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Study details
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Venetoclax and a Pediatric-Inspired Regimen for Newly Diagnosed B Cell Acute Lymphoblastic Leukemia

City of Hope Medical Center
NCT IDNCT05157971ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1

Target enrollment

24

Study length

about 3.9 years

Ages

18–54

Locations

1 site in CA

About this study

This trial is testing the safety, side effects, and best dose of venetoclax in combination with a pediatric-inspired chemotherapy regimen called C10403 to treat patients with newly diagnosed B cell acute lymphoblastic leukemia. Venetoclax may stop cancer cells from growing by blocking Bcl-2, a protein needed for survival. The C10403 regimen includes several chemotherapy drugs that work in different ways to kill or prevent the growth of cancer cells, along with prednisone, an anti-inflammatory drug used to lower the body's immune response.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Cyclophosphamide
  • 2.Take Cytarabine
  • 3.Take Daunorubicin Hydrochloride
  • +3 more
PhasePhase 1
DrugCyclophosphamide
Routeinfusion
Primary goalDose limiting toxicity

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low15%
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

cyclophosphamide (Alkylating chemotherapy; crosslinks DNA strands), cytarabine, Antineoplastic Agent [TC] (DNA Polymerase Inhibitors), mercaptopurine, methotrexate, pegaspargase, prednisone, venetoclax

Drug routes

infusion, injection (Injection), oral (Oral Tablet), oral

Endpoints

Primary: Dose limiting toxicity, Incidence of adverse events

Secondary: Complete response (CR) after consolidation, Complete response (CR) after consolidation for Philadelphia (Ph)-like acute lymphoblastic leukemia (ALL), Complete response (CR) after induction +/- extended induction, Complete response (CR) after induction +/- extended induction for Philadelphia (Ph)-like acute lymphoblastic leukemia (ALL), Composite complete response (CR) (CR/ CR with incomplete hematologic recovery [CRi]/ CR with partial hematologic recovery [CRh]) after induction +/- extended induction, Composite complete response (CR) (CR/ CR with incomplete hematologic recovery [CRi]/ CR with partial hematologic recovery [CRh]) after induction +/- extended induction for Philadelphia (Ph)-like acute lymphoblastic leukemia (ALL), Overall survival

Body systems

Oncology