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 (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05660473 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require BCR?
Yes, BCR fusion is a required biomarker for enrollment.
Does this trial require ABL1?
Yes, ABL1 fusion is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 60 years or younger and at least 14 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify