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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
RecruitingPhase 2
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
Who can join
365 Days · All sexes
Full eligibility criteria
Inclusion Criteria:
* 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 (cumulative prenatal and postnatal age must be \> 36 weeks) 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
Exclusion Criteria:
* Patients with Down Syndrome
* Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy
* Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy, with the exception of:
* Steroid pretreatment:
* PredniSONE, prednisoLONE, or methylPREDNISolone for ≤ 72 hours (3 days) in the 7 days prior to enrollment. The dose of predniSONE, prednisoLONE or methylPREDNISolone does not affect eligibility
* Inhaled and topical steroids are not considered pretreatment
* Note: Pretreatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone used during or within 6 hours prior to or after sedation to prevent or treat airway edema. However, prior exposure to ANY steroids that occurred \> 28 days before enrollment does not affect eligibility
* Intrathecal cytarabine or methotrexate:
* An intrathecal dose of cytarabine or methotrexate in the 7 days prior to enrollment does not affect eligibility
* Note: The preference is to defer the diagnostic lumbar puncture with intrathecal chemotherapy to day 1 of induction to allow for cytoreduction of circulating blasts and decrease the potential for central nervous system (CNS) contamination due to a traumatic tap. If done prior to day 1 of induction, these results will be used to determine CNS status
* Hydroxyurea:
* Pretreatment with ≤ 72 hours (3 days) of hydroxyurea in the 7 days prior to enrollment does not affect eligibility
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be metAbout the study
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.
What is being tested
- Asparaginase Erwinia chrysanthemi (drug)
- Biospecimen Collection (procedure)
- Blinatumomab (biological)
- Bone Marrow Aspiration (procedure)
- Calaspargase Pegol (drug)
- Computed Tomography (procedure)
Sponsor: National Cancer Institute (NCI) · Participants: 153 · Started: Jun 5, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT06317662
Locations in the U.S.
| Alabama | Children's Hospital of Alabama, Birmingham |
| Alaska | Providence Alaska Medical Center, Anchorage |
| Arizona | Banner Children's at Desert, Mesa |
| Arkansas | Arkansas Children's Hospital, Little Rock |
| California | Loma Linda University Medical Center, Loma Linda Miller Children's and Women's Hospital Long Beach, Long Beach Kaiser Permanente-Oakland, Oakland UCSF Benioff Children's Hospital Oakland, Oakland Children's Hospital of Orange County, Orange University of California Davis Comprehensive Cancer Center, Sacramento UCSF Medical Center-Mission Bay, San Francisco |
| Colorado | Children's Hospital Colorado, Aurora |
| Connecticut | Yale University, New Haven |
| Delaware | Alfred I duPont Hospital for Children, Wilmington |
| District of Columbia | Children's National Medical Center, Washington D.C. |
| Florida | UF Health Cancer Institute - Gainesville, Gainesville Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood Nemours Children's Clinic-Jacksonville, Jacksonville University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami AdventHealth Orlando, Orlando Arnold Palmer Hospital for Children, Orlando Nemours Children's Hospital, Orlando Nemours Children's Clinic - Pensacola, Pensacola Johns Hopkins All Children's Hospital, St. Petersburg Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa Saint Mary's Medical Center, West Palm Beach |
| Georgia | Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta |
| Hawaii | Kapiolani Medical Center for Women and Children, Honolulu |
| Idaho | Saint Luke's Cancer Institute - Boise, Boise |
| Illinois | Lurie Children's Hospital-Chicago, Chicago University of Chicago Comprehensive Cancer Center, Chicago Advocate Children's Hospital-Oak Lawn, Oak Lawn Advocate Children's Hospital-Park Ridge, Park Ridge OSF Children's Hospital of Illinois, Peoria Southern Illinois University School of Medicine, Springfield |
| Indiana | Riley Hospital for Children, Indianapolis |
| Iowa | Blank Children's Hospital, Des Moines |
| Kentucky | University of Kentucky/Markey Cancer Center, Lexington Norton Children's Hospital, Louisville |
| Louisiana | Children's Hospital New Orleans, New Orleans Ochsner Medical Center Jefferson, New Orleans |
| Maine | Maine Children's Cancer Program, Scarborough |
| Maryland | Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore Sinai Hospital of Baltimore, Baltimore |
| Massachusetts | Dana-Farber Cancer Institute, Boston UMass Memorial Medical Center - University Campus, Worcester |
| Michigan | C S Mott Children's Hospital, Ann Arbor Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids Bronson Methodist Hospital, Kalamazoo |
| Minnesota | University of Minnesota/Masonic Cancer Center, Minneapolis |
| Mississippi | University of Mississippi Medical Center, Jackson |
| Missouri | Children's Mercy Hospitals and Clinics, Kansas City Mercy Hospital Saint Louis, St Louis Washington University School of Medicine, St Louis |
| Nebraska | Children's Hospital and Medical Center of Omaha, Omaha |
| Nevada | Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas |
| New Hampshire | Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon |
| New Jersey | Hackensack University Medical Center, Hackensack Morristown Medical Center, Morristown Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick Saint Joseph's Regional Medical Center, Paterson |
| New York | Albany Medical Center, Albany Roswell Park Cancer Institute, Buffalo The Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York Memorial Sloan Kettering Cancer Center, New York NYP/Weill Cornell Medical Center, New York University of Rochester, Rochester State University of New York Upstate Medical University, Syracuse Montefiore Medical Center - Moses Campus, The Bronx New York Medical College, Valhalla |
| North Carolina | UNC Lineberger Comprehensive Cancer Center, Chapel Hill Carolinas Medical Center/Levine Cancer Institute, Charlotte Duke University Medical Center, Durham East Carolina University, Greenville Wake Forest University Health Sciences, Winston-Salem |
| North Dakota | Sanford Broadway Medical Center, Fargo |
| Ohio | Children's Hospital Medical Center of Akron, Akron Cincinnati Children's Hospital Medical Center, Cincinnati Rainbow Babies and Childrens Hospital, Cleveland Dayton Children's Hospital, Dayton ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo |
| Oklahoma | University of Oklahoma Health Sciences Center, Oklahoma City |
| Pennsylvania | Lehigh Valley Hospital-Cedar Crest, Allentown Geisinger Medical Center, Danville Penn State Children's Hospital, Hershey Children's Hospital of Philadelphia, Philadelphia Children's Hospital of Pittsburgh of UPMC, Pittsburgh |
| Rhode Island | Rhode Island Hospital, Providence |
| South Carolina | Prisma Health Richland Hospital, Columbia BI-LO Charities Children's Cancer Center, Greenville |
| South Dakota | Sanford USD Medical Center - Sioux Falls, Sioux Falls |
| Tennessee | East Tennessee Childrens Hospital, Knoxville Saint Jude Children's Research Hospital, Memphis The Children's Hospital at TriStar Centennial, Nashville Vanderbilt University/Ingram Cancer Center, Nashville |
| Texas | Dell Children's Medical Center of Central Texas, Austin Driscoll Children's Hospital, Corpus Christi Medical City Dallas Hospital, Dallas UT Southwestern/Simmons Cancer Center-Dallas, Dallas El Paso Children's Hospital, El Paso Cook Children's Medical Center, Fort Worth Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston Children's Hospital of San Antonio, San Antonio Methodist Children's Hospital of South Texas, San Antonio Scott and White Memorial Hospital, Temple |
| Virginia | University of Virginia Cancer Center, Charlottesville Children's Hospital of The King's Daughters, Norfolk VCU Massey Comprehensive Cancer Center, Richmond Carilion Children's, Roanoke |
| Washington | Seattle Children's Hospital, Seattle Providence Sacred Heart Medical Center and Children's Hospital, Spokane |
| Wisconsin | Saint Vincent Hospital Cancer Center Green Bay, Green Bay Children's Hospital of Wisconsin, Milwaukee |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.