida 32806
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Orlando, Florida 32806
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Palo Alto, California 94304
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Paterson, New Jersey 07503
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Pensacola, Florida 32504
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
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Portland, Oregon 97239
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2801 N Gantenbein Ave
Portland, Oregon 97227
(503) 413-2200
Legacy Emanuel Hospital and Health Center Legacy Emanuel is nationally known for expertise in critical...
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Providence, Rhode Island 02903
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Saint Louis, Missouri 63110
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Saint Petersburg, Florida 33701
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4647 Zion Avenue
San Diego, California 92120
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San Diego, California 92123
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400 Parnassus Avenue
San Francisco, California 94143
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Scarborough, Maine 04074
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South Brisbane, Queensland 4101
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801 N Rutledge St
Springfield, Illinois 62702
(217) 545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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750 East Adams Street
Syracuse, New York 13210
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2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-5437
The Toledo Hospital/Toledo Children's Hospital ProMedica's Mission is to improve your health and well-being. And...
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Wauwatosa, Wisconsin 53226
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901 45th St
West Palm Beach, Florida 33407
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