OncoMatch/Clinical Trials/NCT05157971
Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia
Is NCT05157971 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for b acute lymphoblastic leukemia.
Treatment: Cyclophosphamide · Cytarabine · Daunorubicin Hydrochloride · Mercaptopurine · Methotrexate · Pegaspargase · Prednisone · Venetoclax · Vincristine Sulfate — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Excluded: BCR t(9;22)
Philadelphia chromosome positive (Ph+; t(9;22))
Excluded: KMT2A (MLL) rearrangement
MLL-rearrangement
Excluded: ETV6 t(12;21)
t(12;21)
Excluded: TCF3 t(1;19)
t(1;19)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Exception: Cytoreduction with steroid or hydroxyurea or a single dose of intrathecal chemotherapy is allowed before initiating the study
Leukemia-based therapy with chemotherapy with the exception of: Cytoreduction with steroid or hydroxyurea or a single dose of intrathecal chemotherapy is allowed before initiating the study
Lab requirements
Kidney function
Creatinine clearance of >= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Liver function
Total bilirubin <= 1.5 X ULN (unless has Gilbert's disease or underlying leukemia, <= 3 X ULN); AST <= 2.5 x ULN; ALT <= 2.5 x ULN (unless related to underlying leukemia)
Cardiac function
Left ventricular ejection fraction (LVEF) >= 50%
Total bilirubin <= 1.5 X ULN (unless has Gilbert's disease or underlying leukemia, <= 3 X ULN) AST <= 2.5 x ULN ALT <= 2.5 x ULN Creatinine clearance of >= 60 mL/min Left ventricular ejection fraction (LVEF) >= 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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