This is a prospective, multicenter, observational study aimed at exploring the efficacy and safety of reduced-dose chemotherapy followed by frontline therapy with blinatumomab in patients aged 15-65 with newly diagnosed Ph-negative B-ALL.
Age 15-65 years, both male and female are eligible;
Untreated newly diagnosed Ph-negative B-ALL patients; Diagnosis is defined by using morphological, immunological, cytogenetic, and molecular (MICM) diagnostic models, with immunotyping showing >20% primitive lymphoid cells in the bone marrow; bone marrow cytogenetics showing Philadelphia chromosome (Ph) negative (after observing at least 20 metaphases) and/or fluorescence in situ hybridization (FISH) BCR/ABL negative and/or molecular BCR/ABL fusion gene negative;
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2;
Organ function tests must meet all the following criteria: Total bilirubin <1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) <2.5×ULN (if liver is involved, then ALT and AST <5×ULN are allowed); Creatinine <1.5×ULN; Serum amylase and lipase ≤1.5×ULN; Alkaline phosphatase ≤2.5× ULN; Serum electrolytes potassium, magnesium, phosphorus within normal limits.
Previous or ongoing systemic anti-acute lymphoblastic leukemia (ALL) treatment (including but not limited to radiotherapy), except for appropriate pretreatment;
Clinical manifestations of central nervous system or extramedullary involvement at the time of diagnosis;
Patients participating in other clinical studies simultaneously;
Accompanying diseases that, in the judgment of the investigator, pose a serious risk to patient safety or affect the patient's ability to complete the study;
Patients aged 15-65 years newly diagnosed with Philadelphia chromosome-negative acute B-lymphoblastic leukemia, confirmed at Qilu Hospital of Shandong University and other participating institutions in Shandong Province.
Cohort
Prospective
Blinatumomab
DrugThe 14-day blinatumomab combined with reduced-dose chemotherapy is used for the induction treatment of newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia.
The overall response rate
The overall response rate after induction therapy = Complete Remission (CR) + CR with partial hematologic recovery (CRh) + CR with incomplete hematologic recovery (Cri).
Minimal Residual Disease (MRD) negativity rate after induction therapy
MRD negativity refers to a flow cytometry test result where MRD is less than 0.01%.
Complete molecular remission rate.
Complete molecular remission rate is defined as undetectable Ig rearrangement by next-generation sequencing, with a detection sensitivity of at least less than 10\^-5.
One-year overall survival rate.
The proportion of patients who are still alive one year after the date of disease diagnosis, out of the total number of subjects enrolled in the study.
One-year event-free survival rate
The proportion of patients who have not experienced disease progression, been diagnosed with another cancer, or died from any cause one year after the date of disease diagnosis, out of the total number of subjects enrolled in the study.
Safety
Safety endpoints are defined, graded, and evaluated according to the CTCAE version 5.0 criteria.
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Shandong University
Lead sponsor
Qilu Hospital of Shandong University
Sponsor institution
Shandong Provincial Hospital
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Tangshan Central Hospital
Collaborator
Affiliated Central Hospital of Shandong First Medical University
Collaborator
Yantai Yuhuangding Hospital
Collaborator
Qilu Hospital of Shandong University (Qingdao)
Collaborator
Qingdao Central Hospital
Collaborator
Qingdao Municipal Hospital
Collaborator
Affiliated Hospital of Jining Medical University
Collaborator
Affiliated Hospital of Binzhou Medical College
Collaborator
Linyi People's Hospital
Collaborator
The Second Hospital of Shandong University
Collaborator
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Collaborator
Shandong First Medical University
Collaborator
Shengli Oilfield Hospital
Collaborator
Heze Municipal Hospital
Collaborator
Zibo Central Hospital
Collaborator
Zaozhuang Municipal Hospital
Collaborator
Weihai Municipal Hospital
Collaborator
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