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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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)
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
RECRUITINGMRD-negative complete remission rate measured by flow cytometry
Time frame: After induction (4 week)
Complete remission (CR) rate
Time frame: After 2 cycles of chemotherapy, an expected average of 3 months
Overall survival (OS)
From the date of registration to the date of death resulting from any cause
Time frame: Up to 5 years post-registration
Relapse free survival (RFS)
From the date of complete remission(CR) until the date of documented relapse or death due to any cause or the last follow-up day
Time frame: Up to 5 years post-registration
Disease-free Survival (DFS)
From CR1 to relapse, death from any cause or last follow-up
Time frame: Up to 5 years post-registration
The rate of adverse events
Time frame: An expected average of 24 months
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