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Recruiting NCT05660473

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

Phase II Interventional Precursor Cell Lymphoblastic Leukemia-Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vincristine, Daunorubicin, Cyclophosphamide, Pegaspargase.
Who it may be relevant to
Registry conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma. Basic parameters: 14 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Vincristine
    Anti-tumor alkaloids
  • Drug Daunorubicin
    Anthracycline
  • Drug Cyclophosphamide
    Alkylating agent
  • Drug Pegaspargase
    Polyethylene glycol (PEG) conjugated to L-asparaginase
  • Drug Prednisone
    Glucocorticoids
  • Drug Cytarabine
    Pyrimidine antimetabolites
  • Drug 6-mercaptopurine
    Cell cycle-specific antitumor drug
  • Drug Dexamethasone
    Glucocorticoids
  • Drug Methotrexate
    Antifolate antineoplastic drug
  • Drug Venetoclax
    Selective inhibitor of B-cell lymphoma 2 (Bcl-2)

Primary outcome measures

  • MRD-negative complete remission rate measured by flow cytometry [Time frame: After induction (4 week)]
Secondary outcome measures (5)
  • Complete remission (CR) rate [Time frame: After 2 cycles of chemotherapy, an expected average of 3 months]
  • Overall survival (OS) [Time frame: Up to 5 years post-registration]
  • Relapse free survival (RFS) [Time frame: Up to 5 years post-registration]
  • Disease-free Survival (DFS) [Time frame: Up to 5 years post-registration]
  • The rate of adverse events [Time frame: An expected average of 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Institute of Hematology & Blood Diseases Hospital — Tianjin

Publications

  • Gong X, Liu Y, Fang Q, Gu R, Liu K, Lin D, Zhou C, Zhang G, Gong B, Wei S, Li Y, Li S, Wang Y, Qiu S, Liu B, Wang Y, Mi Y, Wei H, Wang J. Venetoclax Plus Pediatric Regimen in Adolescents and Adults with Ph-Negative Acute Lymphoblastic Leukemia. Blood. 2026 May 21:blood.2026033577. doi: 10.1182/blood.2026033577. Online ahead of print. PMID 42166560

Identifiers

NCT: NCT05660473 · IIT2022052

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗