RecruitingPhase 2NCT05660473

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


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

100 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 14 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a drug called venetoclax to a standard intensive chemotherapy regimen improves outcomes for teenagers and adults newly diagnosed with a type of acute leukemia (ALL) that does not carry the Philadelphia chromosome mutation. **You may be eligible if...** - You are 14–60 years old - You have a new diagnosis of Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) - You have not received any prior treatment for this leukemia - You are in reasonably good health (ECOG 0–2) - Your liver, kidney, pancreas, and heart function meet the study requirements **You may NOT be eligible if...** - You have Burkitt lymphoma/leukemia or a mixed-lineage leukemia - You are pregnant or breastfeeding - You have poorly controlled diabetes (HbA1c above 7.5%) - You have a recent history of severe bleeding, blood clots, or active infections - You are HIV positive - You have a history of pancreatitis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVincristine

Anti-tumor alkaloids

DRUGDaunorubicin

Anthracycline

DRUGCyclophosphamide

Alkylating agent

DRUGPegaspargase

Polyethylene glycol (PEG) conjugated to L-asparaginase

DRUGPrednisone

Glucocorticoids

DRUGCytarabine

Pyrimidine antimetabolites

DRUG6-mercaptopurine

Cell cycle-specific antitumor drug

DRUGDexamethasone

Glucocorticoids

DRUGMethotrexate

Antifolate antineoplastic drug

DRUGVenetoclax

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


Locations(1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

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NCT05660473


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