Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults. Philadelphia chromosome positive (Ph+) ALL is defined as ALL with translocation between chromosomes 9 and 22. And t(9;22)(q34;q11) is the most common chromosomal abnormality in ALL. Before the emergence of TKI, the prognosis of Ph+ ALL was extremely poor, and the long-term survival rate was only 10%-35%. Ph+ ALL accounts for about 30% of adult ALL. In this study, the investigators propose a treatment approach that combines Venetoclax with Olverembatinib and Predinisone in Ph+ B-ALL adults. The study aims to answer the safety and efficacy of this treatment regimen, and further improve the survival for those participants.
This is a prospective, single-arm, phase II and open-label study. A total of 36 Ph-positive B-ALL participants will be enrolled. The primary endpoint is complete molecular response (CMR) after three cycles of venetoclax combined with olverembatinib and prednisone regimen (VOP) in the treatment of de novo acute Philadelphia chromosome-positive (Ph+) B-lymphoblastic leukemia. The purpose of this study is to explore the safety and efficacy of the multi-drug combination regimen in the treatment of newly diagnosed Ph-positive B-ALL patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
BCL-2 inhibotor
Tyrosine kinase inhibitor
Glucocorticoids
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGcomplete molecular response (CMR) after three cycles
BCR::ABL1≤0.01% detected by RT-qPCR
Time frame: At the end of Cycle 3(each cycle is 28 days)
Complete remission with or without incomplete PB cell recovery(CR/CRi) rate
Blast rate lower than 5% with or without peripheral blood cell recover
Time frame: after Cycle 1(each cycle is 28 days)
Event free survival (EFS)
Defined for all patients in a trial; measured from day 1 of treatment to the date of treatment failure, hematologic relapse from CR/CRi or death from any cause, whichever occurs first;
Time frame: up to 2 years
Overall survival (OS)
Defined for all patients in a trial; measured from day 1 of treatment to the date of death from any cause;
Time frame: up to 2 years
Minimal residual disease (MRD)
MRD level detected by flow cytometry which value \<0.1% is defined as negtive; MRD level detected by RT-qPCR which BCR::ABL1 value \<0.01% is defined as negtive
Time frame: At the end of each cycle(each cycle is 28 days), up to 2 years
Relapse free survival(RFS)
Defined only for patients achieving CR or CRi; measured from the date of achievement of remission until the date of hematologic relapse or death from any cause;
Time frame: up to 2 years
Incidence of Adverse Events
The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.Hematologic and non-hematologic toxicity.
Time frame: From day 1 of treatment to 28 days after the last dose
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