Umbilical cord blood therapy for cancer treatment–related low platelets

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, open-label, single-arm Phase 2 trial enrolling 25 participants with thrombocytopenia caused by prior cancer therapy. Participants receive an intravenous infusion of HLA 0–3/10 matched umbilical cord blood (TNC > 1×10^7/kg, ABO matched) and are followed with blood tests on Days 3, 7, 14, and 28 to record platelet counts, response timing, and peak/trough values. Supportive platelet transfusions are allowed if clinically needed, and safety monitoring focuses on treatment-related adverse events and graft-versus-host disease (GVHD). The primary outcome is a predefined platelet response (≥100×10^9/L, or rise ≥50×10^9/L, or ≥100% increase from baseline) with secondary measures including bleeding events, transfusion requirement, and changes in thrombocytopenia grade.

Why it matters

Who can join: the full rules

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 × 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;
3. 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;
4. Karnofsky Performance Status (KPS) score ≥ 60 (see Appendix 1), Eastern Cooperative Oncology Group (ECOG) performance status ≤ 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.

Where it's running

• Department of Hematology, Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Xiaolin Yuan
• Email: yuanxiaolinhaha@163.com
• Phone: +86 057188122153

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.