OncoMatch/Clinical Trials/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
Is NCT06317662 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for acute leukemia of ambiguous lineage.
Treatment: Asparaginase Erwinia chrysanthemi · Blinatumomab · Calaspargase Pegol · Cyclophosphamide · Cytarabine · Daunorubicin · Dexamethasone · Doxorubicin · Leucovorin · Levoleucovorin · Mercaptopurine · Methotrexate · Methylprednisolone · Prednisolone · Prednisone · Therapeutic Hydrocortisone · Thioguanine · Venetoclax · Vincristine — 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 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 KMT2A-R or KMT2A-G ALL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 expression
Leukemia cells must express CD19
Allowed: KMT2A (MLL) rearrangement
KMT2A-rearranged or KMT2A-non-rearranged leukemia
Allowed: KMT2A (MLL) non-rearranged
KMT2A-rearranged or KMT2A-non-rearranged leukemia
Prior therapy
Cannot have received: cytotoxic chemotherapy
Exception: Steroid pretreatment (prednisone, prednisolone, methylprednisolone) ≤ 72 hours in the 7 days prior to enrollment; inhaled/topical steroids; single dose dexamethasone for airway edema; intrathecal cytarabine or methotrexate in the 7 days prior to enrollment; hydroxyurea ≤ 72 hours in the 7 days prior to enrollment
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: [see above]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital of Alabama · Birmingham, Alabama
- Providence Alaska Medical Center · Anchorage, Alaska
- Banner Children's at Desert · Mesa, Arizona
- Arkansas Children's Hospital · Little Rock, Arkansas
- Loma Linda University Medical Center · Loma Linda, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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