Status:
RECRUITING
The Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery of Patients After sUCBT
Lead Sponsor:
Anhui Provincial Hospital
Conditions:
Hematopoietic Recovery
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
To assess the safety and efficacy of coenzyme I for injection in promoting hematopoietic recovery after single-unit unrelated cord blood transplantation in hematological malignancies.
Detailed Description
A single-center, open-label, dose-escalation study to assess the safety and efficacy of coenzyme I for injection in promoting hematopoietic recovery after single-unit unrelated cord blood transplantat...
Eligibility Criteria
Inclusion
- Age between 18 and 60 years (inclusive) at screening; gender is not restricted;
- Diagnosed with hematological malignancies to receive sUCBT for the first time;
- No severe organ failure and no active infections
- ECOG performance status of 0-2;
- Voluntarily participating in the clinical trial, with full understanding of the trial details and having signed the informed consent form.
Exclusion
- Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas;
- Pregnant patients;
- Patients and/or authorised family members who refuse to receive Coenzyme I for Injection;
- Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise patient safety and put the results of the study at undue risk; drug-dependent individuals; patients with uncontrolled psychiatric disorders; and individuals with cognitive impairment;
- Participants in other clinical studies affecting hematopoietic recovery within 3 months;
- Those who are considered by the investigator to be unsuitable for enrolment (e.g., those who anticipate that the patient will not be able to adhere to the examination and treatment due to financial or other issues).
Key Trial Info
Start Date :
November 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06558253
Start Date
November 29 2024
End Date
September 30 2026
Last Update
December 18 2024
Active Locations (1)
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1
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China, 230036