A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

Status: Recruiting
Location: See all (75) locations...
Intervention Type: Procedure, Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: f
View:

• All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrollment on AALL2321

• Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be \> 36 weeks gestational age at the time of enrollment

• Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 World Health Organization \[WHO\] classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage

⁃ Diagnostic immunophenotype: Leukemia cells must express CD19

Locations
United States
Alaska
Providence Alaska Medical Center
RECRUITING
Anchorage
Arkansas
Arkansas Children's Hospital
RECRUITING
Little Rock
California
Loma Linda University Medical Center
RECRUITING
Loma Linda
Kaiser Permanente-Oakland
RECRUITING
Oakland
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Connecticut
Connecticut Children's Medical Center
RECRUITING
Hartford
Washington, D.c.
Children's National Medical Center
RECRUITING
Washington D.c.
Delaware
Alfred I duPont Hospital for Children
RECRUITING
Wilmington
Florida
University of Florida Health Science Center - Gainesville
RECRUITING
Gainesville
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
RECRUITING
Hollywood
Nemours Children's Clinic-Jacksonville
RECRUITING
Jacksonville
AdventHealth Orlando
RECRUITING
Orlando
Nemours Children's Hospital
RECRUITING
Orlando
Saint Joseph's Hospital/Children's Hospital-Tampa
RECRUITING
Tampa
Georgia
Children's Healthcare of Atlanta - Arthur M Blank Hospital
RECRUITING
Atlanta
Idaho
Saint Luke's Cancer Institute - Boise
RECRUITING
Boise
Illinois
Lurie Children's Hospital-Chicago
RECRUITING
Chicago
Southern Illinois University School of Medicine
RECRUITING
Springfield
Indiana
Riley Hospital for Children
RECRUITING
Indianapolis
Kentucky
University of Kentucky/Markey Cancer Center
RECRUITING
Lexington
Norton Children's Hospital
RECRUITING
Louisville
Louisiana
Children's Hospital New Orleans
RECRUITING
New Orleans
Ochsner Medical Center Jefferson
RECRUITING
New Orleans
Massachusetts
UMass Memorial Medical Center - University Campus
RECRUITING
Worcester
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
RECRUITING
Baltimore
Sinai Hospital of Baltimore
RECRUITING
Baltimore
Maine
Maine Children's Cancer Program
RECRUITING
Scarborough
Michigan
C S Mott Children's Hospital
RECRUITING
Ann Arbor
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
RECRUITING
Grand Rapids
Bronson Methodist Hospital
RECRUITING
Kalamazoo
Minnesota
University of Minnesota/Masonic Cancer Center
RECRUITING
Minneapolis
Missouri
Children's Mercy Hospitals and Clinics
RECRUITING
Kansas City
Mercy Hospital Saint Louis
RECRUITING
St Louis
Mississippi
University of Mississippi Medical Center
RECRUITING
Jackson
North Carolina
Carolinas Medical Center/Levine Cancer Institute
RECRUITING
Charlotte
East Carolina University
RECRUITING
Greenville
Wake Forest University Health Sciences
RECRUITING
Winston-salem
Nebraska
Children's Hospital and Medical Center of Omaha
RECRUITING
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITING
Lebanon
New Jersey
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
RECRUITING
New Brunswick
Saint Joseph's Regional Medical Center
RECRUITING
Paterson
New York
Albany Medical Center
RECRUITING
Albany
Roswell Park Cancer Institute
RECRUITING
Buffalo
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
Montefiore Medical Center - Moses Campus
RECRUITING
The Bronx
New York Medical College
RECRUITING
Valhalla
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Rainbow Babies and Childrens Hospital
RECRUITING
Cleveland
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
RECRUITING
Toledo
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
RECRUITING
Allentown
Geisinger Medical Center
RECRUITING
Danville
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Children's Hospital of Pittsburgh of UPMC
RECRUITING
Pittsburgh
South Carolina
Prisma Health Richland Hospital
RECRUITING
Columbia
BI-LO Charities Children's Cancer Center
RECRUITING
Greenville
South Dakota
Sanford USD Medical Center - Sioux Falls
RECRUITING
Sioux Falls
Tennessee
East Tennessee Childrens Hospital
RECRUITING
Knoxville
Saint Jude Children's Research Hospital
RECRUITING
Memphis
The Children's Hospital at TriStar Centennial
RECRUITING
Nashville
Vanderbilt University/Ingram Cancer Center
RECRUITING
Nashville
Texas
Dell Children's Medical Center of Central Texas
RECRUITING
Austin
Medical City Dallas Hospital
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
RECRUITING
Dallas
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
RECRUITING
Houston
Children's Hospital of San Antonio
RECRUITING
San Antonio
Methodist Children's Hospital of South Texas
RECRUITING
San Antonio
Virginia
University of Virginia Cancer Center
RECRUITING
Charlottesville
Children's Hospital of The King's Daughters
RECRUITING
Norfolk
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
RECRUITING
Spokane
Wisconsin
Saint Vincent Hospital Cancer Center Green Bay
RECRUITING
Green Bay
Children's Hospital of Wisconsin
RECRUITING
Milwaukee
Other Locations
Puerto Rico
University Pediatric Hospital
RECRUITING
San Juan
Time Frame
Start Date: 2025-06-05
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 153
Treatments
Experimental: Arm A
See Detailed Description for Arm A.
Experimental: Arm B, Cohort 1
See Detailed Description for Arm B, Cohort 1.
Experimental: Arm B, Cohort 2
See Detailed Description for Arm B, Cohort 2.
Experimental: Arm B, Cohort 3
See Detailed Description for Arm B, Cohort 3.
Experimental: Arm B, Cohort 4
See Detailed Description for Arm B, Cohort 4.
Experimental: Arm C
See Detailed Description for Arm C.
Experimental: Safety Phase Cohort
See Detailed Description for Safety Phase Cohort.
Experimental: Steroid Prephase(prednisone, prednisolone, methylprednisolone)
All patients receive prednisone or prednisolone PO or NG TID or methylprednisolone IV TID for 7 days prior to the start of induction therapy (on days 1-7).
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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