Reduced-Dose Chemo Followed by 14 Days of Blinatumomab for Newly Diagnosed Adult B-ALL Patients: a Multicenter Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15-65
SponsorShandong University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Blinatumomab

Treatment groups

36 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

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