Actively Recruiting

Phase 2
Age: 12Years - 65Years
All Genders
NCT07441720

Safety and Efficacy of Umbilical Cord Blood Therapy for Cancer Therapy-Induced Thrombocytopenia (CTIT)

Led by Zhejiang Cancer Hospital · Updated on 2026-05-11

25

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Safety and Efficacy of Umbilical Cord Blood Therapy for Cancer Therapy-Induced Thrombocytopenia (CTIT)

Who Can Participate

Age: 12Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 12 to 65 years at the time of informed consent, regardless of gender
  • Diagnosed with cancer treatment-induced thrombocytopenia (CTIT) with platelet count below 100 x 10^9/L
  • Previous exposure to chemotherapy, tumor-targeted therapy, immunotherapy, or other anti-tumor drugs causing thrombocytopenia
  • Gradual improvement or normalization of platelet count after stopping the offending drug
  • May have bleeding symptoms such as petechiae, purpura, unexplained nosebleeds, or severe bleeding
  • No significant liver or kidney impairment: ALT and AST ≤ 2.5 times upper limit of normal, creatinine and blood urea nitrogen ≤ 1.25 times upper limit of normal
  • Karnofsky Performance Status score of 60 or higher and ECOG performance status 0 to 2
  • Estimated life expectancy of more than 3 months
Not Eligible

You will not qualify if you...

  • Thrombocytopenia caused by other diseases like aplastic anemia, acute leukemia, radiation sickness, immune thrombocytopenia, hypersplenism, or bone marrow infiltration by tumor cells
  • Use of non-anti-tumor drugs known to cause thrombocytopenia
  • Pseudothrombocytopenia caused by EDTA anticoagulant
  • Uncontrolled cancer, high blood pressure, or diabetes
  • Active infections such as HIV, hepatitis B or C, or syphilis
  • Poor compliance with study requirements
  • Known allergy or sensitivity to umbilical cord blood or related products
  • Participation in another clinical trial within one month before enrollment
  • Any other condition that the investigator judges as unsuitable for participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Hematology, Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

X

Xiaolin Yuan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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