Safety and Efficacy of Umbilical Cord Blood Therapy for Cancer Therapy-Induced Thrombocytopenia (CTIT)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-65
SponsorZhejiang Cancer Hospital
About this trial
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 65 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 incidence, and hematological improvements.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 12 to 65 years at the time of signing the informed consent, regardless of gender.
Meets the diagnostic criteria for cancer treatment-induced thrombocytopenia (CTIT):Peripheral blood platelet count < 100 × 10⁹/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;
No significant hepatic or renal impairment: ALT and AST ≤ 2.5 × upper limit of normal (ULN), serum creatinine (Cr) and blood urea nitrogen (BUN) ≤ 1.25 × ULN;
Karnofsky Performance Status (KPS) score ≥ 60 (see Appendix 1), Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix 2);
Disqualifiers
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;
Use of non-anti-tumor medications known to cause thrombocytopenia (including but not limited to sulfonamides and other drugs);
Pseudothrombocytopenia induced by ethylenediaminetetraacetic acid (EDTA) anticoagulant;
Uncontrolled malignant tumor, hypertension, or diabetes mellitus;
Trial design
Design model
Single group
Treatments tested in this trial
umbilical cord blood
Other interventionUmbilical cord blood will be selected from a public cord blood bank, requiring an HLA match of 0-3/10, a total nucleated cell (TNC) count \>1 × 10⁷/kg, and ABO blood type identical to the recipient. The umbilical cord blood will be intravenously infused into the subject within 30 minutes.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Umbilical Cord Blood for CTIT TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment efficacy rate
Treatment efficacy rate: Post-treatment platelet count ≥100×10\^9/L, or an increase of ≥50×10\^9/L from baseline, or an increase of ≥100% from baseline.
Time frame
28 days post-infusion2
Treatment-related adverse events
Time frame
28 days post-infusionSecondary outcomes
1
(1)Platelet first response time and maximum and minimum platelet counts;
Platelet first response time: Time to first platelet count ≥100×10\^9/L without platelet transfusion and maximum and minimum platelet counts;
Time frame
28days post-infusion2
Incidence of bleeding events after initial infusion;
Time frame
28 days post-infusion3
Number of platelet transfusions;
Time frame
28 days post-infusion4
Changes in thrombocytopenia grading;
Time frame
28 days post-infusionSponsors and contacts
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Source ClinicalTrials.gov