๐ฌIn plain words
What the trial is, and whether it could suit you
This study is a prospective, single-center, open-label, single-arm clinical trial to assess the safety and efficacy of umbilical cord blood in cancer treatment-induced thrombocytopenia (CTIT) patients. It plans to recruit subjects aged 12 to 75 years old with CTIT. The study involves intravenous infusion of umbilical cord blood, with platelet transfusion as supportive therapy if necessary. The trial consists of three phases: screening (baseline assessments and enrollment), treatment (umbilical cord blood infusion), and follow-up (blood routine tests at Days 3, 7, 14, and 28 post-treatment to record platelet counts, first response time, maximum and minimum values, and calculate efficacy rates while observing changes in thrombocytopenia grading). A total of 25 subjects will be enrolled, and they will undergo evaluation for safety and efficacy based on treatment-related adverse events, GVHD
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Aged 12 to 75 years at the time of signing the informed consent, regardless of gender.
2. Meets the diagnostic criteria for cancer treatment-induced thrombocytopenia (CTIT):Peripheral blood platelet count \< 100 ร 10โน/L; Prior definite exposure to a chemotherapy agent (or tumor-targeted therapy, immunotherapy, or other anti-tumor drugs) known to cause thrombocytopenia, with gradual improvement of thrombocytopenia-related symptoms/signs or normalization of platelet count after discontinuation of the offending drug; Presence or absence of bleeding tendency, such as petechiae, purpura, unexplained epistaxis, or even severe organ/tissue hemorrhage;
3. No significant hepatic or renal impairment: ALT and AST โค 2.5 ร upper limit of normal (ULN), serum creatinine (Cr) and blood urea nitrogen (BUN) โค 1.25 ร ULN;
4. Karnofsky Performance Status (KPS) score โฅ 60 (see Appendix 1), Eastern Cooperative Oncology Group (ECOG) performance status โค 2 (see Appendix 2);
5. Estimated life expectancy of more than 3 months.
Exclusion Criteria:
1. Other causes of thrombocytopenia, in particular exclusion of underlying diseases or comorbidities such as aplastic anemia, acute leukemia, radiation sickness, immune thrombocytopenia (ITP), hypersplenism, or bone marrow infiltration by tumor cells;
2. Use of non-anti-tumor medications known to cause thrombocytopenia (including but not limited to sulfonamides and other drugs);
3. Pseudothrombocytopenia induced by ethylenediaminetetraacetic acid (EDTA) anticoagulant;
4. Uncontrolled malignant tumor, hypertension, or diabetes mellitus;
5. Active infection, including but not limited to known HIV positivity, active hepatitis B or C, or syphilis;
6. Poor compliance;
7. Known allergy or hypersensitivity to any component of the study intervention (umbilical cord blood or related products);
8. Participation in another clinical trial within 1 month prior to enrollment or current participation in another clinical trial;
9. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this clinical study.
Department of Hematology, Zhejiang Cancer Hospital
Hangzhou, China
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.