The Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery of Patients After sUCBT
- Registration Number
- NCT06558253
- Lead Sponsor
- Anhui Provincial Hospital
- 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 transplantation in hematological malignancies.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Coenzyme I for Injection Coenzyme I for Injection Subjects received 21 consecutive days of intravenous infusion of Coenzyme I for injection with three dose groups.
- Primary Outcome Measures
Name Time Method Adverse Event(AE) From the date of initial treatment to 30 days after transplantation Number of treatment-related adverse events as assessed by CTCAE v5.0
- Secondary Outcome Measures
Name Time Method Probability of overall survival 180 days post transplantation Probability of overall survival on day 180 post transplantation.
Probability of leukemia-free survival 180 days post transplantation Probability of leukemia-free survival on day 180 post transplantation.
Cumulative incidence of grade II-IV and III-IV acute GVHD on day 100 100 days post transplantation Cumulative incidence of grade II-IV and III-IV acute GVHD on day 100 post transplantation.
Cumulative incidence of relapse on day 180 180 days post transplantation Cumulative incidence of relapse on day 180 post transplantation.
Cumulative incidence of primary graft failure on day 30 30 days post transplantation Cumulative incidence of primary graft failure on day 30 post transplantation.
Cumulative incidence of platelet engraftment on day 60 60 days post transplantation Cumulative incidence of platelet engraftment on day 60 post transplantation.
Cumulative incidence of transplant-related mortality on day 180 180 days post transplantation Cumulative incidence of transplant-related mortality on day 180 post transplantation.
Probability of GVHD-free relapse-free survival 180 days post transplantation Probability of GVHD-free relapse-free survival on day 180 post transplantation.
Neutrophil engraftment time 42 days post transplantation The first day of absolute neutrophil count ≥ 0.5×10\^9/L for 3 consecutive days post transplantation.
Cumulative incidence of neutrophil engraftment on day 16 16 days post transplantation Cumulative incidence of neutrophil engraftment on day 16 post transplantation.
platelet engraftment time 180 days post transplantation The first day of platelet count ≥ 20×10\^9/L for 7 consecutive days without platelet transfusions for 7 consecutive days post transplantation.
Trial Locations
- Locations (1)
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
🇨🇳Hefei, Anhui, China