Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia
Institute of Hematology & Blood Diseases Hospital, China
100 participants
Aug 1, 2022
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
Inclusion Criteria6
- 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 Criteria10
- 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
Interventions
Anti-tumor alkaloids
Anthracycline
Alkylating agent
Polyethylene glycol (PEG) conjugated to L-asparaginase
Glucocorticoids
Pyrimidine antimetabolites
Cell cycle-specific antitumor drug
Glucocorticoids
Antifolate antineoplastic drug
Selective inhibitor of B-cell lymphoma 2 (Bcl-2)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05660473