relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia or T-cell acute lymphoblastic lymphoma
Conditions
Interventions
Dose Group 1a:APG-1252, 100mg/m^2 ,oral,D1,4,11,18,25
Dose Group 2a:APG-1252, 75mg/m^2 ,oral, D1,4,8,12,15,19,22
Dose Group 1b:APG-1252, 75mg/m^2, oral, D1,4,11,18,25
Dose Group 1c:APG-1252, 50mg/m^2, oral, D1,4,11,18,25
Sponsors
Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
Inclusion criteria: Patients who meet each of the following inclusion criteria are eligible to participate in this study: 1. Age: Phase 1 >=10 years old, Phase 2 >=3 years old; 2. Diagnosed with one of the following diseases based on cytology/pathology and immunophenotyping; a. Philadelphia chromosome-positive acute lymphoblastic leukemia; b. T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma; 3. One of the following two conditions: a. Bone marrow relapse (MRD>=20%); b. MRD>=5% after the end of induction therapy (day 33 of induction therapy); 4.Patients or their family members voluntarily participate in this trial and sign an informed consent form; 5. Performance status: Patients =50, patients >16 years old with Karnofsky score >=50%; 6. Major organ functions meet the following criteria: Liver function: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =60 mL/min/1.73m^2; Cardiac function: Left ventricular ejection fraction (EF) >=50%.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria are not suitable for participation in this study 1.Children with Down syndrome, or congenital or hereditary diseases associated with organ dysfunction; 2.Central nervous system involvement: CNS3 status in cerebrospinal fluid or visible parenchymal lesions on imaging that cannot rule out tumor infiltration; 3.Isolated testicular relapse: Ultrasound diagnosis of testicular infiltration, with or without testicular enlargement or hardening; 4.Congenital immunodeficiency or metabolic diseases; 5.Heart failure (ejection fraction =2 according to NCI CTCAE 5.0 grading); 11.Patients with T-ALL/LL who have been treated with olverembatinib, dasatinib, or similar chemical drugs for more than >=5 days without significant efficacy 2: or patients intolerant to the study drugs; 12. Within 3 days prior to the first administration of the study drug, patients who have used drugs with potential drug-drug interactions due to concurrent diseases (such as potent CYP2C9 inducers or inhibitors, moderate to potent CYP3A4 inducers or inhibitors); 13.Life-threatening severe organ dysfunction, including but not limited to: cardiovascular and cerebrovascular diseases, symptomatic heart failure, severe respiratory diseases, significant renal, neurological, endocrine, metabolic, immune, liver, gastrointestinal diseases, or mental/social conditions that may affect study compliance; 14.Severe arrhythmias within the past 3 months (including but not limited to left bundle branch block, frequent ventricular premature beats, ventricular tachycardia, supraventricular tachycardia, second-degree type II atrioventricular block, third-degree block, atrial fibrillation requiring drug control, etc.), or other cardiac events deemed unsuitable for the study by the investigator; 15.Congenital immunodeficiency syndrome; 16.Active infection requiring systemic antifungal/bacterial/viral therapy, including but not limited to HIV antibody positivity; Positive hepatitis C antibody or hepatitis C RNA greater than the upper limit of normal; HBsAg positive and HBV-DNA greater than the reference value range of the center; Within 1 week after COVID-19 infection has normal body temperature, or has pneumonia that has not been absorbed, or within 1 week after recovery from other severe manifestations; 17. Diseases that significantly affect drug oral intake and absorption, or active gastrointestinal ulcers; 18.History of organ transplantation (excluding hematopoietic stem cell transplantation); 19.Grade 2 or higher GVHD persisting after hematopoietic stem cell transplantation; 20.Non-tumor-related bleeding disorders: such as congenital bleeding disorders (e.g., von Willebrand disease)acquired bleeding disorders diagnosed within 1 year (e.g., acquired inhibitors of coagulation factor VIII, etc.); 21.Patients who have undergone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peripheral Blast Reduction Rate, PBRR;Bone marrow blast;Bone marroe MRD; | — |
Countries
China
Contacts
Public ContactShuhong Shen
Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University
Outcome results
None listed