Combining a pediatric treatment approach with Venetoclax for young and adult patients with a specific type of leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of a pediatric-inspired treatment regimen combined with Venetoclax for adolescents and adults diagnosed with de novo Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL). The study aims to improve the rate of minimal residual disease (MRD)-negative complete remission after the initial treatment phase and to reduce the likelihood of relapse, thereby enhancing overall survival rates. Participants will receive a combination of chemotherapy agents including Vincristine, Daunorubicin, Cyclophosphamide, Pegaspargase, and Prednisone, alongside Venetoclax, which is known for its role in targeting B-cell lymphoma. The trial is designed for patients aged 14 to 60 years who meet specific health criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• Institute of Hematology & Blood Diseases Hospital
  Tianjin, China Recruiting

Study contacts

• Principal investigator: Jianxiang Wang, Dr — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Jianxiang Wang, Dr
• Email: wangjx@ihcams.ac.cn
• Phone: 86-22-23909120

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.