Actively Recruiting
Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
153
Participants Needed
108
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged \[R\]) or without a KMT2A gene rearrangement (KMT2A-germline \[G\]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.
CONDITIONS
Official Title
Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be enrolled on APEC14B1 and consented to eligibility screening before treatment
- Infants must be 365 days old or younger at diagnosis and more than 36 weeks gestational age at enrollment
- Newly diagnosed with B-acute lymphoblastic leukemia or acute leukemia of ambiguous lineage with at least 50% B lineage
- Leukemia cells must express CD19
- Informed consent must be signed by patients or legal guardians
- All FDA, NCI, and institutional human study requirements must be met
You will not qualify if you...
- Patients with Down Syndrome
- Patients with secondary B-ALL after prior treatment with cytotoxic chemotherapy
- Patients who received any cytotoxic chemotherapy before starting protocol therapy except:
- Steroid pretreatment with prednisone, prednisolone, or methylprednisolone for 72 hours or less within 7 days before enrollment
- Inhaled or topical steroids do not affect eligibility
- Dexamethasone use within 28 days before protocol therapy is not allowed except a single dose around sedation
- Intrathecal cytarabine or methotrexate within 7 days before enrollment is allowed
- Hydroxyurea use for 72 hours or less within 7 days before enrollment is allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 108 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
Actively Recruiting
3
Banner Children's at Desert
Mesa, Arizona, United States, 85202
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
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
8
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Actively Recruiting
9
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
10
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
11
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
12
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
13
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
14
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
15
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
16
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
17
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
18
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Actively Recruiting
19
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
20
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
21
AdventHealth Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
22
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
23
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Actively Recruiting
24
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
Actively Recruiting
25
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
26
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States, 33607
Actively Recruiting
27
Saint Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Actively Recruiting
28
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
29
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Actively Recruiting
30
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States, 83712
Actively Recruiting
31
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Suspended
32
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States, 60453
Actively Recruiting
33
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, United States, 60068
Actively Recruiting
34
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
35
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
36
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
37
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
38
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
Actively Recruiting
39
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
Actively Recruiting
40
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074
Actively Recruiting
41
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
42
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
43
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
44
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01655
Actively Recruiting
45
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
46
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
47
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Actively Recruiting
48
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
49
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
50
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
51
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
52
Mercy Hospital Saint Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
53
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
Actively Recruiting
54
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
55
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
56
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
57
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
58
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States, 07503
Actively Recruiting
59
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
60
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
61
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
Actively Recruiting
62
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
63
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
64
NYP/Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
65
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
66
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
67
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
68
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
69
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
70
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
71
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
72
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
73
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Actively Recruiting
74
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
75
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
76
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
Actively Recruiting
77
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
78
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
79
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
80
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
81
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
82
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
83
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
84
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
85
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
Actively Recruiting
86
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
87
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States, 37916
Actively Recruiting
88
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
89
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, United States, 37203
Actively Recruiting
90
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
91
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Actively Recruiting
92
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Actively Recruiting
93
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Actively Recruiting
94
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
95
El Paso Children's Hospital
El Paso, Texas, United States, 79905
Actively Recruiting
96
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
97
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
98
Children's Hospital of San Antonio
San Antonio, Texas, United States, 78207
Actively Recruiting
99
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
Actively Recruiting
100
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
101
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
Actively Recruiting
102
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
103
Carilion Children's
Roanoke, Virginia, United States, 24014
Actively Recruiting
104
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
105
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Actively Recruiting
106
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
107
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
108
University Pediatric Hospital
San Juan, Puerto Rico, 00926
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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