OncoMatch/Clinical Trials/NCT05660473
Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia
Is NCT05660473 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for precursor cell lymphoblastic leukemia-lymphoma.
Treatment: Vincristine · Daunorubicin · Cyclophosphamide · Pegaspargase · Prednisone · Cytarabine · 6-mercaptopurine · Dexamethasone · Methotrexate · Venetoclax — The pediatric-inspired regimen has greatly improved the prognosis of adult patients with with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), but relapse remains a great challenge. Venetoclax (Ven) is an oral, selective inhibitor of B-cell lymphoma 2 (Bcl-2). Although this drug is currently used primarily for acute myeloid leukemia, in vitro as well as small cohort studies suggest a effect in acute lymphoblastic leukemia. This study proposes to combine pediatric-inspired regimen with venetoclax for the treatment of adult patients with Ph- ALL, aiming to improve the MRD-negative complete remission rate measured by flow cytometry after induction and to reduce relapse, thus further improving patients overall survival.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: BCR fusion
Ph/BCR-ABL1 negative
Required: ABL1 fusion
Ph/BCR-ABL1 negative
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Kidney function
Creatinine ≤ 1.5 x ULN
Liver function
Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related
Cardiac function
Ejection fraction ≥ 45% by cardiac color Doppler ultrasound
Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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