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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

171

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

February 1, 2026

Study Completion Date

February 1, 2026

Conditions
Leukemia
Interventions
DRUG

Ruxolitinib

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.

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

Trial Locations (111)

10021

Weill Cornell Medical College, New York

10032

Nyu Clinical Cancer Center, New York

10595

New York Medical College, Valhalla

11040

Cohen Children'S Medical Center, New Hyde Park

12208

Albany Medical College, Albany

13210

Suny Upstate Medical University, Syracuse

14263

Roswell Park Comprehensive Cancer Center, Buffalo

14642

University of Rochester Medical Center, Rochester

15224

Childrens Hospital of Pittsburgh, Pittsburgh

19104

Children'S Hospital of Philadelphia, Philadelphia

19803

Alfred I. Dupont Hospital For Children, Wilmington

21215

Sinai Hospital of Baltimore, Baltimore

23507

Children'S Hospital of the, Norfolk

27157

Wake Forest University, Winston-Salem

27514

University of North Carolina At Chapel Hill, Chapel Hill

28203

Carolinas Medical Center, Charlotte

29425

Medical University of South Carolina, Charleston

32207

Nemours Childrens Clinic, Jacksonville

32209

University of Florida Health Shands Hospital, Jacksonville

32504

Nemours Childrens Clinic, Pensacola

32803

Florida Hospital Orlando, Orlando

32806

Arnold Palmer Hospital For Children, Orlando

33021

Joe Dimaggio Children Hospital, Hollywood

33407

Saint Marys Medical Center, West Palm Beach

33607

St Josephs Childrens Hospital Tampa, Tampa

33701

All Childrens Hospital, St. Petersburg

33908

Childrens Hospital of Southwest Florida, Fort Myers

35233

The Childrens Hospital of Alabama, Birmingham

37232

Vanderbilt University Medical Center, Nashville

39216

University of Mississippi Medical Center, Jackson

40202

Kosair Childrens Hospital, Louisville

40536

University of Kentucky, Lexington

43205

Nationwide Children'S Hospital, Columbus

43606

Toledo Hospital, Toledo

44106

Rainbow Babies & Children Hosp, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

44308

Akron Children'S Hospital, Akron

45229

Cincinnati Childrens Hospital Medical Center, Cincinnati

45404

Dayton Children'S Hospital, Dayton

46202

Riley Hospital For Children, Indianapolis

46260

St Vincent Hospital, Indianapolis

48109

Cs Mott Childrens Hospital, Ann Arbor

48912

Michigan State University, Lansing

49503

Helen Devos Childrens Hosp, Grand Rapids

50309

Blank Childrens Hospital, Des Moines

52242

University of Iowa Hospital and Clinics, Iowa City

53226

Medical College of Wisconsin, Milwaukee

54301

St Vincent Hospital, Green Bay

55404

Children'S Hospitals and Clinics of Minnesota, Minneapolis

55455

University of Minnesota, Minneapolis

60611

Ann & Robert H. Lurie Children'S Hospital, Chicago

62702

Southern Illinois University School of Medicine, Springfield

63130

Washington University, St Louis

64108

The Children'S Mercy Hospital Outpatient, Kansas City

68114

Children'S Hospital & Medical Center, Omaha

70121

Ochsner Clinic, New Orleans

72202

Arkansas Childrens Hospital, Little Rock

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75230

Medical City Dallas Hospital, Dallas

75390

University of Texas Southwestern Medical Center, Dallas

77030

Texas Childrens Hospital, Houston

78229

University of Texas Health Science Cente, San Antonio

78411

Driscoll Children'S Hospital, Corpus Christi

78723

Dell Childrens Medical Center of Central Texas, Austin

79905

El Paso Children'S Hospital Corporation, El Paso

80045

Children'S Hospital Colorado, Aurora

84113

Primary Children'S Hospital, Salt Lake City

87131

University of New Mexico Hospital, Albuquerque

89109

Alliance For Childhood Diseases, Las Vegas

Children'S Center For Cancer & Blood Dis, Las Vegas

90027

Children'S Hospital Los Angeles, Los Angeles

Kaiser Foundation Health Plan, Los Angeles

Southern California Permanente Medical Group, Los Angeles

90670

Kaiser Permanente Downey, Santa Fe Springs

90806

Miller Childrens Hospital Pharmacy, Long Beach

92111

Kaiser Permanente, San Diego

92123

Rady Children'S Hospital - San Diego, San Diego

92335

Kaiser Permanente, Fontana

92350

Loma Linda University Cancer Center, Loma Linda

92868

Choc Children Hospital, Orange

94158

Ucsf Pediatric Oncology, San Francisco

94304

Lucille Packard Childrens Hospital, Palo Alto

94611

The Hospital For Sick Children, Toronto

96826

Kapiolani Medical Center For Women and Children, Honolulu

97227

Legacy Emanuel Hospital and Health Center, Portland

97239

Doernbecher Childrens Hospital, Portland

98105

Seattle Children'S Hospital, Seattle

99204

Providence Sacred Heart Medical Center & Children'S Hospital, Spokane

85016-7710

Phoenix Children'S Hospital, Phoenix

93636-8762

Valley Childrens Hospital, Madera

06106

Connecticut Children'S Medical Ctr, Hartford

06510

Smilow Cancer Center - Yale, New Haven

30322-1060

Egleston Children'S Health, Atlanta

60153-3328

Loyola University Medical Center, Maywood

04074

Maine Center For Cancer Medicine, Scarborough

21287-7049

Johns Hopkins University, Baltimore

02215

Dana Farber Boston Children'S, Boston

07601

Hackensack University Medical Center, Hackensack

07962

Morristown Medical Center, Morristown

08901

Rutgers Cancer Institute of Nj, New Brunswick

07112

Newark Beth Israel Medical Center, Newark

07503

St Josephs Regional Medical Center, Paterson

17033-2360

Penn State Hershey Medical Center, Hershey

02903

Hasbro Childrens Hospital, Providence

T3B 6A8

Alberta'S Children Hospital, Calgary

V6G1R8

Bc Children'S Hospital, Vancouver

H3T 1C5

Chu Sainte-Justine, Montreal

H4A 3J1

McGill University Health Centre/Glen Site/Cedars Cancer Centre, Montreal

L8V 5C2

McMaster University Medical Centre, Hamilton

00930

University Pediatric Hospital, San Juan

00912

San Jorge Childrens Hospital, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Children's Oncology Group

NETWORK

lead

Incyte Corporation

INDUSTRY