Actively Recruiting
An International Phase 2 Study of Chemotherapy and Tyrosine Kinase Inhibitors With Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-Class Philadelphia Chromosome-Like B-Cell Acute Lymphoblastic Leukemia
Led by National Cancer Institute (NCI) · Updated on 2026-06-03
222
Participants Needed
150
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment involving blinatumomab with either dasatinib or imatinib alongside standard chemotherapy for patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-cell acute lymphoblastic leukemia (B-ALL). This phase 2 trial focuses on children, adolescents, and young adults under 25 years old, aiming to improve event-free survival while monitoring safety and toxicity of this novel chemo-immunotherapy approach with continuous tyrosine kinase inhibitor (TKI). Treatment varies by patient group (stratum) based on genetic features. Patients receive multiple cycles including induction chemotherapy, blinatumomab infusions, and continuous oral dasatinib or imatinib, combined with intrathecal and intravenous chemotherapy agents such as methotrexate, vincristine, and pegaspargase. Some may also undergo radiation therapy. The treatment is structured into induction parts, blinatumomab blocks, interim maintenance, delayed intensification, and maintenance cycles, repeated over approximately two years unless disease progression or toxicity occurs. Participants undergo regular assessments including echocardiography or MUGA scans, blood and cerebrospinal fluid sample collection, and bone marrow biopsies throughout the study. Researchers measure event-free survival, overall survival, minimal residual disease levels, and adverse events such as infections and neurotoxicity over a three-year period. The study also investigates immune function, drug levels in plasma and cerebrospinal fluid, and the impact of drug interactions on treatment outcomes.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Patients must be older than 365 days and younger than 18 years (AIEOP-BFM), younger than 22 years (Children's Oncology Group), or younger than 46 years (ALLTogether sites) at enrollment
- Newly diagnosed Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like B-ALL with leukemic blasts expressing CD19
- Documented BCR::ABL1 or ABL-class Ph-like gene rearrangements by clinically validated assays before study entry
- For Ph+ B-ALL, prior start of induction therapy including vincristine, corticosteroids, and pegaspargase or calaspargase pegol with or without anthracycline
- For Ph+ B-ALL, no more than 14 days of systemic induction therapy starting with first vincristine dose
- For ABL-class Ph-like B-ALL, completion of 4-5 weeks of multiagent induction chemotherapy
- Received no more than 14 days of TKI for Ph+ B-ALL or 35 days for ABL-class Ph-like B-ALL before study entry
- Performance status with ECOG ≤ 2 or Karnofsky/Lansky score ≥ 50%
- Kidney function: GFR ≥ 50 mL/min/1.73 m2 (pediatrics) or creatinine clearance ≥ 30 mL/min (adults) within specified timeframes
- Liver function: direct bilirubin < 2.0 mg/dL and ALT/AST ≤ 10 x upper limit of normal within 7 days before enrollment
- Heart function: shortening fraction ≥ 27% by echocardiogram or left ventricular ejection fraction ≥ 50%, and QTc < 480 mSec within 21 days before enrollment
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
- Acute lymphoblastic leukemia developing after prior cancer treatment with cytotoxic chemotherapy
- Active uncontrolled infection or systemic illness requiring vasopressors or mechanical ventilation
- Down syndrome (trisomy 21)
- Pregnancy or breastfeeding; females must have negative pregnancy test and sexually active participants must use effective contraception
- Prior treatment with tyrosine kinase inhibitors except imatinib or dasatinib
- Congenital long QT syndrome, ventricular arrhythmias, or heart block
- Known Charcot-Marie-Tooth disease
- Significant central nervous system pathology preventing blinatumomab treatment, including severe neurologic or autoimmune CNS disorders
- HIV-infected patients not on effective antiretroviral therapy or with detectable viral load
- Failure to provide informed consent or meet institutional, FDA, and NCI requirements for human studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for echocardiography or MUGA and baseline assessments
Duration - Up to 4 weeks
Participants receive initial chemotherapy and tyrosine kinase inhibitors as per their assigned stratum to begin treatment of their leukemia.
Multiple visits during first 4 weeks for chemotherapy and drug administration
Duration - Approximately 15 weeks (3 cycles of 5 weeks each)
Participants receive three sequential 5-week cycles of blinatumomab with concurrent tyrosine kinase inhibitors and intrathecal methotrexate to target leukemia cells.
Repeated visits for 3 cycles of 5 weeks each with IV blinatumomab and oral tyrosine kinase inhibitors
Duration - Approximately 17 weeks (9 weeks Interim Maintenance I and 8 weeks Interim Maintenance II)
Participants receive tyrosine kinase inhibitors alongside chemotherapy agents including methotrexate, mercaptopurine, and vincristine over two maintenance phases to sustain treatment response.
Weekly and periodic visits over approximately 17 weeks for chemotherapy and drug administration
Duration - Approximately 9 weeks
Participants receive intensified chemotherapy combined with tyrosine kinase inhibitors over two parts to further reduce leukemia cells.
Frequent visits for chemotherapy infusions and oral medications over 9 weeks
Duration - Up to 2 years
Participants continue long-term treatment with tyrosine kinase inhibitors and chemotherapy cycles repeated every 12 weeks for up to 2 years to maintain remission.
Visits every 12 weeks for cycles involving oral and intravenous medications
Trial Site Locations
Total: 150 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
Kaiser Permanente Downey Medical Center
Downey, California, United States, 90242
Actively Recruiting
6
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Actively Recruiting
7
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States, 90806
Actively Recruiting
8
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
9
Valley Children's Hospital
Madera, California, United States, 93636
Actively Recruiting
10
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
11
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Actively Recruiting
12
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
13
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
14
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
15
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
Actively Recruiting
16
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
17
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
18
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
19
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
20
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
21
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
22
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
23
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Actively Recruiting
24
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
25
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Actively Recruiting
26
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
27
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
28
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
29
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Actively Recruiting
30
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
Actively Recruiting
31
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
32
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States, 33607
Actively Recruiting
33
Saint Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Actively Recruiting
34
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
35
Augusta University Medical Center
Augusta, Georgia, United States, 30912
Actively Recruiting
36
Atrium Health Navicent
Macon, Georgia, United States, 31201
Actively Recruiting
37
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Actively Recruiting
38
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Actively Recruiting
39
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States, 83712
Actively Recruiting
40
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
41
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
42
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
43
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States, 60453
Actively Recruiting
44
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, United States, 60068
Actively Recruiting
45
OSF Children's Hospital of Illinois
Peoria, Illinois, United States, 61637
Actively Recruiting
46
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
47
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
48
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Actively Recruiting
49
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
50
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
51
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
Actively Recruiting
52
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074
Actively Recruiting
53
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
54
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
55
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
Actively Recruiting
56
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
57
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01655
Actively Recruiting
58
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
59
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Actively Recruiting
60
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
61
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Actively Recruiting
62
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
63
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
64
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
65
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
66
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
67
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
68
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
Actively Recruiting
69
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States, 89135
Actively Recruiting
70
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
71
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
72
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
73
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
74
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States, 07503
Actively Recruiting
75
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
76
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
77
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
78
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
79
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
Actively Recruiting
80
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
81
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
82
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
83
NYP/Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
84
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Actively Recruiting
85
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
86
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
87
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
88
Mission Hospital
Asheville, North Carolina, United States, 28801
Actively Recruiting
89
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
90
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
91
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
92
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
93
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
94
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Actively Recruiting
95
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
96
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
97
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
98
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
Actively Recruiting
99
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
100
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
101
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
102
Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
103
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
104
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Actively Recruiting
105
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
106
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
107
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
108
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
Actively Recruiting
109
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
110
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States, 37916
Actively Recruiting
111
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, United States, 37203
Actively Recruiting
112
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
113
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Actively Recruiting
114
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Actively Recruiting
115
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Actively Recruiting
116
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
117
El Paso Children's Hospital
El Paso, Texas, United States, 79905
Actively Recruiting
118
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
119
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
120
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
Actively Recruiting
121
UMC Cancer Center / UMC Health System
Lubbock, Texas, United States, 79415
Actively Recruiting
122
Children's Hospital of San Antonio
San Antonio, Texas, United States, 78207
Actively Recruiting
123
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
Actively Recruiting
124
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
125
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
126
University of Vermont and State Agricultural College
Burlington, Vermont, United States, 05405
Actively Recruiting
127
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
128
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Actively Recruiting
129
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
Actively Recruiting
130
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
131
Carilion Children's
Roanoke, Virginia, United States, 24014
Actively Recruiting
132
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
133
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Actively Recruiting
134
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States, 98405
Actively Recruiting
135
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
136
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
137
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
138
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
139
Perth Children's Hospital
Perth, Western Australia, Australia, 6009
Actively Recruiting
140
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
141
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Suspended
142
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Actively Recruiting
143
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
144
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Actively Recruiting
145
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
146
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada, H3H 1P3
Actively Recruiting
147
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
148
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
149
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec, Canada, G1V 4G2
Actively Recruiting
150
University Pediatric Hospital
San Juan, Puerto Rico, 00926
Actively Recruiting
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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