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Clinical Trials in China / NCT05660473
Recruiting Phase 2

Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia

NCT05660473 · tracked via the Priya Life Science China tracker
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 2
Started
2022-08-01
Last updated
2025-08-01

Condition(s) studied

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Investigational drug(s) / intervention(s)

Vincristine →Daunorubicin →Cyclophosphamide →Pegaspargase →Prednisone →Cytarabine →6-mercaptopurineDexamethasone →Methotrexate →Venetoclax →

Vincristine: Anti-tumor alkaloids

Daunorubicin: Anthracycline

Cyclophosphamide: Alkylating agent

Pegaspargase: Polyethylene glycol (PEG) conjugated to L-asparaginase

Prednisone: Glucocorticoids

Cytarabine: Pyrimidine antimetabolites

6-mercaptopurine: Cell cycle-specific antitumor drug

Dexamethasone: Glucocorticoids

Methotrexate: Antifolate antineoplastic drug

Venetoclax: Selective inhibitor of B-cell lymphoma 2 (Bcl-2)

Study summary

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.

Eligibility

Sex
ALL
Min age
14 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to WHO classification * Age: 14 -60 years * Male or female * ECOG Performance Status 0-2 * Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal(ULN); serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (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%; * Subject has provided written informed consent prior to any screening procedure Exclusion Criteria: * Burkitt lymphoma/leukemia * Acute Leukemia of Ambiguous Lineage * Female patients who are pregnant or breast feeding * Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment * History of pancreatitis * Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of \>7.5%. Patients with preexisting, well-controlled diabetes are not excluded * History of active gastrointestinal bleeding within the last 6 months * History of arterial/venous thrombosis within the last 6 months * Known HIV seropositivity * Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institute of Hematology & Blood Diseases Hospital Tianjin China Recruiting

On this site

📄 Deltasone (prednisone) drug profile → 📄 Venclexta (venetoclax) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05660473 on ClinicalTrials.gov ↗ ← All trials in China