Acute B-cell Lymphoblastic Leukemia
Conditions
Interventions
The bellintumab group:None
Traditional chemotherapy group:None
Sponsors
Union Hospital Affiliated to Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male patients or non-pregnant, non-lactating female patients aged >=18 years; 2. Adult patients with newly diagnosed Ph+ B-ALL confirmed by cytogenetics/FISH and/or BCR-ABL PCR. 3. Pre-enrollment white blood cell (WBC) count =50%; 5. Renal function: Serum creatinine (Cr) <= 2 × ULN; 6. Serum total bilirubin (TBIL) <= 2 × ULN, or TBIL <= 3 × ULN if elevated due to leukemia or Gilbert syndrome; 7. Serum transaminases <= 2.5 × ULN, or serum transaminases <= 5 × ULN (if transaminase elevation is considered due to leukemia infiltration); 10. Female subjects of childbearing potential or male subjects with female partners of childbearing potential must use effective contraception throughout the treatment period and for 6 months post-treatment; 8. Able to tolerate bone marrow aspiration and biopsy, and undergo these procedures at protocol-specified time points. 9. Sign a written informed consent form and be able to comply with protocol-mandated visits and related procedures.
Exclusion criteria
Exclusion criteria: 1. Received antineoplastic biological therapy (e.g., monoclonal antibodies) within 12 weeks prior to first administration; 2. Active, known, or suspected autoimmune disease; 3. Pregnant or lactating women; 4. History of solid organ transplantation; 5. Symptomatic central nervous system leukemia or presence of suspected neurological events; 6. Severe interstitial lung disease or active pneumonia; 7. Other major clinically uncontrolled diseases or infections; 8. Known history of systemic autoimmune diseases; Exclusion Criteria (II) Uncontrolled concomitant diseases include but are not limited to: 1. HIV infection (HIV antibody positive); 2. Active or poorly controlled severe infection; 3. Symptomatic congestive heart failure (New York Heart Association Class II–IV) or symptomatic or poorly controlled arrhythmia; 4. Uncontrolled hypertension despite standard therapy (systolic >=160 mmHg or diastolic >=100 mmHg); 5. Any arterial thromboembolic event within 6 months prior to study entry, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; 6. Esophageal or gastric varices requiring immediate intervention (e.g., banding or sclerotherapy), or subjects deemed at high bleeding risk based on investigator judgment or consultation with a gastroenterologist or hepatologist, with evidence of portal hypertension (including splenomegaly on imaging) or prior variceal bleeding history must undergo endoscopic evaluation within 3 months prior to enrollment; 7. History of gastrointestinal perforation and/or fistula within 6 months prior to study enrollment; Exclusion Criteria (III) Uncontrolled concomitant diseases, including but not limited to: 1. Any life-threatening bleeding events occurring within 6 months prior to study enrollment, such as intracranial hemorrhage or Grade 3 or 4 gastrointestinal/variceal bleeding requiring transfusion, endoscopic intervention, or surgical treatment; 2. History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolic events within 6 months prior to enrollment (thrombosis associated with implantable venous access ports or catheters, or superficial vein thrombosis is not considered "severe" thromboembolism); 3. Uncontrolled metabolic disorders or other non-malignant organ diseases, systemic conditions, or cancer-related sequelae that may pose significant medical risks and/or introduce uncertainty in survival assessment; 4. Hepatic encephalopathy, hepatorenal syndrome, or cirrhosis with Child-Pugh grade B or higher; 5. History of intestinal obstruction or the following conditions: inflammatory bowel disease or extensive intestinal resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea; 6. Other acute or chronic diseases, psychiatric conditions, or abnormal laboratory values that may result in: increased risks associated with study participation or study drug administration, or interfere with the interpretation of study results, and which, in the investigator's judgment, would disqualify the subject from participating in this study; 7. Acute or chronic active hepatitis B or hepatitis C infection: HBsAg positive with hepatitis B virus (HBV) DNA > 200 IU/mL or 1000 copies/mL; hepatitis C virus (HCV) antibody positive with RNA positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal Residual Disease (MRD) Negativity Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Overall Survival (OS);Relapse Rate; | — |
Countries
China
Contacts
Public ContactXu Shujuan
Union Hospital Affiliated to Fujian Medical University
Outcome results
None listed