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

Summary

The purpose of this phase 2 study is to test blinatumomab in combination with chemotherapy for infants with newly diagnosed acute lymphoblastic leukemia, with randomization of patients with KMT2A-rearranged disease to receive the addition of venetoclax.

This phase 2 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 or without a KMT2A gene rearrangement. 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 or without KMT2A gene rearrangement.

To be included in AALL2321, participants must be / have

• Must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to treatment and enrollment on AALL2321.
• Age:
  • Infants (aged 365 days or less) on the date of diagnosis
  • Infants must be > 36 weeks gestational age at the time of enrollment.
• Diagnosis:
  • Patients must have newly diagnosed B-acute lymphoblastic leukemia, which includes mixed phenotype acute leukemia.
  • Diagnostic immunophenotype: Leukemia cells must express CD19

To be included in AALL2321, participants must not be / have 

• Patients with down syndrome
• Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy
• Prior therapy: 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

Keywords
Leukemia