Acute lymphoblastic leukemia (ALL) and NK/T cell lymphoma
Conditions
Interventions
1500 IU/m3:Subjects will receive combination chemotherapy containing QHRD102 every 28 days for a maximum of 4 cycles, depending on their treatment group and according to the study plan.The study drug
2000 IU/m3:Subjects will receive combination chemotherapy containing QHRD102 every 28 days for a maximum of 4 cycles, depending on their treatment group and according to the study plan.The study drug
2500 IU/m3:Subjects will receive combination chemotherapy containing QHRD102 every 28 days for a maximum of 4 cycles, depending on their treatment group and according to the study plan.The study drug
Sponsors
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be considered for inclusion: 1.Aged 18~75 years (including boundary value); 2.Patients diagnosed with recurrent or refractory T-ALL, B-ALL, and ENKTL (nasal type); 3.The Eastern Oncology Collaboration Group (ECOG) had a physical status score of = 25g/L; TBI = 50 mL/min; 3) Coagulation function INR = 1.5g/L; 4) AMY <= 1.5ULN,LPS<= 1.5ULN; 6.The women of childbearing age had negative serum pregnancy test within 7 days before treatment; 7.Subjects can provide pre-treatment diagnostic evidence or receive bone marrow puncture or biopsy for diagnosis, and agree to receive bone marrow puncture, biopsy or CT examination for efficacy evaluation after treatment; 8.Voluntarily participate in this study, fully understand the relevant risks, good compliance, and signed the informed consent; 9.Consent effective contraceptive measures during the trial period and within 6 months of the last study drug administration.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of Burkitt leukemia/lymphoma, mixed phenotype acute leukemia, or Philadelphia chromosome positive ALL (pH +ALL); 2.Central nervous system invasion; 3.Chemotherapy (including dexamethasone) within 2 weeks before the first administration, radiotherapy or major surgery within 4 weeks, immunotherapy within 12 weeks, and anti-tumor traditional Chinese medicine treatment within 2 weeks; Other antitumor agents treat within 5 half-lives. 4.Patients who have a history of solid organ transplantation or who have received allogeneic hematopoietic stem cell transplantation;Or had received autologous hematopoietic stem cell transplantation within 6 months prior to the first medication; 5.Participated in a clinical trial drug study or is in other interventional clinical trials within 4 weeks prior to the first administration; 6.Patients with a history of severe drug allergy or allergic history of this drug component; 7.Patients with a history of pancreatitis; 8.Diabetics with poor control; 9.Severe cardiovascular disease, such as 1) Significant heart disease, such as congestive heart failure (NYHA grade III or grade IV heart failure), myocardial infarction, unstable angina, etc.; 2) Significant ECG abnormalities, such as any grade of atrial fibrillation, grade II type II atrioventricular block or grade III atrioventricular block or QTCF interphase > 450mS in men and BBB > 0ms in women; 3) other uncontrolled symptomatic arrhythmias; 4) Poorly controlled hypertension (SBP > 150 mmHg and/or DBP>100 mmHg); 10.History of cerebrovascular disease (including atherosclerosis, cerebral thrombosis, cerebral hemorrhage or transient ischemic attack) or other thrombosis (pulmonary embolism, deep vein thrombosis, etc.). 11.Congenital or acquired hemorrhagic diseases (such as coagulation factor deficiency, immune thrombocytopenic purpura, etc.; Except thrombocytopenia caused by leukemia and lymphoma);Suffering from severe gastrointestinal ulcers, bronchiectasis and other diseases that may cause bleeding;Receiving thrombolysis or anticoagulant therapy; 12.Active infection occurred 2 weeks before administration. 13.Active autoimmune diseases (except those caused by lymphoma); 14.Human immunodeficiency virus infection (anti-HIV positive), active hepatitis B (HBsAg+, or HBcAb+ with HBV DNA PCR results equal to ULN), active hepatitis C (anti-HCV + with HCV RNA PCR results greater than or equal to ULN), or syphilis infection (anti-TP positive) are known. 15.History of other malignant tumors (except clinically cured basal cell carcinoma of the skin, squamous cell carcinoma, or other tumors with no recurrence within 5 years); 16.Current existence of a definite neurological or psychiatric disorder that affects judgment or the collection of relevant information, or prior diagnosis of epilepsy; 17.History of alcohol, drug or drug abuse; 18.Pregnant, lactating women or men and women planning to have a family; 19.Any other disease or history of clinical significance that the Investigator assesses may pose a risk to the safety of the Subject or interfere with the completion of the study; 20.Any other circumstances under which the Investigator deems the Subject unsuitable to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;PK;PD; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity;Efficacy evaluation; | — |
Countries
China
Contacts
Public ContactQi Junyuan
Outcome results
None listed