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

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

Trial Details

NCT ID
NCT06317662
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Asparaginase Erwinia chrysanthemi
  • Biospecimen Collection
  • Blinatumomab
  • Bone Marrow Aspiration
  • Calaspargase Pegol
  • Computed Tomography
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Mesa, Arizona, United States|33.42227,-111.82264
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Loma Linda, California, United States|34.04835,-117.26115

Key Eligibility 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 postnat…
  • Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 World Health Organization \[WHO\] classification), also termed B-pre…
  • Diagnostic immunophenotype: Leukemia cells must express CD19

For full eligibility, visit ClinicalTrials.gov.

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