Venetoclax and Blinatumomab for Infants with Leukemia

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

Recruiting Phase 2 Interventional Study
Acute Leukemia of Ambiguous Lineage B Acute Lymphoblastic Leukemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
Up to 365 Days
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
153 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for infants who have just been diagnosed with a specific type of leukemia. Participants will receive standard chemotherapy along with additional treatments to see if they work better together.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am an infant aged 365 days or less at the time of diagnosis.
  • I have been diagnosed with B-acute lymphoblastic leukemia or acute leukemia of ambiguous lineage.
  • I have leukemia cells that express CD19.
  • I have been enrolled in APEC14B1 and consented to eligibility screening.
  • I am older than 36 weeks gestational age.

You may not be able to join if

  • I have Down Syndrome.
  • I have previously received chemotherapy for another cancer.
  • I have taken any cytotoxic chemotherapy for my leukemia before starting this trial.
  • I have taken dexamethasone within the 28 days before starting this trial.
  • I have had an intrathecal dose of cytarabine or methotrexate in the 7 days before enrollment.
  • I have taken hydroxyurea for more than 72 hours in the 7 days before enrollment.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 o…
Trial Locations
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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…
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