Back to search results

Testing Venetoclax and Blinatumomab for Infant Leukemia

This study is testing if adding venetoclax and/or blinatumomab to standard chemotherapy helps infants with newly diagnosed acute lymphoblastic leukemia (ALL). Venetoclax works by blocking a protein called Bcl-2, which cancer cells need to survive. Blinatumomab is a monoclonal antibody (a type of immune therapy) that may stop cancer cells from growing and spreading. Researchers want to see if these additions are safe and if they improve how well the chemotherapy works, specifically by reducing the amount of leukemia cells remaining after treatment. The study is for infants aged 365 days or less with newly diagnosed B-ALL. The goal is to enroll 153 participants. This study is currently recruiting, but its overall status is unclear.

Study design
This interventional study plans to enroll 153 infants. It will compare different treatment approaches, including adding venetoclax and/or blinatumomab to usual chemotherapy.
What's involved
You would undergo blood sample collections, bone marrow aspirations, and receive study drugs like Asparaginase Erwinia chrysanthemi, Blinatumomab, and Calaspargase Pegol.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured during induction and venetoclax cycles, and throughout induction, consolidation, and MARMA cycles for some participants. Remission rates are measured at the end of induction.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06317662

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
PHASE2All AgesInterventionalTreatment
National Cancer Institute (NCI)
~153 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Asparaginase Erwinia chrysanthemiBiospecimen CollectionBlinatumomabBone Marrow AspirationCalaspargase PegolComputed Tomography

At a glance

Recruiting sites
113 of 114 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose-limiting toxicities (DLTs) (safety phase)
Measured over For the duration of the induction + venetoclax cycle
+2 more outcomes measured

Conditions

Acute Leukemia of Ambiguous Lineage
B Acute Lymphoblastic Leukemia

Explore related trials

Acute Leukemia of Ambiguous LineageB Acute Lymphoblastic LeukemiaCD19 Gene

Where it's being run

114 sites across 44 states
Florida11
New York10
Texas9
California7
Illinois6
North Carolina5
Ohio5
New Jersey4

Study leadership

  • Erin H Breese · PRINCIPAL_INVESTIGATOR · Children's Oncology Group

Who to contact

Site Public Contact
[email protected]
205-638-9285
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of dose-limiting toxicities (DLTs) (safety phase)For the duration of the induction + venetoclax cycle

    For the safety phase, DLTs of the induction + venetoclax cycle of KMT2A-rearranged (R) patients will be assessed.

  • Incidence of DLTs (expansion phase)During the induction, consolidation, and MARMA cycles of Arm B

    For the expansion phase, DLTs of Arm B will be assessed and monitored for the cycles that contain venetoclax (induction, consolidation, and MARMA cycles of Arm B).

  • Minimal residual disease (MRD)-negative remission rateAt the end of induction

    The end of induction MRD-negative remission rate will be compared between Arm A and Arm B. MRD negativity is defined as achievement of complete remission and MRD \< 0.01% by flow cytometry. The MRD-negative remission rate at the end of induction between Arm A and Arm B will be compared using a one-sided Z test of proportions with Type I error of 0.15.