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

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adolescents and adults with a specific type of leukemia called Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL). Researchers are looking at whether a combination of a treatment plan inspired by successful pediatric treatments and a medication called venetoclax can improve patient outcomes. The goal is to increase the rate of patients achieving a complete remission (when the disease is no longer detectable) and to reduce the chances of the leukemia coming back.

To be eligible for this trial, participants should be between 14 and 60 years old and have a confirmed diagnosis of Ph- ALL. They should also have a good overall health status, meaning they can carry out daily activities with minimal restrictions. Patients will need to provide written consent to participate. Throughout the trial, participants can expect close monitoring and support from the research team as they undergo this combined treatment. This study is currently recruiting participants, and it aims to improve survival rates for those affected by this challenging disease.

Gender

ALL

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

Trial Officials