Actively Recruiting

Phase 2
Age: 366Days - 46Years
All Genders
NCT06124157

A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

222

Participants Needed

146

Research Sites

287 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib and imatinib are in a class of medications called tyrosine kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib or imatinib in combination with standard chemotherapy may work better in treating patients with Ph+ or Ph-like ABL-class B-ALL than dasatinib or imatinib with chemotherapy.

CONDITIONS

Official Title

A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)

Who Can Participate

Age: 366Days - 46Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must be older than 365 days and younger than 18, 22, or 46 years depending on the study site
  • Newly diagnosed with Ph+ or ABL-class Ph-like B-ALL with leukemic blasts expressing CD19
  • Evidence of BCR::ABL1 documented by clinically-validated assay before day 15 of induction therapy
  • ABL-class Ph-like B-ALL gene rearrangements documented by clinically-validated assay before day 1 of Blinatumomab Block 1
  • Ph+ B-ALL patients must have started induction therapy including vincristine, corticosteroids, pegaspargase or calaspargase pegol, with or without anthracycline
  • Ph+ B-ALL patients must have received no more than 14 days of systemic induction therapy
  • ABL-class Ph-like B-ALL patients must have completed 4 or 5 weeks of multiagent induction chemotherapy
  • Patients may have started imatinib or dasatinib before study entry but no more than 14 days for Ph+ B-ALL or 35 days for ABL-class Ph-like B-ALL
  • Performance status of ECOG score 62; 2 or Karnofsky/Lansky score 62; 50%
  • Pediatric patients must have a glomerular filtration rate (GFR) 62; 50 mL/min/1.73 m2 within 7 days prior to enrollment
  • Adult patients must have creatinine clearance 62; 30 mL/min within 28 days prior to registration
  • Direct bilirubin less than 2.0 mg/dL within 7 days prior to enrollment
  • ALT and AST less than or equal to 10 times upper limit of normal within 7 days prior to enrollment
  • Adequate heart function shown by shortening fraction 62; 27% or left ventricular ejection fraction 62; 50% and corrected QT interval less than 480mSec within 21 days prior to enrollment
Not Eligible

You will not qualify if you...

  • Known history of chronic myeloid leukemia (CML)
  • ABL-class Ph-like B-ALL patients who are CNS2 or CNS3 at end of induction phase
  • Acute lymphoblastic leukemia developing after a previous cancer treated with cytotoxic chemotherapy
  • Active, uncontrolled infection or systemic illness requiring vasopressor support or mechanical ventilation
  • Down syndrome (trisomy 21)
  • Pregnancy or breastfeeding
  • Female patients who are pregnant or lactating
  • Sexually active patients who have not agreed to use effective contraception during treatment and specified follow-up periods
  • Prior treatment with tyrosine kinase inhibitors other than imatinib or dasatinib
  • Patients with congenital long QT syndrome, history of ventricular arrhythmias, or heart block
  • Patients with Charcot-Marie-Tooth disease
  • Patients with significant central nervous system disorders that prevent treatment with blinatumomab, except well-controlled seizures
  • HIV-infected patients not on effective antiretroviral therapy or with detectable viral load within 6 months
  • Failure to provide written informed consent or meet institutional, FDA, and NCI human studies requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 146 locations

1

Children's Hospital of Alabama

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Phoenix Childrens Hospital

Phoenix, Arizona, United States, 85016

Actively Recruiting

3

Banner University Medical Center - Tucson

Tucson, Arizona, United States, 85719

Actively Recruiting

4

Arkansas Children's Hospital

Little Rock, Arkansas, United States, 72202-3591

Actively Recruiting

5

Loma Linda University Medical Center

Loma Linda, California, United States, 92354

Actively Recruiting

6

Miller Children's and Women's Hospital Long Beach

Long Beach, California, United States, 90806

Actively Recruiting

7

Children's Hospital Los Angeles

Los Angeles, California, United States, 90027

Actively Recruiting

8

Valley Children's Hospital

Madera, California, United States, 93636

Actively Recruiting

9

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States, 94609

Actively Recruiting

10

Kaiser Permanente-Oakland

Oakland, California, United States, 94611

Actively Recruiting

11

Children's Hospital of Orange County

Orange, California, United States, 92868

Actively Recruiting

12

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, United States, 94304

Actively Recruiting

13

Rady Children's Hospital - San Diego

San Diego, California, United States, 92123

Actively Recruiting

14

UCSF Medical Center-Mission Bay

San Francisco, California, United States, 94158

Actively Recruiting

15

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

16

Connecticut Children's Medical Center

Hartford, Connecticut, United States, 06106

Actively Recruiting

17

Yale University

New Haven, Connecticut, United States, 06520

Actively Recruiting

18

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States, 19803

Actively Recruiting

19

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

20

Children's National Medical Center

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

21

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States, 33908

Actively Recruiting

22

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States, 32610

Actively Recruiting

23

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States, 33021

Actively Recruiting

24

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, United States, 32207

Actively Recruiting

25

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States, 33136

Actively Recruiting

26

Arnold Palmer Hospital for Children

Orlando, Florida, United States, 32806

Actively Recruiting

27

Nemours Children's Hospital

Orlando, Florida, United States, 32827

Actively Recruiting

28

Nemours Children's Clinic - Pensacola

Pensacola, Florida, United States, 32504

Actively Recruiting

29

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States, 33701

Actively Recruiting

30

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, United States, 33607

Actively Recruiting

31

Saint Mary's Medical Center

West Palm Beach, Florida, United States, 33407

Actively Recruiting

32

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, United States, 30329

Actively Recruiting

33

Augusta University Medical Center

Augusta, Georgia, United States, 30912

Actively Recruiting

34

Atrium Health Navicent

Macon, Georgia, United States, 31201

Actively Recruiting

35

Memorial Health University Medical Center

Savannah, Georgia, United States, 31404

Actively Recruiting

36

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States, 96826

Actively Recruiting

37

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States, 83712

Actively Recruiting

38

Lurie Children's Hospital-Chicago

Chicago, Illinois, United States, 60611

Suspended

39

University of Illinois

Chicago, Illinois, United States, 60612

Actively Recruiting

40

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States, 60637

Actively Recruiting

41

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, United States, 60453

Actively Recruiting

42

Advocate Children's Hospital-Park Ridge

Park Ridge, Illinois, United States, 60068

Actively Recruiting

43

Saint Jude Midwest Affiliate

Peoria, Illinois, United States, 61637

Actively Recruiting

44

Southern Illinois University School of Medicine

Springfield, Illinois, United States, 62702

Actively Recruiting

45

Riley Hospital for Children

Indianapolis, Indiana, United States, 46202

Actively Recruiting

46

Blank Children's Hospital

Des Moines, Iowa, United States, 50309

Actively Recruiting

47

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States, 52242

Actively Recruiting

48

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States, 40536

Actively Recruiting

49

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States, 70121

Actively Recruiting

50

Maine Children's Cancer Program

Scarborough, Maine, United States, 04074

Actively Recruiting

51

Sinai Hospital of Baltimore

Baltimore, Maryland, United States, 21215

Actively Recruiting

52

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States, 21287

Actively Recruiting

53

Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20889-5600

Actively Recruiting

54

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

55

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, United States, 01655

Actively Recruiting

56

C S Mott Children's Hospital

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

57

Children's Hospital of Michigan

Detroit, Michigan, United States, 48201

Actively Recruiting

58

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

59

Bronson Methodist Hospital

Kalamazoo, Michigan, United States, 49007

Actively Recruiting

60

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, United States, 55404

Actively Recruiting

61

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

62

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

63

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

Actively Recruiting

64

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States, 64108

Actively Recruiting

65

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

66

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, United States, 68114

Actively Recruiting

67

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, United States, 89135

Actively Recruiting

68

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

69

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Actively Recruiting

70

Morristown Medical Center

Morristown, New Jersey, United States, 07960

Actively Recruiting

71

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States, 08903

Actively Recruiting

72

Saint Joseph's Regional Medical Center

Paterson, New Jersey, United States, 07503

Actively Recruiting

73

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States, 87106

Actively Recruiting

74

Albany Medical Center

Albany, New York, United States, 12208

Actively Recruiting

75

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Actively Recruiting

76

NYU Langone Hospital - Long Island

Mineola, New York, United States, 11501

Actively Recruiting

77

The Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, United States, 11040

Actively Recruiting

78

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States, 10016

Actively Recruiting

79

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States, 10032

Actively Recruiting

80

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

81

NYP/Weill Cornell Medical Center

New York, New York, United States, 10065

Actively Recruiting

82

Stony Brook University Medical Center

Stony Brook, New York, United States, 11794

Actively Recruiting

83

State University of New York Upstate Medical University

Syracuse, New York, United States, 13210

Actively Recruiting

84

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States, 10467

Actively Recruiting

85

New York Medical College

Valhalla, New York, United States, 10595

Actively Recruiting

86

Mission Hospital

Asheville, North Carolina, United States, 28801

Actively Recruiting

87

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States, 28203

Actively Recruiting

88

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

89

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

90

Sanford Broadway Medical Center

Fargo, North Dakota, United States, 58122

Actively Recruiting

91

Children's Hospital Medical Center of Akron

Akron, Ohio, United States, 44308

Actively Recruiting

92

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

93

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, United States, 44106

Actively Recruiting

94

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

95

Dayton Children's Hospital

Dayton, Ohio, United States, 45404

Actively Recruiting

96

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, United States, 43606

Actively Recruiting

97

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

98

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States, 18103

Actively Recruiting

99

Penn State Children's Hospital

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

100

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

101

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States, 19134

Actively Recruiting

102

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

103

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Actively Recruiting

104

Prisma Health Richland Hospital

Columbia, South Carolina, United States, 29203

Actively Recruiting

105

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, United States, 29605

Actively Recruiting

106

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States, 57117-5134

Actively Recruiting

107

East Tennessee Childrens Hospital

Knoxville, Tennessee, United States, 37916

Actively Recruiting

108

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, United States, 37203

Actively Recruiting

109

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

110

Dell Children's Medical Center of Central Texas

Austin, Texas, United States, 78723

Actively Recruiting

111

Driscoll Children's Hospital

Corpus Christi, Texas, United States, 78411

Actively Recruiting

112

Medical City Dallas Hospital

Dallas, Texas, United States, 75230

Actively Recruiting

113

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States, 75390

Actively Recruiting

114

El Paso Children's Hospital

El Paso, Texas, United States, 79905

Actively Recruiting

115

Cook Children's Medical Center

Fort Worth, Texas, United States, 76104

Actively Recruiting

116

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

117

Covenant Children's Hospital

Lubbock, Texas, United States, 79410

Actively Recruiting

118

UMC Cancer Center / UMC Health System

Lubbock, Texas, United States, 79415

Actively Recruiting

119

Children's Hospital of San Antonio

San Antonio, Texas, United States, 78207

Actively Recruiting

120

Methodist Children's Hospital of South Texas

San Antonio, Texas, United States, 78229

Actively Recruiting

121

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

122

Primary Children's Hospital

Salt Lake City, Utah, United States, 84113

Actively Recruiting

123

University of Vermont and State Agricultural College

Burlington, Vermont, United States, 05405

Actively Recruiting

124

University of Virginia Cancer Center

Charlottesville, Virginia, United States, 22908

Actively Recruiting

125

Inova Fairfax Hospital

Falls Church, Virginia, United States, 22042

Actively Recruiting

126

Children's Hospital of The King's Daughters

Norfolk, Virginia, United States, 23507

Actively Recruiting

127

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States, 23298

Actively Recruiting

128

Carilion Children's

Roanoke, Virginia, United States, 24014

Actively Recruiting

129

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

130

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, United States, 99204

Actively Recruiting

131

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, United States, 98405

Actively Recruiting

132

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States, 54301

Actively Recruiting

133

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States, 53792

Actively Recruiting

134

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

135

Queensland Children's Hospital

South Brisbane, Queensland, Australia, 4101

Actively Recruiting

136

Perth Children's Hospital

Perth, Western Australia, Australia, 6009

Actively Recruiting

137

Alberta Children's Hospital

Calgary, Alberta, Canada, T3B 6A8

Actively Recruiting

138

British Columbia Children's Hospital

Vancouver, British Columbia, Canada, V6H 3V4

Suspended

139

IWK Health Centre

Halifax, Nova Scotia, Canada, B3K 6R8

Actively Recruiting

140

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, Canada, L8N 3Z5

Actively Recruiting

141

Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1X8

Actively Recruiting

142

The Montreal Children's Hospital of the MUHC

Montreal, Quebec, Canada, H3H 1P3

Actively Recruiting

143

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada, H3T 1C5

Actively Recruiting

144

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec, Canada, J1H 5N4

Actively Recruiting

145

CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

Québec, Canada, G1V 4G2

Actively Recruiting

146

University Pediatric Hospital

San Juan, Puerto Rico, 00926

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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