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

Korábbi kezelés

• Previous or ongoing systemic anti-acute lymphoblastic leukemia (ALL) treatment (including but not limited to radiotherapy), except for appropriate pretreatment;
• Major surgery within the last 4 weeks or not recovered from previous surgery;

Más betegség

• 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;
• A history of definite neurological or psychiatric disorders, including epilepsy or dementia;
• Having other malignant tumors, unless the other primary malignant tumor is currently stable or does not require active intervention;
• Active severe infections that cannot be controlled by oral or intravenous antibiotics;
• Patients known to be allergic or contraindicated to the study drug (active pharmaceutical ingredient and/or excipients);
• Existence of bleeding disorders unrelated to ALL.

Laborértékek

• Clinically significant severe uncontrollable heart disease (including but not limited to a history of myocardial infarction, stroke, or revascularization; unstable angina or transient ischemic attack within 6 months before enrollment; congestive heart failure or left ventricular ejection fraction (LVEF) below the local institutional standard lower limit within 6 months before enrollment; a history of clinically significant (determined by the attending physician) atrial arrhythmia; a history of ventricular arrhythmia; a history of venous thromboembolism, including deep vein thrombosis or pulmonary embolism, uncontrollable hypertension, etc.);

Életkor

• Women of childbearing age or men who cannot use sufficient methods for contraception, including pregnant or lactating women;

Egyéb

• Clinical manifestations of central nervous system or extramedullary involvement at the time of diagnosis;
• Patients participating in other clinical studies simultaneously;
• Confirmed positive status for human immunodeficiency;

• 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.
• Cardiac color Doppler echocardiography ejection fraction ≥45%;
• Female patients of childbearing potential must have a negative pregnancy test (within 7 days prior to enrollment).