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Study details
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Testing the Addition of Venetoclax and/or Blinatumomab to Chemotherapy for Infants with Newly Diagnosed Leukemia

National Cancer Institute (NCI)
NCT IDNCT06317662ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2

Target enrollment

153

Study length

about 3.6 years

Ages

≤0.999336057550805

Locations

106 sites in AK, AL, AR +37

About this study

Researchers are testing whether adding venetoclax and/or blinatumomab to usual chemotherapy treatment improves outcomes in infants diagnosed with acute lymphoblastic leukemia (ALL) who have a KMT2A gene rearrangement or not. The trial will evaluate the safety and effectiveness of this combination therapy compared to standard chemotherapy alone.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Receive Blinatumomab
  • 2.Take Asparaginase Erwinia chrysanthemi
  • 3.Take Calaspargase Pegol
  • +3 more
PhasePhase 2
DrugAsparaginase Erwinia chrysanthemi
Routeinjection

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low7%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS, blinatumomab, calaspargase pegol, cyclophosphamide (Alkylating chemotherapy; crosslinks DNA strands), cytarabine, daunorubicin, dexamethasone, doxorubicin (Anthracycline chemotherapy; intercalates DNA and inhibits topoisomerase II)

Drug routes

injection (Injection), injection, intravenous, infusion, ocular, oral (Oral Tablet), oral (Disintegrating Oral Tablet), oral

Endpoints

Secondary: 3-year EFS of infants with KMT2A-G ALL treated on Arm C, 3-year EFS of infants with KMT2A-R ALL, Event free survival (EFS) rates of infants with KMT2A-R ALL, Pharmacokinetics (PK) of venetoclax in infants

Procedures

diagnostic, biopsy, imaging

Body systems

Oncology