Actively Recruiting
Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia
Led by City of Hope Medical Center · Updated on 2026-03-05
24
Participants Needed
1
Research Sites
216 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial tests the safety, side effects, and best dose of venetoclax in combination with a pediatric-inspired chemotherapy regimen known as C10403 in treating patients with newly diagnosed B cell acute lymphoblastic leukemia. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. The C10403 regimen is composed of the chemotherapy drugs cytarabine, cyclophosphamide, daunorubicin, mercaptopurine, pegaspargase, vincristine, and methotrexate, all which 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. It also consists of prednisone, which is an anti-inflammatory drug that lowers the body's immune response and is used with other drugs in the treatment of some types of some types of cancer. This study may help researchers learn if adding venetoclax to the pediatric-inspired C10403 regimen can be tolerated and help treat older patients.
CONDITIONS
Official Title
Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legally authorized representative has given informed consent
- Age is between 18 and 54 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Histologically confirmed B cell acute lymphoblastic leukemia (ALL) with bone marrow involvement
- Newly diagnosed disease with at least 5% blasts in the bone marrow
- White blood cell count less than 25 x 10^9/L before starting venetoclax
- Liver function tests (bilirubin, AST, ALT) within defined limits unless related to leukemia or Gilbert's disease
- Creatinine clearance of 60 mL/min or higher
- Left ventricular ejection fraction (LVEF) 50% or higher
- For women of childbearing potential: negative pregnancy test and agreement to use effective birth control or abstain from heterosexual activity during the study and for 3 months after
- Agreement by males of childbearing potential to use effective birth control or abstain from heterosexual activity during the study and for 3 months after
You will not qualify if you...
- Previous leukemia therapy except for cytoreduction with steroids, hydroxyurea, or a single dose of intrathecal chemotherapy before study start
- Use of strong or moderate CYP3A4 inducers within 14 days before treatment
- Consumption of grapefruit, Seville oranges, star fruit, or related products within 3 days before first study drug dose
- Receipt of live vaccines
- Presence of Philadelphia chromosome positive (Ph+), MLL-rearrangement, t(12;21), or t(1;19) leukemia types
- Diagnosis of T cell ALL
- Severe cardiovascular disability (Class III/IV NYHA) or unstable arrhythmias
- Central nervous system involvement requiring cranial radiation
- Recent acute cardiovascular ischemic events within 6 months
- History of allergic reactions to similar compounds as study drugs
- Clinically significant uncontrolled illness or active infection
- Other active cancers
- Pregnant or breastfeeding females
- Any condition or factor that the investigator judges would make participation unsafe or compliance difficult
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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