Combining venetoclax and blinatumomab with standard chemotherapy for infants with acute leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to standard chemotherapy for infants diagnosed with acute lymphoblastic leukemia (ALL) that either has a KMT2A gene rearrangement or does not. Venetoclax is a Bcl-2 inhibitor that may help stop cancer cell growth, while blinatumomab is a monoclonal antibody that targets cancer cells. The study aims to determine if this combination improves remission rates and event-free survival compared to standard chemotherapy alone. It also assesses the pharmacokinetics of venetoclax in infants and explores the feasibility of treating different subtypes of leukemia.

Why it matters

Who can join: the full rules

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 met

Where it's running

• Children's Hospital of Alabama
  Birmingham, Alabama, United States Recruiting
• Providence Alaska Medical Center
  Anchorage, Alaska, United States Recruiting
• Banner Children's at Desert
  Mesa, Arizona, United States Recruiting
• Arkansas Children's Hospital
  Little Rock, Arkansas, United States Recruiting
• Loma Linda University Medical Center
  Loma Linda, California, United States Recruiting
• Miller Children's and Women's Hospital Long Beach
  Long Beach, California, United States Recruiting

+67 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Erin H Breese — Children's Oncology Group

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.