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 (NCT06317662)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Alabama — Birmingham, Alabama
Age range: Not specified to 365 Days
🧪 Interventions in This Study
- Asparaginase Erwinia chrysanthemi (DRUG)
- Blinatumomab (BIOLOGICAL)
- Calaspargase Pegol (DRUG)
- Cyclophosphamide (DRUG)
- Cytarabine (DRUG)
- Daunorubicin (DRUG)
- Dexamethasone (DRUG)
- Doxorubicin (DRUG)
- Leucovorin (DRUG)
- Levoleucovorin (DRUG)
- Mercaptopurine (DRUG)
- Methotrexate (DRUG)
- Methylprednisolone (DRUG)
- Prednisolone (DRUG)
- Prednisone (DRUG)
- Therapeutic Hydrocortisone (DRUG)
- Thioguanine (DRUG)
- Venetoclax (DRUG)
- Vincristine (DRUG)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (114 Sites)
Showing the first 25 of 114 sites.
- Children's Hospital of Alabama — Birmingham, Alabama
- Providence Alaska Medical Center — Anchorage, Alaska
- Banner Children's at Desert — Mesa, Arizona
- Arkansas Children's Hospital — Little Rock, Arkansas
- Loma Linda University Medical Center — Loma Linda, California
- Miller Children's and Women's Hospital Long Beach — Long Beach, California
- UCSF Benioff Children's Hospital Oakland — Oakland, California
- Kaiser Permanente-Oakland — Oakland, California
- Children's Hospital of Orange County — Orange, California
- University of California Davis Comprehensive Cancer Center — Sacramento, California
- UCSF Medical Center-Mission Bay — San Francisco, California
- Children's Hospital Colorado — Aurora, Colorado
- Connecticut Children's Medical Center — Hartford, Connecticut
- Yale University — New Haven, Connecticut
- Alfred I duPont Hospital for Children — Wilmington, Delaware
- Children's National Medical Center — Washington D.C., District of Columbia
- UF Health Cancer Institute - Gainesville — Gainesville, Florida
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida
- Nemours Children's Clinic-Jacksonville — Jacksonville, Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida
- AdventHealth Orlando — Orlando, Florida
- Arnold Palmer Hospital for Children — Orlando, Florida
- Nemours Children's Hospital — Orlando, Florida
- Nemours Children's Clinic - Pensacola — Pensacola, Florida
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida
📞 Contact the Study Coordinator
Phone: (205) 638-9285
Email: oncologyresearch@peds.uab.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.