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. Traditional treatment regimens mainly include chemotherapy and hematopoietic stem cell transplantation. In the past decade, with the application of molecular targeted drugs and immunotherapy, the survival of B-ALL patients has significantly improved. In this study,we propose a treatment approach that combines Blinatumomab and Venetoclax sequenced with Inotuzumab Ozogamicin in B-ALL adults. Our 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 20 Ph-negative B-ALL participants will be enrolled. The primary endpoint is 2-year event free survival(EFS). The induction therapy is a combination of Blinatumomab(Blina), Venetoclax(Ven) and Dexamethasone(DXM), and would be applied for two cycles. As for consolidation, the Inotuzumab Ozogamicin(INO) would be given on cycle 3 and cycle 5. The high dose of MTX would be given on Cycle 4 and the Ven plus L-asp would ben given on Cycle 6. Subsequent maintenance therapy contains of low dose of Chemotherapy, Blina and INO. The purpose of this study is to explore the safety and efficacy of the whole-process management of multi-drug combination regimen in the treatment of newly diagnosed Ph-negative B-ALL patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Glucocorticoids
Bi-specific anti CD19/CD3 antibody
BCL-2 inhibotor
a humanized monoclonal antibody-drug conjugate targeting CD22
antifolate antineoplastic drug
antitumor drug
Pyrimidine, antimetabolites
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGEvent 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
Complete remission with or without incomplete PB cell recovery(CR/CRi) rate
Blast rate lower than 5% with or without peripheral blood cell recovery
Time frame: at the end of Cycle 1(each cycle is 28days)
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 5 years
Minimal residual disease (MRD)
MRD level detected by flow cytometry which value \<0.1% is defined as negtive
Time frame: At the end of Cycle 1(each cycle is 28 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.