Thrombocytopenia caused by chemotherapy for acute leukemia
Conditions
Interventions
First Dose Group:Intravenous injection of 0.5 therapeutic dose of platelets
Second Dose Group:Intravenous injection of 1 therapeutic dose of platelets
Sponsors
Hematology and Oncology Department, Shanghai Children's Medical Center
Eligibility
Sex/Gender
All
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria: 1) Participants must be 14 years old or older, with no gender restrictions; 2) Diagnosis of acute leukemia confirmed through pathological histology or cytology examination (excluding induction therapy and acute promyelocytic leukemia), with ongoing chemotherapy treatment; 3) Platelet count between 10×10*9/L and 30×10*9/L (requires reconfirmation on screening day D-1, eligibility should meeting this criterion); 4) Absence of peripheral blood platelet transfusions in the three days prior to receiving human-induced pluripotent stem cell-derived platelets; 5) ECOG score of = 2; 6) Participants and/or their guardians (if applicable) must comprehend and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will not be allowed to enter this study: 1) History of ineffective platelet transfusion (Ineffective platelet transfusion refers to a patient remaining unresponsive after receiving a sufficient dose of platelet transfusion on two consecutive occasions, characterized by a lack of improvement in clinical bleeding manifestations, no significant increase in platelet count, sometimes even a decrease, short survival period of transfused platelets in the body, failure of corrected count increment (CCI) and post-transfusion platelet recovery (PPR) to reach the standard within 20-24 hours with CCI <4.5×10^9/L and/or PPR <20%); 2) Previous severe transfusion-related allergic reactions; 3) Patients with relapsed leukemia or not meet complete remission (CR); 4) Patients with existing severe bleeding (such as intracranial hemorrhage, severe gastrointestinal bleeding, or severe hemoptysis); 5) Patients with hemophilia and coagulation disorders; 6) History of thrombotic or embolic disease (deep vein thrombosis, arterial thrombosis) within the 6 months prior to screening; 7) Occurrence of cardiac disease within 3 months before screening, or a significant history of cardiovascular disease (such as congestive heart failure (New York Heart Association functional classification 3/4), known arrhythmias increasing the risk of thromboembolic events [e.g., atrial fibrillation, atrial flutter, unstable angina], coronary artery stent placement, angioplasty, or coronary artery bypass grafting); 8) History of pulmonary embolism and hepatic vein thrombosis; 9) Patients with PICC-related thrombosis within the month preceding medication administration; 10) History of chronic thrombocytopenia or bleeding disorders, or thrombocytopenia not caused by CIT (e.g., thrombocytopenia due to chronic liver disease or autoimmune disease, thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, or immune thrombocytopenic purpura); 11) Patients with disseminated intravascular coagulation; 12) Enlarged spleen (spleen length greater than 18 cm) or hyperfunctioning spleen; 13) Use of anticoagulant medications within 7 days before screening, such as vitamin K antagonists, low molecular weight heparin (excluding cases of minor heparin use for catheter sealing), factor Xa inhibitors like rivaroxaban, and/or thrombin inhibitors, and/or antiplatelet therapy (e.g., taking aspirin); 14) Patients with moderate or severe liver and kidney dysfunction; 15) Individuals with positive results in screening for antibodies against the human immunodeficiency virus or specific antibodies against Treponema pallidum (the causative agent of syphilis); or those who test positive for hepatitis C antibodies, hepatitis B surface antigen, or have a history of hepatitis B, or individuals with positive hepatitis B core antibodies and HBV-DNA =2000 IU/mL in the past 3 months; 16) Individuals with uncontrolled active infections; 17) Body weight exceeding 80 kg; 18) Have undergone hematopoietic stem cell transplantation and have an acute graft-versus-host disease that requires control; 19) Women of childbearing age who are pregnant or breastfeeding, and male participants who plan to donate sperm within 180 days after medication administration; 20) The investigator believes that due to any medical condition, the assessment cannot be part of this study, or the participant is unable to complete the follow-up investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and Severity of Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Corrected Count Increment (CCI);Platelet Recovery Rate;Hemostasis Function PFA-200; | — |
Countries
CHINA
Contacts
Public ContactSHUHONG SHEN
Hematology and Oncology Department, Shanghai Children's Medical Center
Outcome results
None listed