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
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Palo Alto, California 94304
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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
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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
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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 
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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
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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
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 (323) 660-2450
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231 E Chestnut St
Louisville, Kentucky 40202
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Kosair Children's Hospital For more than a century, Kosair Children's Hospital and its predecessor hospitals...
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Minneapolis, Minnesota 55455
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1211 Medical Center Dr
Nashville, Tennessee 37232
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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1201 W La Veta Ave
Orange, California 92868
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
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100 N Mario Capecchi Dr
Salt Lake City, Utah 84132
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4502 Medical Drive
San Antonio, Texas 78284
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
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Albuquerque, New Mexico 87131
(505) 277-0111
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Anaheim, California 92806
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13123 E 16th Ave
Aurora, Colorado 80045
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300 Longwood Ave
Boston, Massachusetts 02115
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charlotte, North Carolina 28203
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225 E Chicago Ave
Chicago, Illinois 60611
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2035 W Taylor St
Chicago, Illinois
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9500 Euclid Avenue
Cleveland, Ohio 44195
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
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El Paso, Texas 79905
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Fontana, California 92335
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Grand Rapids, Michigan 49503
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30 Prospect Ave
Hackensack, New Jersey 07601
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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
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
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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
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
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Loma Linda, California 92354
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2801 Atlantic Avenue
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
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New Brunswick, New Jersey 08903
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20 York St, N20 York St,
New Haven, Connecticut 06520
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New Hyde Park, New York 11042
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630 W 168th St
New York, New York
212-305-2862
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201 Lyons Ave
Newark, New Jersey 07112
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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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Pensacola, Florida 32504
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1919 E Thomas Rd
Phoenix, Arizona 85006
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
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2801 N Gantenbein Ave
Portland, Oregon 97227
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Providence, Rhode Island 02903
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San Diego, California 92120
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San Francisco, California 94143
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801 N Rutledge St
Springfield, Illinois 62702
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Syracuse, New York 13210
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2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-5437
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Wauwatosa, Wisconsin 53226
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901 45th St
West Palm Beach, Florida 33407
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