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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 ID: NCT02723994
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.
Detailed Description:
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
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, Saint 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, Saint 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
San Jorge Childrens Hospital, San Juan, , Puerto Rico
University Pediatric Hospital, San Juan, , Puerto Rico
Name: Albert Assad, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
Name: Sarah Tasian, MD
Affiliation: Children's Hospital of Philadelphia, Philadelphia, PA
Role: STUDY_CHAIR